FIRST RESPONSE 1-STEP PREGNANCY

K992232 · Armkel, LLC · LCX · Dec 21, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992232
• Device Name: FIRST RESPONSE 1-STEP PREGNANCY
• Applicant: Armkel, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The First Response® 1-Step Pregnancy Test is a simple-touse 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. The directions for use for the First Response® 1-Step Pregnancy Test state that the test can be used as early as three days before the expected menses.

Device Story

At-home lateral flow immunochromatographic assay; detects hCG in urine. Device consists of plastic stick with absorbent tip; tip placed in urine stream or container for 5 seconds. Urine migrates along chromatographic strip; reconstitutes diffusible reagents. Employs double antibody assay; colloidal gold label for visualization; biotin-streptavidin complexing reaction. Results displayed in test window: two pink lines indicate hCG presence (pregnant); one pink line indicates absence (not pregnant). Used by lay consumers; provides rapid visual qualitative result to aid pregnancy diagnosis.

Clinical Evidence

Bench testing and consumer studies performed. Quantitative market research evaluated consumer ability to understand package inserts and perform the test. Laboratory studies confirmed clinical sensitivity for hCG detection in samples collected prior to missed menses. No specific sensitivity/specificity percentages or p-values provided in summary.

Technological Characteristics

Plastic stick with absorbent tip; chromatographic strip. Double antibody immunochromatographic assay. Colloidal gold label; biotin-streptavidin complexing. Visual qualitative readout. Non-electronic, manual test.

Indications for Use

Indicated for lay consumers for at-home detection of hCG in urine as an aid in early pregnancy diagnosis. Can be used anytime of day, as early as three days before expected period.

Regulatory Classification

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. 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.

Predicate Devices

• First Response® 1-Step Pregnancy Test

Submission Summary (Full Text)

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July 1, 1999 Page 2

# DEC 2 1 1999

K992232

#### 510(k) SUMMARY II.

| Submitted By: | Carter-Wallace<br>Carter Products Division<br>P.O. Box 1001, Half Acre Road<br>Cranbury, New Jersey 08512-0181<br>[phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen Garner |
| Date Prepared: | July 1, 1999 |
| Proprietary Name: | First Response® 1-Step Pregnancy |
| Common Name: | At-Home Pregnancy Test |
| Classification Name: | Human chorionic gonadotropin (hCG) test system |
| Predicate Device: | First Response® 1-Step Pregnancy Test |

Description of the Device: The First Response®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.

Intended Use of the Device: The First Response® 1-Step Pregnancy Test is a simple-touse 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. The directions for use for the First Response® 1-Step Pregnancy Test state that the test can be used as early as three days before the expected menses.

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

Technological Characteristics: The First Response® 1-Step Pregnancy Test utilizes 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 test product detects hCG, the hormone produced during pregnancy, by utilizing a double antibody immunochromatographic assay and uses a direct label to visualize the immunoreaction indicating the presence of hCG. The test uses colloidal gold, which upon agglutination produces a pink/purple color and also utilizes a third complexing reaction (between biotin and streptavidin) to produce an easy-to-read test result.

The performance studies conducted included the evaluation of consumer accuracy in reading low levels of hCG using the First Response® 1-Step Pregnancy Test and the ability of lay consumers to perform the test and interpret the result. A quantitative market research study was performed to evaluate consumers' ability to understand the package insert, which indicates that the test can be used before the expected period. A laboratory study was performed to evaluate and confirm the clinical sensitivity of the First Response® 1-Step Pregnancy Test using samples collected prior to missed menses.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 1999

Ms. Maureen N. Garner Manager, Regulatory Affairs Carter-Wallace, Inc. Half Acre Road P.O. Box 1001 Cranbury, New Jersey 08512-0181

Re: K992232

Trade Name: First Response® 1-Step Pregnancy Test Regulatory Class: II Product Code: LCX Dated: October 4, 1999 Received: October 5, 1999

Dear Ms. Garner:

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 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). 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 Regulations, Title 21, Parts 800 to 895. A 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 regulations.

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Page 2

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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.

5992232 510(k) Number:

First Response® 1-Step Pregnancy Test Device Name:

The First Response® 1-Step Pregnancy Test is an at-home Indications For Use: pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® I-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as three days before the expected period.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Veronica Meluer for Jla Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K992332/A4 |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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