Pregnancy Test Index

Below, you’ll find a convenient Pregnancy Test Sensitivity Index that will help you quickly compare pregnancy tests based on their HCG cut off and clinical sensitivity ratings.

NOTE: CPG Health publishes information regarding pregnancy tests and pregnancy testing for informational purposes only. We provide NO WARRANTY either expressed or implied regarding the accuracy, authenticity, or relevance of the material we publish.

NOTE: CPG Health does NOT provide medical advice of any kind. If you have questions about your health or pregnancy, ask them to a doctor or similar qualified medical professional.

Do you want to go straight to our Pregnancy Test Index information? Use the following table of contents.

Contents show

What is Pregnancy Test sensitivity?

Sensitivity refers to the amount of HCG required in your urine before showing a positive result.

Pregnancy tests have two different sensitivity ratings: Cut Off and Clinical.

What is Pregnancy Test Cut Off sensitivity

Pregnancy test cut off sensitivity refers to the minimum level of HCG required for more than 50% of pregnant women to receive a positive result.

What is Pregnancy Test Clinical sensitivity?

Pregnancy test clinical sensitivity refers to the minimum level of HCG required for 100% of pregnant women to receive a positive result.

What are the best FDA resources for pregnancy tests?

You will find most FDA pregnancy test data in either:

The FDA’s OTC Database, or
The FDA’s Premarket Notification Database, or
AccessGUIDID – Identify your medical device.
FDA Establishment Registration & Device Listing.

The CPG Health Pregnancy Test Index (below) contains direct links to FDA documentation.

CPG Health Pregnancy Test Index

Browse the CPG Health Pregnancy Test Index. Pregnancy Tests are listed in alphabetical order.

Accu Clear Pregnancy Test

Alternate Name: FPPL Accuclear Visual Pregnancy Stick

HCG Cut Off Sensitivity: Unknown
HCG Clinical/Analytical Sensitivity: 25 mIU/mL
FDA Document #K042280
Manufacturer: SPD SWISS PRECISION DIAGNOSTICS GMBH (Specification Developer).
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00751774975901

Get Accu Clear Pregnancy Test

Assured Pregnancy Test

HCG Cut Off Sensitivity: 25 mIU/mL.
HCG Clinical Sensitivity: 35 mIU/mL.
FDA Document #K123703, K103574.
Manufacturer: HEALGEN SCIENTIFIC, LLC
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00639277288912

Assured Pregnancy Test Instructions.

Get the Assured Pregnancy Test

Clearblue Digital with Smart Countdown

HCG Cut Off Sensitivity: 9 to 10 mIU/mL.
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.

FDA Document #
Manufacturer:
Access GUDID URL:

NOTES: This device is identical to the Equate Digital Pregnancy Test.

Clearblue Early Detection Pregnancy Test

Get it now from Amazon.

Clearblue Early Digital Pregnancy Test

Get it now from Amazon.

Clinical Guard Pregnancy Tests Early Detection Strips

HCG Cut Off Sensitivity: Unknown
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.

Sample UPC: 897429002841
FDA Document #NA
Manufacturer: Clinical Guard
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00897429002841

NOTES: NA

Get Clinical Guard Pregnancy Tests from Amazon using our link.

CVS Advanced One Step Pregnancy Test (Blue Box)

Alternate Name: CVS DPS Advanced +/- Blue Cap 2ct.
Alternate Name: Clearblue Rapid Detection Pregnancy Test.
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
HCG Cut Off Sensitivity: Unknown.
HCG Clinical/Analytical Sensitivity: 25mIU/mL.

Device Description: Advanced One Step Pregnancy Test.
FDA Document #: K042280.
Manufacturer: Unipath, LTD., Now known as SPD Swiss Protection Diagnostics GmbH.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428643112

CVS Digital & Early Result Pregnancy Test Kit (Red Box)

Alternate Name: CVS Health Digital & Early Result Pregnancy Test Kit.
Alternate Name (Early Result): FACT PLUS ONE-STEP PREGNANCY TEST KIT.
Alternate Name (Digital): Clearblue Easy Digital Pregnancy Test.
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.
HCG Cut Off Sensitivity (Early Result): Unknown.
HCG Clinical/Analytical Sensitivity (Early Result): 25mIU/mL.
HCG Cut Off Sensitivity (Digital): 9-10 mIU/mL.
HCG Clinical/Analytical Sensitivity (Digital): 25mIU/mL.

