Cleared Traditional

AUTOSTAT II ANTI-TPO (K943580) - FDA 510(k) Clearance

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

K943580 · Cogent Diagnotics , Ltd. · Immunology device
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Apr 1995
Decision
269d
Days
Class 2
Risk

K943580 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-TPO. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on April 17, 1995 after a review of 269 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 K943580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date April 17, 1995
Days to Decision 269 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
165d slower than avg
Panel avg: 104d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JNL Immunochemical, Thyroglobulin Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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.

Regulatory Peers - JNL Immunochemical, Thyroglobulin Autoantibody

All 21
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K943580.
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · Siemens Healthcare Diagnostics, Inc. · Dec 2025
Access Thyroglobulin Antibody II
K240996 · Beckman Coulter, Inc. · Jul 2024
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006