Cleared Traditional

K952283 - AMERLITE HCG-60 ASSAY

K952283 is the FDA 510(k) clearance for AMERLITE HCG-60 ASSAY by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K952283 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Jul 1995
Decision
62d
Days
Class 2
Risk

K952283 is an FDA 510(k) clearance for the AMERLITE HCG-60 ASSAY. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 62 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 Johnson & Johnson Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K952283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date July 17, 1995
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, 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 - DHA System, Test, Human Chorionic Gonadotropin

All 44
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K952283.
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ELECSYS HCG ASSAY
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K950307 · Princeton BioMeditech Corp. · Mar 1995
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