The Brand Name 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The Brand Name 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as the first day of the missed menses.

Device Description

The Brand Name 1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the "Brand Name 1-Step Pregnancy Test":

1. Acceptance Criteria and Reported Device Performance

The provided document details various performance studies but does not explicitly state numerical acceptance criteria for sensitivity, specificity, or agreement. Instead, it describes general objectives and outcomes. However, it implicitly demonstrates that the device met the criteria for substantial equivalence to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Laboratory Accuracy	Two laboratory studies compared the Brand Name 1-Step Pregnancy Test to the predicate device, First Response® 1-Step Pregnancy Test, to determine its performance.
Sensitivity	A third laboratory study was performed to evaluate and confirm the sensitivity of the Brand Name 1-Step Pregnancy Test.
Lay Consumer Performance	Three separate studies evaluated the ability of consumers to perform and interpret the Brand Name 1-Step Pregnancy Test using both midstream and dip methods.
Substantial Equivalence	The FDA determined the device is substantially equivalent to legally marketed predicate devices, implying that its performance aligns with existing standards for such devices.
Intended Use Fulfillment	The device successfully detects hCG in urine as an aid in the early diagnosis of pregnancy and can be used by lay consumers anytime of the day, as early as the first day of missed menses.

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

The document does not specify the exact sample sizes for the test sets in any of the described studies (laboratory accuracy, sensitivity, or consumer use).

Regarding data provenance, the studies are described as "laboratory studies" and "studies" evaluating consumer ability. Given the context of a 510(k) submission for a new product, these would almost certainly be prospective studies conducted specifically for this submission. The document does not mention the country of origin of the data, but
given the submitter is Carter-Wallace in Cranbury, New Jersey, it is highly probable the
studies were conducted in the United States.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the laboratory studies. For a hCG test, the ground truth for positive/negative results would typically be established by:

Quantitative laboratory assays: Using a highly accurate reference method to measure hCG levels.
Clinical assessment: In some cases, confirming pregnancy status through other clinical means (though less common for in vitro diagnostic ground truth).

For the consumer studies, the "ground truth" for the interpretation ability would be derived from comparison to the device's actual performance (i.e., whether the consumer's interpretation matched the correct result as determined by the laboratory).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test sets. For IVD devices like pregnancy tests, adjudication among human readers or experts is less common for establishing the analytical ground truth (presence or absence of hCG) as the results are typically objectively measured by quantitative methods. However, for the consumer interpretation studies, it's possible internal protocols were used to resolve discrepancies if consumers disagreed on the interpretation of a test result, but this is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes laboratory studies comparing the new device to a predicate device, and consumer studies to assess user interpretation. These are not MRMC studies designed to assess the improvement of human readers with AI assistance, as this is a standalone diagnostic test, not an AI-assisted diagnostic tool.

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

Yes, a form of standalone performance was assessed. The "Brand Name 1-Step Pregnancy Test" is an in vitro diagnostic device, not an algorithm. Its "standalone" performance refers to its ability to detect hCG accurately on its own. The laboratory studies ("evaluation of the laboratory accuracy" and "evaluate and confirm the sensitivity") directly assess this standalone performance – how well the device itself, without human interpretation of ambiguous signals, determines the presence or absence of hCG. The consumer studies then assess the "human-in-the-loop" aspect: whether lay users can correctly interpret the device's output.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies (laboratory accuracy and sensitivity) would be based on quantitative biochemical assays for human chorionic gonadotropin (hCG) levels in urine samples. This would be the definitive measure of hCG concentration, allowing for the determination of true positive and true negative samples.

For the consumer interpretation studies, the ground truth for correct interpretation would be established by comparing the consumer's visual reading of the test lines against the known analytical result (positive or negative for hCG) of the sample used.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or artificial intelligence models. As the "Brand Name 1-Step Pregnancy Test" is an immunochromatographic device and not an AI algorithm, there is no training set in the conventional sense. The device's characteristics are inherent to its design and chemical reagents, not learned from data.

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

Since there is no training set for this type of device, this question is not applicable.

Summary

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510(k) SUMMARY II.

OCT 2 7 1997 Carter-Wallace Submitted By: Carter Products Division P.O. Box 1001, Half Acre Road Cranbury, New Jersey 08512-0181 (609) 655-6000 Contact Person: Theresa Sines September 4, 1997 Date Prepared: Brand Name* 1-Step Pregnancy Proprietary Name: *May be marketed under brand names yet to be determined, including ANSWER®, ANSWER QUICK & SIMPLE®, FIRST RESPONSE®, or others. At-Home Pregnancy Test Common Name: Human chorionic gonadotropin (hCG) test system Classification Name: Predicate Device: First Response® 1-Step Pregnancy Test

Description of the Device: The Brand Name 1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.

The Brand Name 1-Step Pregnancy test is substantially equivalent to the First Response® 1-Step Pregnancy Test distributed by Carter Products.

Intended Use of the Device: The Brand Name 1-Step Pregnancy Test is a simple-to-use at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of pregnancy.

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510(k) SUMMARY (cont'd) II.

Technological Characteristics: The Brand Name 1-Step Pregnancy Test has the same technological characteristics as the predicate device. It differs from the predicate device by utilizing a plastic stick with an absorbent tip which protrudes from the end of the device and collects and delivers the urine to reagents on the chromatographic strip contained within the device. The First Response 1-Step Pregnancy Test utilizes a plastic stick which encloses the absorbent pad and exposes a urine collection area on the underside of the stick. Both test products detect hCG, the hormone produced during pregnancy, by utilizing a double antibody immunochromatographic assay. Both tests use a direct label to visualize the immunoreaction indicating the presence of hCG. Both tests use colloidal gold which upon agglutination produces a pink/purple color. Both tests also utilize a third complexing reaction (between biotin and streptavidin) to produce an easy-to-read test result. These technological characteristics raise no new issues regarding safety or effectiveness.

The performance studies conducted included the evaluation of the laboratory accuracy of the Brand Name 1-Step Pregnancy Test and the ability of lay consumers to perform the test and interpret the result. Two laboratory studies were conducted to determine the performance of the Brand Name 1-Step Pregnancy Test in comparison to the predicate device, First Response® 1-Step Pregnancy Test. A third laboratory study was performed to evaluate and confirm the sensitivity of the Brand Name 1-Step Pregnancy Test. In three separate studies, the ability of consumers to perform and interpret the Brand Name 1-Step Pregnancy Test using both the midstream and dip methods was evaluated.

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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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 7 1997

Stephen C. Kolakowsky · Director, Requlatory Affairs Carter-Wallace, Inc. Half Acre Road P.O. Box 1001 Cranbury, New Jersey 08512-0181

K973352 Re : Brand Name 1-Step Pregnancy Test Requlatory Class: II Product Code: LCX Dated: September 4, 1997 Received: September 5, 1997

Dear Mr. Kolakowsky:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT VI.

510(k) Number (if known):

Brand Name 1-Step Pregnancy Test Device Name:

The Brand Name 1-Step Pregnancy Test is an at-home Indications For Use: pregnancy test marketed over-the-counter (OTC) to lay consumers. The Brand Name 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as the first day of the missed menses.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division:
Division:
510(k) Number: K973352

Over-The-Counter Use √

Prescription Use_ (Per 21 CFR 801.109)

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.