Cleared Traditional

K993553 - GTI-FVIII INHIBITOR ASSAY

K993553 is the FDA 510(k) clearance for GTI-FVIII INHIBITOR ASSAY by Genetic Testing Institute. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K993553 · Genetic Testing Institute · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
104d
Days
Class 2
Risk

K993553 is an FDA 510(k) clearance for the GTI-FVIII INHIBITOR ASSAY. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Genetic Testing Institute (Brookfield, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genetic Testing Institute devices

Submission Details

510(k) Number K993553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1999
Decision Date February 01, 2000
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 113d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K993553.
COALIZA PROTEIN S-FREE
K002467 · Instrumentation Laboratory CO · Oct 2000
PROTEIN C REAGENT
K002541 · Dade Behring, Inc. · Sep 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · Dade Behring, Inc. · Apr 2000
IL TEST VON WILLEBRAND FACTOR
K992704 · Instrumentation Laboratory CO · Nov 1999
COAMATIC PLASMIN INHIBITOR
K981817 · Instrumentation Laboratory CO · Sep 1998
IL TEST PLASMIN INHIBITOR
K981696 · Instrumentation Laboratory CO · Aug 1998