Cleared Traditional

K802455 - ESTRIOL-SQUIBB RIA KIT

K802455 is an FDA 510(k) clearance for ESTRIOL-SQUIBB RIA KIT, manufactured by E. R. Squibb & Sons, Inc.. The device is a Class 1 Chemistry device with product code CGI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K802455 · E. R. Squibb & Sons, Inc. · Chemistry device
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Oct 1980
Decision
23d
Days
Class 1
Risk

K802455 is an FDA 510(k) clearance for the ESTRIOL-SQUIBB RIA KIT. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 23 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.

FDA 510(k) Submission Details - K802455

510(k) Number K802455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date October 31, 1980
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

CGI Device Classification - Class 1, General Controls

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 K802455.
AMERLEX ESTRIOL RIA KIT
K810667 · Amersham Corp. · Mar 1981
IMMUNOREACTIVE ESTRIOL RIA KIT
K802754 · Microanalytic Research, Inc. · Jan 1981
QUANTIMUNE E3 RIA
K802944 · Bio-Rad · Dec 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
K801424 · Squibb & Sons, Inc. · Jul 1980
TOTAL ESTRIOL RIA KIT
K800036 · Amersham Corp. · Jan 1980
K802455 · ESTRIOL-SQUIBB RIA KIT
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