The FIRST RESPONSE™ Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Important note regarding negative results:

Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.

All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Device Description

The FIRST RESPONSE™ Early Result Pregnancy Test is a test system for the detection of human chorionic gonadotropin (hCG) hormone. Specifically, it is a screening device intended for the early detection of pregnancy by the lay user through the qualitative detection of hCG in urine, in some cases as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent pad of the device into the urine stream for 5 seconds (or alternatively by fully immersing the absorbent pad for 5 seconds in a urine sample that was collected in a cup). The test result is displayed at the housing window for reading by the layer user after the elapse of 3 minutes. Two pink lines indicate that hCG has been detected (pregnant); one pink line indicates that no hCG has been detected (not pregnant).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FIRST RESPONSE™ Early Result Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for this device is "substantial equivalence" to the predicate device, specifically in its ability to detect pregnancy early (as early as 6 days before the missed period). The studies below collectively demonstrate this substantial equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Accuracy compared to predicate device using pregnant and non-pregnant urine samples.	"The study showed no discrepancies in accuracy" compared to the predicate device.
Analytical sensitivity of hCG detection.	Analytical sensitivity is 10 mIU/mL with a 50/50 cutoff of 6 mIU/mL for both midstream and dip methods.
Ability of lay users to obtain similar results around sensitivity and cutoff as laboratory professionals.	"The data demonstrate similar device performance between lay users and laboratory professionals."
Intra- and inter-lot precision.	"The data demonstrate no intra nor inter lot-to-lot variability."
Performance unaffected by potential interfering substances and homologous hormones.	"The data demonstrate no effect on the performance of the device."
Performance unaffected by high dose hook effect (very high levels of intact hCG).	"The data demonstrate no effect on the performance of the device."
Performance unaffected by high levels of hCG ßcf.	"The results of this study show no detrimental effect on the performance of the device."
Ability to detect hCG days before the missed period in conceptive cycles.	"The data demonstrate that the device can detect hCG 6 days before the missed period." This directly supports the "early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period" claim.
Negligible potential for false positive results in pre-, peri-, and post-menopausal women due to quantified hCG urine samples.	"The data demonstrate that the potential for false positive results in the subpopulations is negligible."
Ability of consumers to perform the test and interpret results correctly.	"The data demonstrate that consumers can perform the test and interpret the result correctly." This relates to the device's intended use as an over-the-counter and "lay user" product.

Study Information

The document describes several studies conducted to demonstrate the substantial equivalence of the modified FIRST RESPONSE™ Early Result Pregnancy Test.

1. A laboratory study to demonstrate the accuracy of the 510(k)-subject device compared to the accuracy of the predicate device.

Sample size for the test set: Not specified.
Data provenance: Urine samples quantified for hCG levels from pregnant and non-pregnant women. Implied to be retrospective lab samples, potentially from a collection of known states. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "urine samples quantified for hCG levels" implies a lab standard, not expert consensus for ground truth.
Adjudication method: Not applicable, as ground truth is based on quantitative hCG levels.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this was a comparative accuracy study against a predicate device.
Standalone (algorithm only) performance: Yes, this appears to be a standalone performance evaluation against quantifiable samples.
Type of ground truth used: Quantitative hCG levels in urine samples.
Sample size for the training set: Not applicable, this is a performance evaluation, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

2. A laboratory study to determine the analytical sensitivity and cut-off of the 510(k)-subject device.

Sample size for the test set: Not specified.
Data provenance: Uses "hCG standards of known concentration." This implies controlled laboratory samples. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
Type of ground truth used: Known concentrations of hCG standards.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

3. A consumer study to demonstrate the ability of lay users to obtain similar results around the established sensitivity and cutoff as laboratory professionals.

Sample size for the test set: Not specified, but involves "lay users" and "laboratory professionals."
Data provenance: Implied to be prospective, involving actual users performing the test. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Laboratory professionals are part of the comparison, so they establish a reference, but not necessarily a "ground truth" in the diagnostic sense beyond comparing performance. The inherent ground truth would still be the hCG levels of the samples being tested.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this is a comparison of performance between user groups.
Standalone (algorithm only) performance: No, this study involves human-in-the-loop (lay users and professionals).
Type of ground truth used: Implicitly, the hCG levels of the samples used. The "ground truth" here is less about the state of pregnancy and more about whether different user groups get the same test outcome on the same sample.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

4. A laboratory study to assess intra and inter lot precision of the 510(k)-subject device.

Sample size for the test set: Not specified.
Data provenance: Uses "hCG standards of known concentration." Implied controlled laboratory samples. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
Type of ground truth used: Known concentrations of hCG standards.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

5. Laboratory studies to demonstrate that potential interfering substances and homologous hormones do not affect the performance.

