Cleared Traditional

K871294 - ACU-PREG-AL SLIDE TEST

K871294 is an FDA 510(k) clearance for ACU-PREG-AL SLIDE TEST, manufactured by Papibris Scientific, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K871294 · Papibris Scientific, Inc. · Chemistry device
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May 1987
Decision
42d
Days
Class 2
Risk

K871294 is an FDA 510(k) clearance for the ACU-PREG-AL SLIDE TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Papibris Scientific, Inc. (Miami, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Papibris Scientific, Inc. devices

FDA 510(k) Submission Details - K871294

510(k) Number K871294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date May 12, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K871294.
HCG-NOSTICK
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K875262 · Texas Immunology, Inc. · Feb 1988
V-TREND BETA-HCG TEST
K874638 · Texas Immunology, Inc. · Jan 1988
PREGNASLIDE
K863198 · Armkel, LLC · Sep 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · Leeco Diagnostics, Inc. · Jul 1986
DELFIA (TM) HCG KIT
K862044 · Lkb Instruments, Inc. · Jul 1986