Cleared Traditional

K920576 - AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL

K920576 is an FDA 510(k) clearance for AMERLEX-M HIGH SENSITIVITY UNCONJUGATED..., manufactured by Eastman Kodak Company. The device is a Class 1 Chemistry device with product code CGI cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K920576 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
42d
Days
Class 1
Risk

K920576 is an FDA 510(k) clearance for the AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 42 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K920576

510(k) Number K920576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date March 23, 1992
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K920576.
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356 · Diagnostic Systems Laboratories, Inc. · May 1996
COAT-A-COUNT FREE ESTRIOL
K932989 · Diagnostic Products Corp. · Dec 1994
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490 · Wallac OY · Dec 1994
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · Immunotech Corp. · Aug 1990
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · Sclavo, Inc. · Apr 1986
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985