Cleared Traditional

K884880 - PREGNAGEN(TM)

K884880 is the FDA 510(k) clearance for PREGNAGEN(TM) by Biogenex Laboratories. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K884880 · Biogenex Laboratories · Chemistry device
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Jan 1989
Decision
53d
Days
Class 2
Risk

K884880 is an FDA 510(k) clearance for the PREGNAGEN(TM). Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biogenex Laboratories (San Ramon, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 53 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 Biogenex Laboratories devices

Submission Details

510(k) Number K884880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date January 13, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K884880.
ABBOTT TESTPACK PLUS HCG URINE
K894408 · Abbott Laboratories · Sep 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · Quidel Corp. · Apr 1989
VENTREX COATED TUBE HCG
K890549 · Ventrex Laboratories, Inc. · Mar 1989
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · Ciba Corning Diagnostics Corp. · Oct 1988
CLEARVIEW HCG
K883777 · Unipath , Ltd. · Oct 1988
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988