Device Description: A convenience kit consisting of 1 CVS Pregnancy Digital Pregnancy Test and 1 CVS Early Result Pregnancy Test.
FDA Document #: K042280.
FDA Document (Digital) #: K060128.
Manufacturer: Unipath, LTD.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428414422

CVS Digital & One Step Pregnancy Test Kit (Blue Box)

UPC: 050428347522
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Manufacturer: Unipath, LTD
FDA Document #: K042280
Access GUDID ULR: AccessGUDID – 00050428347522 (nih.gov)

NOTES: This product contains 2 pregnancy tests, (1) Digital and (1) One-Step. FDA records list this product only as (1) One-Step, ignoring the Digital Pregnancy Test included in the box.

CVS Digital Pregnancy Test (Red Box)

Alternate Name: CVS Health Digital Pregnancy Test Early Result.
Alternate Name: CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER).
Alternate Name: CLEARBLUE EASY DIGITAL PREGNANCY TEST
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

HCG Cut Off Sensitivity: 9-10 mIU/mL.
HCG Clinical/Analytical Sensitivity: 25mIU/mL.

Device Description: CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER).
FDA Document #: K060128.
Manufacturer: Unipath, LTD.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428255445.

CVS Digital Pregnancy Test (Blue Box)

Alternate Name: CVS Health Digital Pregnancy Test.
Alternate Name: CB8 PL Digital Pregnancy Stick CVS DPS Yes/No Digital.
Alternate Name: CLEARBLUE EASY DIGITAL PREGNANCY TEST.
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

HCG Cut Off Sensitivity: 9-10 mIU/mL.
HCG Clinical/Analytical Sensitivity: 25mIU/mL.
Device Description: CB8 PL Digital Pregnancy Stick CVS DPS Yes/No Digital
FDA Document #: K060128.
Manufacturer: Unipath, LTD.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428436288.

CVS Early Result Pregnancy Test (Red Box) – CVS Health

Alternate Name: Early Result Pregnancy Test.
Alternate Name: PLPL CVS SPS Early Result.

Alternate Name: Fact plus®& One-Step Pregnancy Test
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

HCG Cut Off Sensitivity (Early Result): Unknown.
HCG Clinical/Analytical Sensitivity (Early Result): 25mIU/mL.
HCG Cut Off Sensitivity (Digital): 9-10 mIU/mL.
HCG Clinical/Analytical Sensitivity (Digital): 25mIU/mL.

Device Description: PLPL CVS SPS Early Result
FDA Document #: K042280
Distributor: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Manufacturer: Inverness Medical, LLC, Waltham, MA

Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428323649.
More Information & Directions: https://cpg-health.com/how-accurate-is-cvs-early-result-pregnancy-test/

CVS Early Pregnancy Test (Green Box) – CVS Health

UPC: 050428310680

CVS One Step Pregnancy Test (Blue Box) – CVS Health

Alternate Name: CVS Health One Step Pregnancy Test
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

HCG Cut Off Sensitivity: Unknown.HCG Clinical/Analytical Sensitivity: 25mIU/mL.
HCG Cut Off Sensitivity (Early Result): Unknown.
HCG Clinical/Analytical Sensitivity (Early Result): 25mIU/mL.
HCG Cut Off Sensitivity (Digital): 9-10 mIU/mL.
HCG Clinical/Analytical Sensitivity (Digital): 25mIU/mL.

Device Description: One Step Pregnancy Test.
FDA Document #: K042280.
Manufacturer: Unipath, LTD., Now known as SPD Swiss Protection Diagnostics GmbH.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00050428422991

DG Health One Step Pregnancy Test (Dollar General)

HCG Cut Off Sensitivity: Unknown
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.
FDA Document #K012215 and #K032661.
Manufacturer:
Access GUDID URL:

e.p.t.® Analog Pregnancy Test

HCG Cutoff Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
AccessGUDID URL:

Get e.p.t.® Analog Pregnancy Test

e.p.t.® Home Pregnancy Test Direct Flow hCG with European Technology

HCG Cutoff Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Distributor:
Manufacturer:
AccessGUDID URL:

Get e.p.t.® Home Pregnancy Test Direct Flow hCG with European Technology

Equate Digital Pregnancy Test

HCG Cut Off: 9 to 10 mIU/mL.
HCG Clinical/Analytical Sensitivity: 25 mIU/mL
FDA Document #K060128.
Distributor:
Manufacturer:
Access GUDID URL:

Equate Early Result Pregnancy Test (Walmart Equate SPS Early Result)

HCG Cut Off Sensitivity:
Clinical/Analytical Sensitivity:
FDA Document #K042280
Distributor:
Manufacturer:
Acesss GUDID URL: https://accessgudid.nlm.nih.gov/devices/00681131249409

Equate Early Result Pregnancy Test Instructions.

