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.

Pregnancy Test Index

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

Contents
1 Pregnancy Test Index
1.2 CPG Health Pregnancy Test Index

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 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 #K060128
Manufacturer:
Access GUDID URL:

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


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)

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.

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.


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:

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.

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


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

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/00011822510462


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.


Walgreens Digital Pregnancy Test (Compare to Clearblue Digital)

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:


Walgreens Digital Pregnancy Test (Compare to e.p.t. Digital)

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:

Walgreens Digital Pregnancy Test Instructions.


Walgreens Digital & One Step Pregnancy Test (Compare to Clearblue)

Digital

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:

One Step

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:


Walgreens Digital & Early Result Pregnancy Test (Compare to First Response)

Digital

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:

One Step

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:


Walgreens Early Result Analog Pregnancy Test (Compare to First Response)

Alternate Name: TrueDX hCG Early Result Pregnancy Test.
Alternate Name: VeriClear Early Result Pregnancy Test.
Alternate Name: Walgreens One Step Analog.
Alternate Name: Ultra Analog Pregnancy Test

HCG Cut Off Sensitivity: 8.5 mIU/mL
HCG Clinical/Analytical Sensitivity: 10 mIU/mL
FDA Document #K941765 #K172257
Manufacturer: Syntron Bioresearch, Inc.
Access GUDID URL:


Walgreens One Step Analog Pregnancy Test (Compare to e.p.t.)

Alternate Name: One Step Pregnancy Test – 1 Test with Insert.
Alternate Name: TrueDXhCG Early Result Pregnancy Test.
Alternate Name:VeriClear Early Result Pregnancy Test.
Alternate Name: Walgreens Early Result Pregnancy Test.

Cut Off: 8.5 mIU/mL
HCG Clinical/Analytical Sensitivity: 10 mIU/mL.
FDA Document #K172257.
Manufacturer: Syntron.
Access GUDID URL: https://accessgudid.nlm.nih.gov/devices/00311917211213


Walgreens One Step Pregnancy Test +/- (Compare to Clearblue)

HCG Cut Off Sensitivity:
HCG Clinical/Analytical Sensitivity:
FDA Document #
Manufacturer:
Access GUDID URL:

Walgreens One Step Pregnancy Test Instructions.


Learn more at CPG Health

If you think you’re pregnant, you need CPG Health. Potential mothers turn to us to get reliable information about pregnancy tests and pregnancy testing.

Before you go, check out some materials published here at CPG-Health.com: