Cleared Traditional

K902556 - ACS ACTIVATED PARTIAL THROMBOPLASTIN TI...

K902556 is the FDA 510(k) clearance for ACS ACTIVATED PARTIAL THROMBOPLASTIN TI... by Analytical Control Systems, Inc.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K902556 · Analytical Control Systems, Inc. · Hematology device
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Aug 1990
Decision
59d
Days
Class 2
Risk

K902556 is an FDA 510(k) clearance for the ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on August 6, 1990 after a review of 59 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K902556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date August 06, 1990
Days to Decision 59 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
54d faster than avg
Panel avg: 113d · This submission: 59d
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 K902556.
HEMOCHRON ONESTEP APTT TEST
K915344 · International Technidyne Corp. · Feb 1992
HEMOCHRON(R) APTT, MODIFICATION
K911994 · International Technidyne Corp. · Jul 1991
APTT REAGENT
K904341 · Sigma Chemical Co. · Nov 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049 · Medical Diagnostic Technologies, Inc. · Jan 1990
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545 · Sigma Chemical Co. · Dec 1989
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255 · Medical Diagnostic Technologies, Inc. · Oct 1989