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Acu-Preg-Al Slide Test

by Papibris Scientific, Inc.

510(k) K871294

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871294 Date12 May 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JHJ
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Acu-Preg-Al Slide Test is an agglutination method device used for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It functions as a slide-based immunoassay to identify pregnancy by detecting hCG levels, a hormone produced during pregnancy.

This device is supplied as a single-use, non-sterile diagnostic test intended for use in clinical chemistry settings. It is classified as a Class II medical device under FDA regulation 862.1155 and was granted 510(k) clearance (K871294) in 1987. Storage and handling follow standard laboratory protocols for agglutination tests, with no specific MRI safety considerations.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Acu-Preg-Al Slide Test used for?

    The Acu-Preg-Al Slide Test is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples. It uses an agglutination method to identify pregnancy by detecting elevated hCG levels, a hormone produced during pregnancy. This test is specifically intended for use in clinical chemistry settings to confirm pregnancy status.

  • Is the Acu-Preg-Al Slide Test sterile?

    No, the Acu-Preg-Al Slide Test is supplied as a non-sterile diagnostic device. It is intended for single-use only, and standard laboratory protocols for handling non-sterile agglutination tests should be followed during storage and use.

  • How should the Acu-Preg-Al Slide Test be stored?

    The Acu-Preg-Al Slide Test should be stored according to standard laboratory protocols for agglutination tests. Since it is a single-use, non-sterile device, ensure it is kept in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for proper packaging and expiration dates.

  • Is this test reusable or intended for single-use?

    The Acu-Preg-Al Slide Test is explicitly designed for single-use only. After performing the test, the slide should be discarded to prevent cross-contamination and ensure accurate results. Reusing this device is not recommended and may compromise its performance.

  • What regulatory pathway does the Acu-Preg-Al Slide Test follow?

    The Acu-Preg-Al Slide Test is classified as a Class II medical device under FDA regulation 862.1155 and was granted 510(k) clearance (K871294) in 1987. It was reviewed by the FDA’s Clinical Chemistry (CH) Advisory Committee and is considered substantially equivalent to a predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness.