BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES

K962183 · Armkel, LLC · LCX · Jul 10, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962183
• Device Name: BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
• Applicant: Armkel, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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 early pregnancy.

Device Story

In vitro diagnostic device; immunochemical chromatographic-chromogenic method. Input: urine sample collected via absorbent pad (stream or dip for 5 seconds). Operation: urine moves chromatographically along reagent strip; reconstitutes diffusible reagents; delivers to capture zones. Output: visual result in test window (two pink lines = pregnant; one pink line = not-pregnant). Used at-home by lay consumers. Result provides early pregnancy detection aid.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic stick housing absorbent pad and chromatographic reagent strip. Immunochemical detection principle. Standalone, non-electronic, disposable device.

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

• One-Step CLEARBLUE Easy™ Pregnancy Test

Submission Summary (Full Text)

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Brand Name 1-Step Pregnancy Test
510(k) Notification
June 5, 1996
Page 13

# 510(k) SUMMARY

K962183

JUL 10 1996

## 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:
June 5, 1996

## Name of Device:
Brand Name 1-Step Pregnancy Test

## Classification Name:
Human chorionic gonadotropin (hCG) test system

## Predicate Device:
One-Step CLEARBLUE Easy™ 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 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 pad that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent pad of the device in the urine stream for 5 seconds or by dipping the device 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 in the urine sample (pregnant) 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 One Step CLEARBLUE™ Easy Pregnancy test distributed by Whitehall Laboratories, Inc.

## 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 early pregnancy.