TBD AT-HOME PREGNANCY TEST

K961712 · Armkel, LLC · LCX · May 31, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961712
• Device Name: TBD AT-HOME PREGNANCY TEST
• Applicant: Armkel, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The TBD 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 early pregnancy.

Device Story

At-home, OTC diagnostic test for early pregnancy detection. Input: urine sample collected via absorbent plastic stick. Principle: immunochemical chromatographic-chromogenic method; urine moves chromatographically along reagent strip; hCG detection triggers agglutination of colloidal gold particles. Output: visual result in window; two pink lines indicate hCG presence (pregnant); one pink line indicates absence (not-pregnant). Used by lay consumers in home setting. Results provide early pregnancy confirmation to assist in clinical decision-making.

Clinical Evidence

Bench testing included three laboratory studies: two comparing accuracy against the predicate device and one confirming sensitivity. Two separate consumer studies evaluated the ability of lay users to perform the test and interpret results.

Technological Characteristics

In vitro diagnostic device; immunochemical chromatographic-chromogenic assay. Materials: plastic housing, absorbent material, chromatographic strip with colloidal gold reagents. Principle: colloidal gold agglutination for visual colorimetric detection (pink).

Indications for Use

Indicated for lay consumers for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the early diagnosis of pregnancy.

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

• CLEARBLUE EASY™ One-Step Pregnancy Test

Submission Summary (Full Text)

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TBD Pregnancy Test 510(k)
May 1, 1996
Page 14

MAY 31 1996

510(k) SUMMARY

K961712

Submitted By: Carter-Wallace
Carter Products Division
P.O. Box 1001, Half Acre Road
Cranbury, New Jersey 08512-0181
[phone]

Contact Person: Maureen Garner

Date Prepared: May 1, 1996

Name of Device: At-home Pregnancy Test

Classification Name: Human chorionic gonadotropin (HCG) test system

Predicate Device: CLEARBLUE EASY™ One-Step Pregnancy Test

Description of the Device: The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographic-chromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent material that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by dipping the device into a container of urine for 20 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 in the urine sample (pregnant) is indicated by the appearance of two pink lines in the result window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.

The TBD Pregnancy Test is substantially equivalent to CLEARBLUE™ Easy One-Step Pregnancy Test manufactured by Whitehall Laboratories, Inc.

Intended Use of the Device: The TBD 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 early pregnancy.

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TBD Pregnancy Test 510(k)
May 1, 1996 Page 15

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

Technological Characteristics: The TBD Pregnancy Test has similar technological characteristics as the predicate device although it differs from the predicate device in the type of direct label used to visualize the immunoreaction that indicates the presence of hCG. The TBD test uses colloidal gold which upon agglutination optically produces a pink color. The CLEARBLUE Easy™ device uses blue latex beads which upon agglutination produces a blue color. This difference has no technological significance other than to yield a pink-to-purple result line in the subject device and to yield a blue result line in the predicate device. The TBD test also differs in that it utilizes a third complexing reaction to enhance and produce the easy-to-read test result. These minor technological differences raise no new issues regarding safety or effectiveness.

The performance studies conducted included the evaluation of the laboratory accuracy of the TBD 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 TBD test in comparison to the predicate device, CLEARBLUE Easy™ test. A third laboratory study was performed to evaluate and confirm the sensitivity of the TBD test. In two separate studies, the ability of consumers to perform and interpret the TBD Pregnancy Test was evaluated.