Cleared Traditional

K962968 - PROC APC ASSAY

K962968 is the FDA 510(k) clearance for PROC APC ASSAY by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K962968 · Behring Diagnostics, Inc. · Hematology device
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Dec 1996
Decision
136d
Days
Class 2
Risk

K962968 is an FDA 510(k) clearance for the PROC APC ASSAY, PROC CONTROL PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 136 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K962968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date December 13, 1996
Days to Decision 136 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 113d · This submission: 136d
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 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K962968.
ASSERACHROM TPA TEST KIT
K971519 · American Bioproducts Co. · Aug 1997
VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc. · Jul 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · The Binding Site, Ltd. · Apr 1997
CHROMOLIZE PAI-1 KIT
K963106 · Medical Diagnostic Technologies, Inc. · Nov 1996
CHROMOLIZE TPA ASSAY KIT
K962489 · Medical Diagnostic Technologies, Inc. · Jul 1996
TINTELIZE PAI-1 KIT
K960438 · Medical Diagnostic Technologies, Inc. · Jun 1996