Cleared Traditional

K970593 - UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA

K970593 is an FDA 510(k) clearance for UNIVERSAL REAGENT FACTOR VIII DEFICIENT..., manufactured by Universal Reagents, Inc.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K970593 · Universal Reagents, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
66d
Days
Class 2
Risk

K970593 is an FDA 510(k) clearance for the UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Universal Reagents, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 25, 1997 after a review of 66 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 - K970593

510(k) Number K970593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date April 25, 1997
Days to Decision 66 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
47d faster than avg
Panel avg: 113d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJT Device Classification - Class 2, Special Controls

Product Code GJT Plasma, Coagulation Factor Deficient
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 - GJT Plasma, Coagulation Factor Deficient

All 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K970593.
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · Precision Biologicals, Inc. · Jul 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · Precision Biologicals, Inc. · Jul 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · Universal Reagents, Inc. · Jul 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607 · Universal Reagents, Inc. · Apr 1997
STA - LIATEST VWF TEST KIT
K962675 · American Bioproducts Co. · Oct 1996
STA-VWF CALIBRATOR KIT
K962671 · American Bioproducts Co. · Sep 1996