← Product Code [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX) · K953606

# BEST PREGNANCY TEST (K953606)

_Ameritek, Inc. · LCX · Mar 22, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K953606

## Device Facts

- **Applicant:** Ameritek, Inc.
- **Product Code:** [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX.md)
- **Decision Date:** Mar 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

Home pregnancy test kits can now be purchased from most drug stores without a prescription. There are approximately more than 10 various kinds of one step home pregnancy test kits available. These tests are virtually the same as the urine pregnancy tests performed in most doctoral office and clinics. The home pregnancy tests are convenient, private, and, if performed properly, can be quite accurate.

## Device Story

One step midstream pregnancy test kit; detects HCG hormone in urine via immunological reaction; utilizes affinity purified goat anti-mouse IgG, polyclonal anti-HCG, and monoclonal anti-HCG antibodies; intended for home use by women; provides qualitative pregnancy status; results facilitate early pregnancy identification.

## Clinical Evidence

Bench testing only. Laboratory testing demonstrated 100% accuracy in detecting pregnancy. Cross-reactivity testing showed negative results for LH levels < 200 mIU/ml. Performance compared to predicate device.

## Technological Characteristics

Immunochromatographic assay; utilizes affinity purified goat anti-mouse IgG, polyclonal anti-HCG, and monoclonal anti-HCG antibodies; midstream test format; qualitative detection of HCG in urine.

## Regulatory 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

- Be sure one step midstream pregnancy test kits

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

K953606

# Summary

Home pregnancy test kits can now be purchased from most drug stores without a prescription. There are approximately more than 10 various kinds of one step home pregnancy test kits available. These tests are virtually the same as the urine pregnancy tests performed in most doctoral office and clinics. The home pregnancy tests are convenient, private, and, if performed properly, can be quite accurate.

During pregnancy a fertilized egg implanted in the uterus wall, A hormone, called human chorionic gonadotropin (HCG) is then produced by the developing placenta and excreted in the urine. The amount of HCG excreted in the urine rises rapidly during the first weeks of pregnancy. Home pregnancy tests are designed to detect this pregnancy hormone in woman urine.

**One step Best midstream pregnancy test kids** detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG.

The test kit accuracy for pregnant women are 100% in laboratory test. The cross reactivity with LH is negative when LH level is less than 200 mIU/ml.

The data of our test kits compared with "Be sure" one step midstream pregnancy test kits, which were approved by FDA, indicates that the performance of both kits are very similar. Substantial equivalence should be determined.

9

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K953606](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K953606)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com