Cleared Traditional

K891337 - THROMBOSCREEN APTT REAGENT

K891337 is an FDA 510(k) clearance for THROMBOSCREEN APTT REAGENT, manufactured by Pacific Hemostasis. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K891337 · Pacific Hemostasis · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
42d
Days
Class 2
Risk

K891337 is an FDA 510(k) clearance for the THROMBOSCREEN APTT REAGENT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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.

FDA 510(k) Submission Details - K891337

510(k) Number K891337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date April 21, 1989
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 51
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K891337.
APTT BY HEMOCHRON(R)
K892209 · Intensive Technology, Inc. · Jun 1989
COAG-1 APTT TEST CARD
K891015 · Cardiovascular Diagnostic Services · May 1989
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
K890859 · Elite Diagnostic , Ltd. · Apr 1989
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K890619 · Elite Diagnostic , Ltd. · Mar 1989
BIOTRACK APTT REAGENT CARTRIDGE
K890052 · Biotrack, Inc. · Feb 1989
APTT REAGENT
K884856 · Precision Biologicals, Inc. · Jan 1989
K891337 · THROMBOSCREEN APTT REAGENT
Download PDF Pacific Hemostasis