NOTE 1: FDA grants approval to this and many similar devices (including +/- tests, test cassetes, and two-line test sticks) under the same approval document. Sadly, the document itself, K042280, does not contain much product information.
NOTE 2: This device is identical to the Rite Aid Pregnancy Test (Early Result).

Equate First Signal One Step Pregnancy Test

Cut Off: Unknown.
Clinical/Analytical: 25 mIU/mL.
FDA Document #K042280, K012215
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00751774356113
NOTES: Device identical to: Dollar General One Step Pregnancy Test Cassette.

Equate One Step Pregnancy Test

HCG Cut Off Sensitivity: Unknown.
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.
FDA Document #K042280.
Distributor:
Manufacturer:

Equate One Step Pregnancy Test Instructions.

NOTE 01: Device is identical to: Rexall One Step Pregnancy Test.
NOTE 02: FDA grants approval to this and many similar devices (including +/- tests and two-line tests) under the same approval document. Sadly, the document itself, K042280, does not contain much product information.

Equate Triple Test Pregnancy Test Kit

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #K042280, K060128.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00681131240802
NOTES: Product contains three different pregnancy tests: 1 Equate One Step Pregnancy Test, 1 Equate Early Result Pregnancy Test and 1 Equate Digital Yes+ No- Pregnancy Test

Family Wellness Early Result Pregnancy Test

Alternate Name: Family Dollar Pregnancy Test.
Alternate Name: Early Result Pregnancy Test.
Alternate Name: Wondfo One Step HCG Urine Pregnancy Test.

Device Equivalence (Compare To): First Response.

HCG Cut Off Sensitivity: 8 mIU/mL.
HCG Clinical/Analytical Sensitivity: 10 mIU/mL.
FDA Document #K150022.
Distributor: FOURSTAR GROUP INC.
Manufacturer: GUANGZHOU WONDFO BIOTECH CO., LTD.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00032251057663.

Family Wellness Pregnancy Test instructions.

Get the Family Dollar Pregnancy Test.

FIRST RESPONSE Comfort Check Pregnancy Test

Get First Response Comfort Check Pregnancy Test.

First Response Digital Pregnancy Test

HCG Cut Off: 6 mIU/mL
HCG Clinical / Analytical Sensitivity: 10 mIU/mL
FDA Document #K123436.
Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer:
Access GUDID URL:

Get First Response Digital Pregnancy Test.

First Response Early Result Pregnancy Test (FRER)

HCG Cut Off: 6 mIU/mL
HCG Clinical / Analytical Sensitivity: 10 mIU/mL
FDA Document #K123436.
Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer:
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00022600020141

Get First Response Early Result Pregnancy Test (FRER).

First Response Ovulation Predictor

FDA Document #K973310
Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer: ARMKEL, LLC.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00022600900542

Get First Response Ovulation Predictor.

First Response Rapid Result Pregnancy Test

HCG Cut Off: 6 mIU/mL
HCG Clinical / Analytical Sensitivity: 10 mIU/mL
FDA Document #
Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer:
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00061700900700

Get First Response Rapid Result Pregnancy Test.

First Response Test and Confirm Pregnancy Test

HCG Cut Off Sensitivity, HCG Clinical / Analytical Sensitivity, FDA Document #:

See records for:

First Response Early Result Pregnancy Test.
First Response Digital Pregnancy Test.

Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer:
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00022600901334

Get First Response Test and Confirm Pregnancy Test.

First Response Triple Check Pregnancy Test Kit

HCG Cut Off Sensitivity, HCG Clinical / Analytical Sensitivity,:

See records for:

First Response Early Result Pregnancy Test.
First Response Digital Pregnancy Test.
First Response Rapid Result Pregnancy Test.

FDA Document #K123436, K123567, K973352.
Distributor: CHURCH & DWIGHT CO., INC.
Manufacturer:
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00061700900700

Get First Response Triple Check Pregnancy Test Kit.

