Cleared Traditional

K972288 - FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

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

K972288 · Universal Reagents, Inc. · Hematology device
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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

FDA 510(k) Submission Details - K972288

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
Combination Product No
PCCP Authorized No
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.

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 156
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K972288.
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005 · Reaads Medical Products, Inc. · Aug 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482 · Reaads Medical Products, Inc. · Aug 1997
VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc. · Jul 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · The Binding Site, Ltd. · Apr 1997
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · Universal Reagents, Inc. · Dec 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · Universal Reagents, Inc. · Dec 1996