Cleared Traditional

K963106 - CHROMOLIZE PAI-1 KIT

K963106 is an FDA 510(k) clearance for CHROMOLIZE PAI-1 KIT, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K963106 · Medical Diagnostic Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
98d
Days
Class 2
Risk

K963106 is an FDA 510(k) clearance for the CHROMOLIZE PAI-1 KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on November 18, 1996 after a review of 98 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K963106

510(k) Number K963106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date November 18, 1996
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K963106.
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · Universal Reagents, Inc. · Dec 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · Universal Reagents, Inc. · Dec 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · Behring Diagnostics, Inc. · Dec 1996
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825 · Shield Diagnostics, Ltd. · Nov 1996
FACTOR DEFICIENT PLASMA
K961929 · Universal Reagents, Inc. · Oct 1996
CHROMOLIZE TPA ASSAY KIT
K962489 · Medical Diagnostic Technologies, Inc. · Jul 1996