Cleared Traditional

K955356 - ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL

K955356 is an FDA 510(k) clearance for ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CGI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K955356 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
176d
Days
Class 1
Risk

K955356 is an FDA 510(k) clearance for the ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 176 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K955356

510(k) Number K955356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date May 15, 1996
Days to Decision 176 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
88d slower than avg
Panel avg: 88d · This submission: 176d
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 K955356.
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K974721 · Bayer Corp. · Mar 1998
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875 · Diagnostic Systems Laboratories, Inc. · Aug 1996
COAT-A-COUNT FREE ESTRIOL
K932989 · Diagnostic Products Corp. · Dec 1994
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490 · Wallac OY · Dec 1994
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576 · Eastman Kodak Company · Mar 1992
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · Immunotech Corp. · Aug 1990