Cleared Traditional

K802455 - ESTRIOL-SQUIBB RIA KIT

K802455 is the FDA 510(k) clearance for ESTRIOL-SQUIBB RIA KIT by E. R. Squibb & Sons, Inc.. It is a Class 1 Chemistry device (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.

View all E. R. Squibb & Sons, Inc. devices

Submission Details

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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 26
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K802455.
NATAL-TEC ESTRIOL
K811371 · Armkel, LLC · May 1981
AMERLEX ESTRIOL RIA KIT
K810667 · Amersham Corp. · Mar 1981
QUANTIMUNE E3 RIA
K802944 · Bio-Rad · Dec 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980
TOTAL ESTRIOL RIA KIT
K800036 · Amersham Corp. · Jan 1980
RIA, QUANTIMUNE E3
K781850 · Bio-Rad · Jan 1979