The FIRST RESPONSE " Gold Digital 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.

Device Description

The FIRST RESPONSE™ Gold™ Digital 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 as early as six (6) days before the day of the missed period. The detection of hCG in the urine of a pregnant woman is accomplished by a series of immunochemical reactions via component reagents that are deposited onto a chromatographic strip contained within a plastic housing. A digital component integral with the chromatographic strip reads and displays the result of the immunochemical reaction on an LCD (Liquid Crystal Display) screen of the device in place of the colored lines of the predicate device. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip of the device into the urine stream for 5 seconds (or alternatively by fully immersing the collection tip for 5 seconds in a urine sample that was collected in a cup). A clock symbol will begin to blink in about 30 seconds after the urine is applied to indicate to the consumer that the test is working. The test result is read on the LCD screen of the device within 3 minutes. A "YES+" test result indicates that the pregnancy hormone (hCG) was detected (pregnant) and a "NO-" test result indicates that no hCG was detected (not pregnant).

AI/ML Overview

This document describes the 510(k) summary for the FIRST RESPONSE™ Gold™ Digital Pregnancy Test. While it thoroughly outlines various studies conducted to demonstrate substantial equivalence, it does not present a formal table of "acceptance criteria" with explicit quantitative targets that the device was required to meet for each performance metric. Instead, the document describes a series of studies designed to show performance comparable to the predicate device or to establish key analytical characteristics.

Therefore, the response below will interpret "acceptance criteria" based on the nature of the studies performed and the conclusions drawn in the document, acknowledging that explicit numerical acceptance targets are not formally presented in a table format in the provided text. The "reported device performance" will be derived from the specific findings mentioned for each study.

Device: FIRST RESPONSE™ Gold™ Digital Pregnancy Test

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria with specific numerical targets are not formally presented in a table in the provided document, the "acceptance criteria" are inferred from the stated purpose of each study and the conclusion of substantial equivalence. "Reported device performance" is derived from the study outcomes described.

Performance Metric (Inferred Acceptance Criterion)	Reported Device Performance
Accuracy (vs. Predicate Device): Demonstrate no discrepancies in accuracy compared to the predicate device using quantified hCG urine samples.	Status: Met. "The study showed no discrepancies in accuracy."
Analytical Sensitivity: Achieve a specified analytical sensitivity (e.g., 10 mIU/mL).	Status: Met. "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."
Lay User Performance: Demonstrate no difference in device performance between lay users and laboratory professionals.	Status: Met. "The data demonstrate no difference in device performance between lay users and laboratory professionals."
Intra and Inter-lot Precision: Demonstrate no significant intra or inter lot-to-lot variability using hCG standards.	Status: Met. "The data demonstrate no intra nor inter lot-to-lot variability."
Interfering Substances & Homologous Hormones: Demonstrate no effect on performance when challenged with potential interfering substances and homologous hormones.	Status: Met. "The data demonstrate no effect on the performance of the device."
High Dose Hook Effect: Demonstrate no high dose hook effect when challenged with very high levels of intact hCG.	Status: Met. "The data demonstrate no effect on the performance of the device."
hCG Beta Core Fragment (hCG ßcf): Confirm no detrimental effect on performance from high levels of hCG ßcf.	Status: Met. "The results of this study show no detrimental effect on the performance of the device."
Early Pregnancy Detection: Demonstrate ability to detect hCG days before the missed period (specifically 6 days).	Status: Met. "The data demonstrate that the device can detect hCG 6 days before the missed period." The intended use also states detection 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.
False Positive Rate (Pre/Peri/Post-menopausal Women): Demonstrate zero potential for false positive results in pre-, peri-, and post-menopausal women.	Status: Met. "The data demonstrate that the potential for false positive results in the subpopulations is zero."
Consumer Self-Use & Interpretation: Demonstrate that consumers can perform the test and interpret the results correctly.	Status: Met. "The data demonstrate that consumers can perform the test and interpret the result correctly."

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

The document details multiple laboratory and consumer studies but does not specify the exact sample sizes (number of individuals or urine samples) used for each test set. It mentions the use of "urine samples quantified for hCG levels from pregnant and non-pregnant women" and "hCG standards of known concentration" for laboratory studies, and "lay users" for consumer studies.

Provenance: The document does not explicitly state the country of origin for the data. Given it's an FDA 510(k) submission, it's typically assumed to be U.S.-centric or globally sourced data acceptable to FDA. The studies appear to be prospective in nature, involving testing new samples with the device, especially the consumer studies and early pregnancy detection study (using conceptive cycles).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions "laboratory professionals" for comparison with lay users and the use of "urine samples quantified for hCG levels." This implies an existing, validated reference method for hCG quantification (e.g., a laboratory immunoassay) was used to establish the ground truth for hCG levels.

Number of Experts: Not specified.
Qualifications of Experts: Implied medical/laboratory professionals capable of performing quantitative hCG assays and clinical interpretation. (e.g., Clinical Laboratory Scientists, Medical Technologists). No specific board certifications or years of experience are listed.

