Cleared Traditional

K896545 - ACTIVATED PARTIAL THROMBOPLASTIN TIME (...

K896545 is the FDA 510(k) clearance for ACTIVATED PARTIAL THROMBOPLASTIN TIME (... by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K896545 · Sigma Chemical Co. · Hematology device
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Dec 1989
Decision
14d
Days
Class 2
Risk

K896545 is an FDA 510(k) clearance for the ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 14 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K896545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date December 01, 1989
Days to Decision 14 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
99d faster than avg
Panel avg: 113d · This submission: 14d
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 K896545.
APTT REAGENT
K904341 · Sigma Chemical Co. · Nov 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K902556 · Analytical Control Systems, Inc. · Aug 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049 · Medical Diagnostic Technologies, Inc. · Jan 1990
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