Cleared Traditional

ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K902556) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 51
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