Cleared Traditional

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (K991942) - FDA 510(k) Clearance

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

K991942 · Cogent Diagnotics , Ltd. · Immunology device
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Aug 1999
Decision
76d
Days
Class 2
Risk

K991942 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA. Classified as Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (product code MLE), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on August 24, 1999 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5110 - 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 K991942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date August 24, 1999
Days to Decision 76 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
28d faster than avg
Panel avg: 104d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5110
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.