Cleared Traditional

AUTOSTATTMII ANTI-DSDNA (K952567) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952567 · Cogent Diagnotics , Ltd. · Immunology device
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Mar 1997
Decision
638d
Days
Class 2
Risk

K952567 is an FDA 510(k) clearance for the AUTOSTATTMII ANTI-DSDNA. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on March 4, 1997 after a review of 638 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K952567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date March 04, 1997
Days to Decision 638 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
534d slower than avg
Panel avg: 104d · This submission: 638d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.