Cleared Traditional

RSL'S ASSAY PROCEDURE QUANTITATION (K791728) - FDA 510(k) Clearance

Class I Chemistry device.

K791728 · Radioassay Systems Laboratories, Inc. · Chemistry device
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Sep 1979
Decision
28d
Days
Class 1
Risk

K791728 is an FDA 510(k) clearance for the RSL'S ASSAY PROCEDURE QUANTITATION. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 28 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 Radioassay Systems Laboratories, Inc. devices

Submission Details

510(k) Number K791728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1979
Decision Date September 27, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 11
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K791728.
QUANTIMUNE ESTRIOL RIA
K811709 · Bio-Rad · Jul 1981
QUANTIMUNE E3 RIA
K802944 · Bio-Rad · Dec 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980
RIA, QUANTIMUNE E3
K781850 · Bio-Rad · Jan 1979
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977