Cleared Traditional

K781546 - DIRECT ESTRIOL RIA KIT

K781546 is an FDA 510(k) clearance for DIRECT ESTRIOL RIA KIT, manufactured by Immunalysis Corporation. The device is a Class 1 Chemistry device with product code CGI cleared through the Traditional 510(k) pathway after a 82-day FDA review.

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

FDA 510(k) Submission Details - K781546

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 31
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K781546.
TOTAL ESTRIOL RIA KIT
K800036 · Amersham Corp. · Jan 1980
RIA KIT, GAMMADAB ESTRIOL
K781938 · Clinical Assays, Inc. · Jan 1979
RIA, QUANTIMUNE E3
K781850 · Bio-Rad · Jan 1979
HUMAN FOLLICLE STIMULATING HORMONE
K780016 · Pcl-Ria, Inc. · Feb 1978
RIANEN ESTRIOL RIA KIT
K772323 · New England Nuclear · Jan 1978
UNCONJUGATED ESTRIOL RIA KIT
K772215 · Amersham Corp. · Dec 1977