Cleared Traditional

AUTOSTAT ANTI-DSDNA (K925783) - FDA 510(k) Clearance

Class I Immunology device.

K925783 · Cogent Diagnotics , Ltd. · Immunology device
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Mar 1993
Decision
140d
Days
Class 1
Risk

K925783 is an FDA 510(k) clearance for the AUTOSTAT ANTI-DSDNA. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Cogent Diagnotics , Ltd. (Dunblane, Fk15 9ep, GB). The FDA issued a Cleared decision on March 22, 1993 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K925783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date March 22, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 104d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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