Cleared Traditional

K961929 - FACTOR DEFICIENT PLASMA

K961929 is the FDA 510(k) clearance for FACTOR DEFICIENT PLASMA by Universal Reagents, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K961929 · Universal Reagents, Inc. · Hematology device
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Oct 1996
Decision
146d
Days
Class 2
Risk

K961929 is an FDA 510(k) clearance for the FACTOR DEFICIENT PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Universal Reagents, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 146 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 Universal Reagents, Inc. devices

Submission Details

510(k) Number K961929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date October 10, 1996
Days to Decision 146 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
33d slower than avg
Panel avg: 113d · This submission: 146d
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 K961929.
HUMAN PROTEIN S RID TEST KIT
K951640 · The Binding Site, Ltd. · Apr 1997
PROC APC ASSAY, PROC CONTROL PLASMA
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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
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126 · Aalto Scientific, Ltd. · Feb 1996