Cleared Traditional

K972288 - FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

K972288 is the FDA 510(k) clearance for FACTOR DEFICIENT PLASMAS - FACTOR IX (9) by Universal Reagents, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K972288 · Universal Reagents, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
25d
Days
Class 2
Risk

K972288 is an FDA 510(k) clearance for the FACTOR DEFICIENT PLASMAS - FACTOR IX (9). 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 July 14, 1997 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Universal Reagents, Inc. devices

Submission Details

510(k) Number K972288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date July 14, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
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 K972288.
COAMATIC FACTOR VIII
K981038 · Instrumentation Laboratory CO · Apr 1998
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
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · Behring Diagnostics, Inc. · Dec 1996
CHROMOLIZE PAI-1 KIT
K963106 · Medical Diagnostic Technologies, Inc. · Nov 1996