Cleared Traditional

DIRECT ESTRIOL RIA KIT (K781546) - FDA 510(k) Clearance

Class I Chemistry device.

K781546 · Immunalysis Corporation · Chemistry device
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Dec 1978
Decision
82d
Days
Class 1
Risk

K781546 is an FDA 510(k) clearance for the DIRECT ESTRIOL RIA KIT. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 82 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 Immunalysis Corporation devices

Submission Details

510(k) Number K781546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1978
Decision Date December 04, 1978
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K781546.
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