Cleared Traditional

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (K991890) - FDA 510(k) Clearance

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

K991890 · Cogent Diagnotics , Ltd. · Immunology device
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Aug 1999
Decision
67d
Days
Class 2
Risk

K991890 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA. Classified as Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (product code MVJ), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on August 9, 1999 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 K991890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1999
Decision Date August 09, 1999
Days to Decision 67 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
37d faster than avg
Panel avg: 104d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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.