Sample size for the test set: Not specified.
Data provenance: Controlled laboratory conditions with added interfering substances and homologous hormones. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
Type of ground truth used: Expected negative or positive results in the presence of various substances based on known hCG levels in test samples.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

6. A laboratory study to demonstrate that no high dose hook effect is observed.

Sample size for the test set: Not specified.
Data provenance: Controlled laboratory conditions using "very high levels of intact hCG." Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
Type of ground truth used: Known very high concentrations of hCG, with the expectation of a positive result.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

7. A laboratory study to determine the effect of high levels of hCG ßcf on device performance.

Sample size for the test set: Not specified.
Data provenance: Controlled laboratory conditions. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone analytical performance study.
Type of ground truth used: Known hCG levels in the presence of high hCG ßcf.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

8. An early pregnancy detection study using urine samples from conceptive cycles.

Sample size for the test set: Not specified.
Data provenance: Urine samples from conceptive cycles. Implied prospective collection to track early pregnancy onset. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "conceptive cycles" suggests tracking women attempting to conceive, with pregnancy confirmation likely through clinical methods (blood tests, ultrasound) as the ground truth.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this evaluates the device's standalone ability to detect hCG early.
Type of ground truth used: Confirmed pregnancy status from conceptive cycles, likely through clinical gold standards.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

9. A laboratory study to determine the performance with urine samples quantified for hCG from pre-, peri-, and post-menopausal women.

Sample size for the test set: Not specified.
Data provenance: Urine samples from pre-, peri-, and post-menopausal women, quantified for hCG. Implied retrospective lab samples. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not specified, but "urine samples quantified for hCG" implies a lab standard for ground truth.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: Yes, this is a standalone performance evaluation against quantifiable samples.
Type of ground truth used: Quantitative hCG levels and menopausal status.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

10. A consumer self-use study to determine the ability of the consumers to perform the test and interpret the results correctly.

Sample size for the test set: Not specified, but involves "consumers."
Data provenance: Implied prospective, involving actual consumers performing the test. Country of origin not specified.
Number of experts used to establish the ground truth for the test set and qualifications: Not specified. Ground truth for correct interpretation would likely involve comparing consumer interpretation to an objective standard (e.g., a lab professional's read of the same test, or the known hCG status of the sample).
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No.
Standalone (algorithm only) performance: No, this study involves human-in-the-loop (consumers).
Type of ground truth used: The actual result shown on the strip and whether the consumer's interpretation matches it. The underlying ground truth of pregnancy for the samples would also be relevant.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of missing information:

Specific sample sizes for most of the test sets.
Country of origin for the data.
Specific qualifications and number of experts for establishing ground truth, especially for the "conceptive cycles" study and the consumer interpretation study.
Detailed methodology for ground truth establishment beyond "quantified hCG levels" or "conceptive cycles."
Any training set information, as these are primarily performance evaluation studies for a diagnostic device, not a machine learning algorithm.

Summary

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K123436

AUG 2 6 2013

510(k) SUMMARY

Submitted by:	Church & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543
Contact Person:	Joseph Ciccone, Senior Manager, Regulatory Affairs
Date Prepared:	August 26, 2013
Proprietary Name:	FIRST RESPONSE™ Early Result Pregnancy Test
Common Name:	At-home Pregnancy Test
Classification Name:	Human chorionic gonadotropin (hCG) test system[21 CFR §862.1155] 75 LCX; Class II
Predicate Device:	FIRST RESPONSE™ Early Result Pregnancy Test510(k) #K083716

Description of Device: The FIRST RESPONSE™ Early Result Pregnancy Test is a test system for the detection of human chorionic gonadotropin (hCG) hormone. Specifically, it is a screening device intended for the early detection of pregnancy by the lay user through the qualitative detection of hCG in urine, in some cases as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent pad of the device into the urine stream for 5 seconds (or alternatively by fully immersing the absorbent pad for 5 seconds in a urine sample that was collected in a cup). The test result is displayed at the housing window for reading by the layer user after the elapse of 3 minutes. Two pink lines indicate that hCG has been detected (pregnant); one pink line indicates that no hCG has been detected (not pregnant).

