Cleared Traditional

K960438 - TINTELIZE PAI-1 KIT

K960438 is an FDA 510(k) clearance for TINTELIZE 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 126-day FDA review.

K960438 · Medical Diagnostic Technologies, Inc. · Hematology device
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Jun 1996
Decision
126d
Days
Class 2
Risk

K960438 is an FDA 510(k) clearance for the TINTELIZE 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 June 5, 1996 after a review of 126 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 - K960438

510(k) Number K960438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1996
Decision Date June 05, 1996
Days to Decision 126 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
13d slower than avg
Panel avg: 113d · This submission: 126d
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 K960438.
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825 · Shield Diagnostics, Ltd. · Nov 1996
FACTOR DEFICIENT PLASMA
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CHROMOLIZE TPA ASSAY KIT
K962489 · Medical Diagnostic Technologies, Inc. · Jul 1996
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126 · Aalto Scientific, Ltd. · Feb 1996
BIOCLOT PROTEIN S
K955738 · Medical Diagnostic Technologies, Inc. · Feb 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · Helena Laboratories · Feb 1996