Cleared Traditional

K943580 - AUTOSTAT II ANTI-TPO

K943580 is the FDA 510(k) clearance for AUTOSTAT II ANTI-TPO by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code JNL) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

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
Combination Product No
PCCP Authorized No
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 11
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K943580.
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · Hycor Biomedical, Inc. · Nov 1996
AURAFLEX TG-AB AND TPO-AB
K951320 · Organon Teknika Corp. · Aug 1995
AURAFLEX TPO-AB
K952607 · Organon Teknika Corp. · Aug 1995
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · Cogent Diagnotics , Ltd. · Sep 1992
SYNELISA TPO ANTIBODIES
K921787 · Elias U.S.A., Inc. · Jul 1992