Intended Use of the Device: The FIRST RESPONSE™ Early Result Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Important note regarding negative results:

Important note regarding positive results:

All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Technological Characteristics: The 510(k)-subject FIRST RESPONSE™ Early Pregnancy Test does not represent a change in fundamental technology from the predicate FIRST RESPONSE™ Early Result Pregnancy Test device (510(k) K083716), only modifications

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thereto. They are substantially equivalent. Both devices utilize the identical immunochemical principles for the detection of hCG. They differ in that the 510(k)subject device has been modified to include an additional monoclonal antibody capable of detecting hCG beta core fragment (hCG ßcf). hCG ßcf is produced in early pregnancy (1) and its detection is intended to improve the clinical performance of the device. Detection of hCG Bcf also prevents or reduces the potential for a false negative test result because hCG ßcf is the major form of immunoreactive urinary hCG commonly found in later pregnancy (2, 3).

ﮐﮯ

A number of laboratory and consumer use studies were undertaken to demonstrate that the 510K-subject device is substantially equivalent to the predicate device for the detection of pregnancy as early as 6 days before the day of missed period. These studies are as follows:

. A laboratory study to demonstrate the accuracy of the 510(k)-subject device compared to the accuracy of the predicate device using urine samples quantified for hCG levels from pregnant and non-pregnant women. The study showed no discrepancies in accuracy.
. A laboratory study to determine the analytical sensitivity and cut-off of the 510(k)subject device using hCG standards of known concentration. The data demonstrate that the analytical sensitivity is 10 mIU/mL with a 50/50 cutoff of 6 mIU/mL for both midstream and dip method.
. A consumer study to demonstrate the ability of lay users to obtain similar results around the established sensitivity and cutoff as laboratory professionals. The data demonstrate similar device performance between lay users and laboratory professionals.
. A laboratory study to assess intra and inter lot precision of the 510(k)-subject device using hCG standards of known concentration. The data demonstrate no intra nor inter lot-to-lot variability.
. Laboratory studies to demonstrate that potential interfering substances and homologous hormones do not affect the performance of the 510(k)-subject device. The data demonstrate no effect on the performance of the device.
. A laboratory study to demonstrate that no high dose hook effect is observed when the 510(k)-subject is challenged with very high levels of intact hCG. The data demonstrate no effect on the performance of the device.
A laboratory study to determine the effect of high levels of hCG ßcf on device . performance. The results of this study show no detrimental effect on the performance of the device.
. An early pregnancy detection study using urine samples from conceptive cycles to demonstrate that the 510(k)-subject device can detect hCG days before the missed period. The data demonstrate that the device can detect hCG 6 daýs before the missed period.
A laboratory study to determine the performance of the 510(k)-subject device with . urine samples quantified for hCG from pre-, peri-, and post-menopausal women. The data demonstrate that the potential for false positive results in the subpopulations is negligible.

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A consumer self-use study to determine the ability of the consumers to perform the . test and interpret the results correctly. The data demonstrate that consumers can perform the test and interpret the result correctly.
Conclusion: The results of the above listed studies demonstrate that the 510(k)subject device is substantially equivalent to the currently marketed First Response™ Early Result Pregnancy Test. The device is safe and effective for the intended use.

References:

ﮨﮯ

. .

McChesney R, Wilcox AJ, O'Connor JF, Weinberg CR, Baird DD, Schlatterer JP, 1. et al. Intact hCG, free hCG beta subunit and hCG beta core fragment: longitudinal patterns in urine during early pregnancy. Hum Reprod 2005:20:928-35.

Gronowski A, Cervinski M, Stenman UH, Woodworth A, Ashby L, Scott MG, 2. False-negative results in point-of-care qualitative human chorionic gonadotropin (hCCG) devices due to excess hCGB core fragment. Clin Chem 2009; 55:7; 1389-1394.

Kato Y, Braunstein GD. Beta-core fragment is a major form of immunoreactive urinary chorionic gonadotropin in human pregnancy. J Clin Endocrinol Metab 1988:66: 1197-201.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-Ci609 Silver Spring, MD 20993-0002 August 26, 2013

Church and Dwight Co., Inc. C/O Joseph Ciccone 469 North Harrison St PRINCETON NJ 08543

Re: K123436

Trade/Device Name: FIRST RESPONSE™ Early Result Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: July 30, 2013 Received: August 8, 2013

Dear Mr. Ciccone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean ihat FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you desire spective do not you le mers Offices/CDRH/CDRHOffices/ucm 1 15809.html for

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Page 2-Mr. Ciccone

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias, Ph.D.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123436

FIRST RESPONSE™ Early Result Pregnancy Test Device Name:

Indications for Use:

Important note regarding negative results:

Important note regarding positive results:

All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.08.26 10:42:18 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)____k123436

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.