Cleared Traditional

K821092 - GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

K821092 is the FDA 510(k) clearance for GAMMADAB[125]EGE RADIOIMMUNOASSAY IT by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K821092 · Clinical Assays, Inc. · Chemistry device
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Jun 1982
Decision
64d
Days
Class 2
Risk

K821092 is an FDA 510(k) clearance for the GAMMADAB[125]EGE RADIOIMMUNOASSAY IT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1982 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - 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 K821092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1982
Decision Date June 22, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 85
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K821092.
RAST ALLERCOAT ALLERGEN DISCS
K822613 · Kallestad Laboratories, Inc. · Oct 1982
VAST VENTREX RAST ALLERGEN DISCS
K822442 · Ventrex Laboratories, Inc. · Sep 1982
TOTAL IGE DISCS
K822206 · Kallestad Laboratories, Inc. · Aug 1982
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K820977 · Ventrex Laboratories, Inc. · Jun 1982
VENTRE/SPEC ALLERGEN CONTROL-INHALANT
K820978 · Ventrex Laboratories, Inc. · Jun 1982
VAST VENTREX PD IGE RIA TEST SET
K821615 · Ventrex Laboratories, Inc. · Jun 1982