The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period). This test is only intended for individual use at home. It is not intended for use in a healthcare setting.

Device Description

The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine 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 collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).

AI/ML Overview

The provided document describes the FIRST RESPONSE® Early Result Pregnancy Test, an at-home pregnancy test that detects human chorionic gonadotropin (hCG) in urine. The key focus of the submission is a modification to the device to achieve increased analytical and clinical sensitivity, allowing for earlier detection of pregnancy (6 days before the missed period, compared to 5 days for the predicate device).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, the primary acceptance criterion inferred from the submission is the ability of the device to detect hCG as early as 6 days before the missed period both analytically and when interpreted by consumers. The reported device performance is that it achieves this increased sensitivity and consumers can accurately read and interpret the results at this earlier time point.

Acceptance Criteria (Inferred)	Reported Device Performance
Analytical Sensitivity: Increased detection capability to identify hCG at levels present 6 days before the missed period.	The device uses a different size gold particle and modified streptavidin to achieve an increased analytical sensitivity, allowing detection of hCG earlier in pregnancy (6 days before the missed period).
Clinical Sensitivity/Usability: Consumers can accurately read and interpret results from early pregnancy urines 6 days before the missed period.	A consumer study confirmed professional testing and verified the device performance characteristics with early pregnancy urines, demonstrating that the results of the test can be accurately read and interpreted by consumers as early as 6 days before the missed period. The labeling claim and directions for use were modified accordingly.
Substantial Equivalence: Maintain substantial equivalence to the predicate device despite modifications.	The FDA determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions a "consumer study" and "professional testing" to verify device performance. However, it does not specify the sample size used for the test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective data collection, as it's a study designed to verify the performance of the modified device with "early pregnancy urines."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states, "A consumer study confirmed professional testing and verified the device performance characteristics..." This implies that "professional testing" established a ground truth against which consumer results were compared. However, the number of experts and their specific qualifications (e.g., medical professionals, lab technicians, etc.) are not provided.

4. Adjudication Method for the Test Set

The document mentions "professional testing" and a "consumer study," indicating a comparison. However, the specific adjudication method (e.g., 2+1, 3+1, none) for the test set is not described. It can be inferred that the professional testing results served as a reference or a form of adjudicated truth for the consumer study, but the methodology of this adjucation is absent.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study described focuses on consumer interpretation of the device's results, not a comparison of human readers' performance with and without AI assistance. The device itself is an in-vitro diagnostic test, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is an at-home pregnancy test, meaning the "algorithm" (the immunochemical reactions on the strip) performs standalone, and the consumer then interprets the visual result (one or two lines). The "consumer study" specifically evaluates the human interpretation aspect. Therefore, a standalone performance of the immunochemical test (the core of the "algorithm") is implicitly what "professional testing" would assess, and the consumer study then assesses the human interpretation of that standalone output. The document does not explicitly present data from an "algorithm only" study in isolation from any human interpretation, but the entire device functions in a standalone manner before human interpretation.

7. The Type of Ground Truth Used

The ground truth for the "consumer study" was established through "professional testing" using "early pregnancy urines." This implies that the presence and concentration of hCG in these urine samples were independently verified and quantified by professional laboratory methods, serving as the objective ground truth for pregnancy status.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The description indicates a modification to an existing device (predicate device) and subsequent verification studies (professional testing and a consumer study) for the modified device. There is no indication of a machine learning model being trained, which would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of a machine learning model, this information is not applicable and not provided. The studies described are for verification of the modified device's performance.

Summary

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683716

510(k) Summary

Submitted by:	Church & Dwight Co., Inc.469 North Harrison StreetPrinceton, NJ 08543	JUN - 8 2009
Contact Person:	Stephen C. KolakowskyDirector, Regulatory Affairs
Date Prepared:	December 12, 2008; Revised June 5, 2009
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) #K030258 and#K992232

Description of Device: The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine 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 collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).

Intended Use of the Device: The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period).

This test is only intended for individual use at home. It is not intended for use in a healthcare setting.

Important note regarding negative results:

Some pregnant women will not be able to detect hCG in their urine 6 days before the missed period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period.

Important note regarding positive results:

Because this test detects very low levels of hCG, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.

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

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Technological Characteristics: The modified 510(k)-subject device does not represent a change in technology, only an enhancement, and thus is substantially equivalent to the predicate device. The 510(k)-subject device and the predicate device are essentially identical. They differ in that the 510(k)-subject device has been modified to use a different size gold particle and a modified streptavidin to achieve an increased analytical and clinical sensitivity, and thus, the ability to detect the presence of hCG earlier in pregnancy, viz., six (6) days rather than five (5) days before the day of the missed period. The labeling claim and directions for use relative to the time of use prior to the expected period that the test may be used have been correspondingly modified. A consumer study confirmed professional testing and verified the device performance characteristics with early pregnancy urines demonstrating that the results of the test can be accurately read and interpreted by consumers as early as 6 days before the missed period. The device housing has also been modified to be more user-friendly.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Church & Dwight Co., Inc. c/o Stephen C. Kolakowsky, Director Regulatory Affairs 469 North Harrison Street Princeton, NJ 08543

JUN - 8 2009

Re: K083716

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: Class II Product Code: LCX Dated: April 23, 2009 Received: April 24, 2009

Dear Mr. Kolakowsky:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 that 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A.C.H.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K083716

Device Name: FIRST RESPONSE® Early Result Pregnancy Test

Indication For Use:

The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCC), in some cases, as early as 6 days before the missed period (5 days before the expected period).

This test is only intended for individual use at home. It is not in a healthcare setting.

Important note regarding negative results:

Important note regarding positive results:

Because this test detects very low levels of hCC, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.

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 Diagnostic Device Evaluation and Safety (OIVD)

Signature

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083716

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.