Cleared Traditional

QUANTIMUNE E3 RIA (K802944) - FDA 510(k) Clearance

Class I Toxicology device.

K802944 · Bio-Rad · Toxicology device
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Dec 1980
Decision
33d
Days
Class 1
Risk

K802944 is an FDA 510(k) clearance for the QUANTIMUNE E3 RIA. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1265 - the FDA toxicology device 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.

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Submission Details

510(k) Number K802944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date December 22, 1980
Days to Decision 33 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 87d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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 - CGI Radioimmunoassay, Estriol

All 41
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K802944.
COAT-A-COUNT FREE ESTRIOL
K932989 · Diagnostic Products Corp. · Dec 1994
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576 · Eastman Kodak Company · Mar 1992
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985
FREE & TOTAL ESTRIOL KIT
K823202 · Diagnostic Products Corp. · Dec 1982
QUANTIMUNE ESTRIOL RIA
K820728 · Bio-Rad · Apr 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · Diagnostic Products Corp. · Jan 1982