Cleared Traditional

K821611 - GAMMADAB [125] FSH RADIOIMMUNAY KIT

K821611 is the FDA 510(k) clearance for GAMMADAB [125] FSH RADIOIMMUNAY KIT by Clinical Assays, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821611 · Clinical Assays, Inc. · Chemistry device
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Jun 1982
Decision
22d
Days
Class 1
Risk

K821611 is an FDA 510(k) clearance for the GAMMADAB [125] FSH RADIOIMMUNAY KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 K821611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date June 24, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 54
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K821611.
FSH RIA
K833852 · Syncor Intl. Corp. · Jan 1984
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · Bio-Rad · Jul 1983
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · Corning Medical & Scientific · Aug 1982
AMERLEX ESH KIT
K820754 · Amersham Corp. · Apr 1982
FOLLICLE STIMULATING HORMONE KIT
K820358 · Pcl-Ria, Inc. · Mar 1982
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · Immunalysis Corporation · Jul 1981