4. Adjudication Method for the Test Set

The document does not describe a formal multi-reader or adjudication process (e.g., 2+1, 3+1) for establishing ground truth, as it's a diagnostic test for a chemical analyte (hCG). Ground truth for hCG levels would typically be established by a quantitative reference assay, not by expert consensus reading of images or similar subjective interpretations. For the consumer studies, the ground truth was likely the quantitative hCG level of the sample and/or the result from the laboratory professional.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is a standalone in-vitro diagnostic (IVD) pregnancy test, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies. The "digital component" is described as reading and displaying the result of the immunochemical reaction, replacing subjective reading of lines with a clear "YES+" or "NO-".
Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported. The "digital component" serves as an automated reader for the immunoassay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a form of standalone performance was implicitly done. The device's "digital component integral with the chromatographic strip reads and displays the result... an optimized algorithm capable of determining and correctly interpreting the assay result and displaying a simple "YES+" or "NO-"." The laboratory studies evaluating analytical sensitivity, accuracy against quantified samples, precision, and interference are essentially evaluating the "algorithm only" performance of the digital system in interpreting the immunoassay reaction.
The "consumer self-use study" confirms the user's ability to perform the test and interpret the digital result, but the core "reading" is done by the device's internal algorithm.

7. Type of Ground Truth Used

The primary ground truth used for the analytical and clinical performance studies was quantitative human chorionic gonadotropin (hCG) levels in urine samples. These levels were "quantified for hCG" using a reference method.
For the early pregnancy detection study, the ground truth was tied to the woman's conceptive cycle and the number of days before the missed period, correlating with the presence and quantifiable levels of hCG at those specific time points.
For the consumer studies, the ground truth was likely the known hCG status of the urine sample (pregnant/non-pregnant based on quantitative levels) and the interpretation provided by the "laboratory professionals" for comparison.

8. Sample Size for the Training Set

The document does not specify a separate training set size. The description focuses on verification and validation studies to demonstrate substantial equivalence. For IVDs, "training" might refer to the development and optimization of the internal algorithm/optical components during the design phase. The data used for the performance studies described are typically considered the 'test set' for validation to support market clearance.

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

Since a distinct "training set" isn't explicitly described or quantified, the method for establishing its ground truth is not detailed. However, if one assumes an internal optimization/development phase for the "optimized algorithm," the ground truth would similarly have been established using quantified hCG urine samples and possibly other defined standards to teach the algorithm to accurately interpret the immunochemical reaction and display the correct "YES+" or "NO-" result. This process would occur prior to the formal validation studies.

Summary

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K/23567

510(k) SUMMARY

SEP 1 0 2013

Submitted by:

Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543

Contact Person:

Date Prepared:

Common Name:

Joseph Ciccone, Senior Regulatory Manager, Regulatory Affairs

September 9, 2013

FIRST RESPONSE™ Gold™ Digital Pregnancy Test Proprietary Name:

At-home Pregnancy Test

Classification Name: Human chorionic gonadotropin (hCG) test system [21 CFR §862.1155] 75 LCX; Class II

FIRST RESPONSE™ Early Result Pregnancy Test Predicate Device: 510(k) #K083716

Description of Device:

Intended Use of the Device: The FIRST RESPONSE™ Gold™ Digital Pregnancy Test is a single-use in vitro diagnostic test device intended for the early detection of pregnancy by the lay user. The test detects human chorionic gonadotropin (hCG) hormone in urine. The device is indicated for use as early as five (5) days before the day of expected period, i.e., as early as six (6) days before the day of the missed period.

Technological Characteristics: The 510(k)-subject FIRST RESPONSE™ Gold™ Digital Pregnancy Test device and its analog predictate counterpart utilize identical immunochemical principles for the determination of hCG. They differ in that the reagent system of the 510(k)-subject device has been enhanced 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 for also prevents or reduces the potential for a false negative test result because hCG ßcf is the major form of immunoreactive

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urinary hCG commonly found in later pregnancy (2, 3). In addition, the subject 510(k) device differs from the predicate device in that it provides a digital display of test result for the consumer to read in place of the colored lines of the predicate device. The digital version of the predicate device incorporates into the device housing electronic and optical components along with a microprocessor and an optimized algorithm capale of determining and correctly interpreting the assay result and displaying a simple "YES+" or "NO-" on the LCD screen. The digital device which is battery powered will display the result for at least thirty minutes after completion of the reaction. All components are integrated and unitized into the device housing.

( S

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 no difference in 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 confirm high levels of hCG Bcf. 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 days 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 zero.

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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.
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:

1. McChesney R, Wilcox AJ, O'Connor JF, Weinberg CR, Baird DD, Schlatterer JP, 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.
1. Gronowski A, Cervinski M, Stenman UH, Woodworth A, Ashby L, Scott MG. Falsenegative results in point-of-care qualitative human chorionic gonadotropin (hCG) devices due to excess hCGB core fragment. Clin Chem 2009; 55:7; 1389-1394.
1. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a wave or flame. The logo is printed in black and white.

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2013

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

Re: K123567

Trade/Device Name: FIRST RESPONSE™ Gold™ Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: September 3, 2013 Received: September 4, 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 docs 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 cither 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 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 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 go to hun://www.fda.gov://thoutf1)//CentersOffices/CDRF//CDRHOffices/ucm115809.htm 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/McdicalDcvices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

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): K123567

FIRST RESPONSE™ Gold Digital Pregnancy Test Device Name:

Indications for Use:

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 re-test again a few days after your missed period.

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

2013.09.10 07:34:34 -04'00'

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

K123567 510(k)

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.