Cleared Traditional

K943625 - AUTOSTAT II ANTI-THYROGLOBULIN

K943625 is the FDA 510(k) clearance for AUTOSTAT II ANTI-THYROGLOBULIN by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code DDC) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K943625 · Cogent Diagnotics , Ltd. · Immunology device
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Dec 1994
Decision
149d
Days
Class 2
Risk

K943625 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-THYROGLOBULIN. Classified as Thyroglobulin, Antigen, Antiserum, Control (product code DDC), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on December 22, 1994 after a review of 149 days - within the typical 510(k) review window.

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 K943625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date December 22, 1994
Days to Decision 149 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
45d slower than avg
Panel avg: 104d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDC Thyroglobulin, Antigen, Antiserum, Control
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 - DDC Thyroglobulin, Antigen, Antiserum, Control

Devices cleared under the same product code (DDC) and FDA review panel - the closest regulatory comparables to K943625.
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