Cleared Traditional

K823313 - IN VITRO GAMMACOAT B-HCG RADIO. TEST

K823313 is the FDA 510(k) clearance for IN VITRO GAMMACOAT B-HCG RADIO. TEST by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K823313 · Clinical Assays, Inc. · Chemistry device
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Dec 1982
Decision
47d
Days
Class 2
Risk

K823313 is an FDA 510(k) clearance for the IN VITRO GAMMACOAT B-HCG RADIO. TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 47 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K823313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1982
Decision Date December 22, 1982
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
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 206
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K823313.
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138 · Hybritech, Inc. · Feb 1983
GENESIS B-HCG
K823753 · Armkel, LLC · Jan 1983
B-HCG
K822343 · Diagnostic Products Corp. · Sep 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · Hybritech, Inc. · Jul 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · Hoffmann-La Roche, Inc. · May 1982