Cleared Traditional

K882002 - PREGNAGEN(TM)

K882002 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 119-day FDA review.

K882002 · Biogenex Laboratories · Chemistry device
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Sep 1988
Decision
119d
Days
Class 2
Risk

K882002 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 September 9, 1988 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biogenex Laboratories devices

Submission Details

510(k) Number K882002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date September 09, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
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 K882002.
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
QTEST(TM) PREGNANCY
K882086 · Quidel Corp. · Jul 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · Amersham Corp. · Jun 1988