Cleared Traditional

K962875 - ACTIVE ULTRASENSITIVE UNCONJUGATED ESTR...

K962875 is the FDA 510(k) clearance for ACTIVE ULTRASENSITIVE UNCONJUGATED ESTR... by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CGI) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K962875 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Aug 1996
Decision
30d
Days
Class 1
Risk

K962875 is an FDA 510(k) clearance for the ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA. 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 August 23, 1996 after a review of 30 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K962875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1996
Decision Date August 23, 1996
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 25
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K962875.
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