Cleared Traditional

K831155 - B-CLONE HCG ASSAY

K831155 is the FDA 510(k) clearance for B-CLONE HCG ASSAY by Monoclonal Antibodies, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K831155 · Monoclonal Antibodies, Inc. · Chemistry device
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Jun 1983
Decision
55d
Days
Class 2
Risk

K831155 is an FDA 510(k) clearance for the B-CLONE HCG ASSAY. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Monoclonal Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 55 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 Monoclonal Antibodies, Inc. devices

Submission Details

510(k) Number K831155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date June 02, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K831155.
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BETA FFIRM TEST
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ACCURATE BETA
K812967 · Organon, Inc. · Nov 1981
ANSWER (R)
K812924 · Armkel, LLC · Nov 1981