Cleared Traditional

K820728 - QUANTIMUNE ESTRIOL RIA

K820728 is the FDA 510(k) clearance for QUANTIMUNE ESTRIOL RIA by Bio-Rad. It is a Class 1 Chemistry device (product code CGI) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820728 · Bio-Rad · Chemistry device
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Apr 1982
Decision
20d
Days
Class 1
Risk

K820728 is an FDA 510(k) clearance for the QUANTIMUNE ESTRIOL 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 April 6, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1265 - 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 Bio-Rad devices

Submission Details

510(k) Number K820728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1982
Decision Date April 06, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 25
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K820728.
MICROMEDIC ESTRIOL RIA KIT
K822578 · Micromedic Systems · Oct 1982
DSL 1400
K822314 · Diagnostic Systems Laboratories, Inc. · Sep 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678 · Micromedic Systems · Jun 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · Diagnostic Products Corp. · Jan 1982
QUANTIMUNE ESTRIOL RIA
K811709 · Bio-Rad · Jul 1981
NATAL-TEC ESTRIOL
K811371 · Armkel, LLC · May 1981