Cleared Traditional

K925784 - AUTOSTAT ANTITHYROGLOBIN

K925784 is the FDA 510(k) clearance for AUTOSTAT ANTITHYROGLOBIN by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K925784 · Cogent Diagnotics , Ltd. · Immunology device
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Jan 1993
Decision
79d
Days
Class 2
Risk

K925784 is an FDA 510(k) clearance for the AUTOSTAT ANTITHYROGLOBIN. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Dunblane, Fk15 9ep, GB). The FDA issued a Cleared decision on January 21, 1993 after a review of 79 days - a notably fast clearance 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: 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 Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K925784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date January 21, 1993
Days to Decision 79 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
25d faster than avg
Panel avg: 104d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZO System, Test, Thyroid 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 - JZO System, Test, Thyroid Autoantibody

All 44
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K925784.
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · Immco Diagnostics, Inc. · Jun 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · Immco Diagnostics, Inc. · Jun 1996
QUANTA LITE(TM) THYROID M ELISA
K930485 · Inova Diagnostics, Inc. · Mar 1993
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K925785 · Cogent Diagnotics , Ltd. · Jan 1993
ELIAS TGAB
K925922 · Elias U.S.A., Inc. · Jan 1993
ELIAS TMAB
K925923 · Elias U.S.A., Inc. · Jan 1993