Cleared Traditional

K882325 - UNIFAST ACTIVATED PARTIAL THROMBOPLASTI...

K882325 is the FDA 510(k) clearance for UNIFAST ACTIVATED PARTIAL THROMBOPLASTI... by Sclavo, Inc.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K882325 · Sclavo, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
80d
Days
Class 2
Risk

K882325 is an FDA 510(k) clearance for the UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on August 25, 1988 after a review of 80 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.

View all Sclavo, Inc. devices

Submission Details

510(k) Number K882325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date August 25, 1988
Days to Decision 80 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
33d faster than avg
Panel avg: 113d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K882325.
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255 · Medical Diagnostic Technologies, Inc. · Oct 1989
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
K884702 · Em Diagnostic Systems, Inc. · Jan 1989
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · King Diagnostics, Inc. · Dec 1988
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1982
HEPARIN CONTROL PLASMA
K760918 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1977
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1976