Heal-Check Pregnancy Test Strips

Get a great deal on Heal-Check Pregnancy Test Strips from Amazon,

New Choice One Step Pregnancy Test (Cassette)

HCG Cut Off sensitivity: 25 mIU/mL
HCG Clinical/Analytical sensitivity: 50 mIU/ML
FDA Document #K043443.
Manufacturer:
Access GUDID URL:

New Choice Plus One Step Pregnancy Test (Midstream)

HCG Cut Off sensitivity: 25 mIU/mL
HCG Clinical sensitivity: 50 mIU/mL
FDA Document #K043443
Manufacturer:
Access GUDID URL:

New Choice Plus One Step Pregnancy Test Instructions.

Paraid Pregnancy Test (aka, Para-Aid)

Alternate Name: PARAID – 06937579912134
Alternate Name: EGENS One Step HCG Urine Pregnancy Test Kit.
Alternate Name: Personal Care 1 Step Pregnancy Test.

HCG Cut Off Sensitivity: 25 mIU/mL
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.
FDA Document #K123050
Distributor: NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
Manufacturer: NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/06937579912134

Paraid Pregnancy Test Instructions.

Personal Care 1 Step Pregnancy Test (Compare to e.p.t.)

Alternate Name: Personal Care – 00048155920200.
Alternate Name: EGENS One Step HCG Urine Pregnancy Test Kit.
Alternate Name: Paraid Pregnancy Test / Para-Aid Pregnancy Test.

HCG Cut Off Sensitivity: 25 mIU/mL
HCG Clinical/Analytical Sensitivity: 25 mIU/mL.
FDA Document #K123050
Distributor: Delta Brands Inc.
Manufacturer:
AccessGUDID URL: https://accessgudid.nlm.nih.gov/devices/00048155920200

Get the Personal Care 1 Step Pregnancy Test.

Preview Early Result Pregnancy Test

HCG Cut Off Sensitivity: 8 mIU/mL
HCG Clinical/Analytical Sensitivity: 10 mIU/mL
FDA Document #K150022.
Manufacturer: Wondfo
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00864112000200

Rexall One Step Pregnancy Test

HCG Cut Off Sensitivity: Unknown.
HCG Clinical/Analytical Sensitivity: 25 mIU/mL
FDA Document #K042280 and K990373.
Manufacturer: SPD Diagnostics / Inverness Medical / Abbot / Alere
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00430000702084

Rexall Pregnancy Test Instrucitons.

Rite Aid Family Planning Early Result Pregnancy Test

Alternate Name: Family Planning Pregnancy Test Early Result
Alternate Name: Fact Plus One Step Pregnancy Test Kit

HCG Cut Off Sensitivity: Unknown
HCG Clinical/Analytical Sensitivity: 25mIU/mL
FDA Document #K042280
Manufacturer: SPD Swiss Precision Diagnostics GMBH.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00011822473033

NOTE: This test is identical to many other devices sold under different brands. For example, SPD Diagnostics also packages this device as Walmart’s Equate Early Result Pregnancy Test.

Rite Aid Family Planning One Step Pregnancy Test

Alternate Name: FPPL Rite Aid TPS +/- (ER)
Alternate Name: Fact Plus One Step Pregnancy Test Kit

up & up™ Advanced Early Result Pregnancy Test Target

Alternate Name: Target DPS Advanced Early Result Pink Cap
Alternate Name: Fact Plus One-Step Pregnancy Test Kit.

HCG Cut Off Sensitivity: Unknown.
HCG Clinical/Analytical Sensitivity: 25mIU/mL
FDA Document #K042280.
Manufacturer: SPD Diagnostics / UniPath / Abbott
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00751774733532

up & up™ One Step Pregnancy Test Target (Compare to e.p.t)

Alternate Name: FPPL Target DPS +/- (ER)

NOTE 1: As of April 30, 2017, this Target/up&up product is no longer available for sale.
NOTE 2: You can buy the identical test device packaged as the up&up One Step Pregnancy Test packaged under different brands marketed under the same FDA decision document (K042280).

HCG Cut Off Sensitivity: 25 mIU/mL.
HCG Clinical/Analytical Sensitivity: 25 mIU/mL
FDA Document #K042280
Distributor: Inverness Medical, LLC / Target Corporation
Manufacturer: Abbott (Now part of SPD Diagnostics).
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00492450302887

VeriQuick

HCG Cut Off Sensitivity: 25 mIU/mL
HCG Clinical Sensitivity: 35 mIU/mL
FDA Document #K123703 and K103574.
Manufacturer: HEALGEN SCIENTIFIC, LLC
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00049696736657

VeriQuick Pregnancy Test Instructions.