Cleared Traditional

K904341 - APTT REAGENT

K904341 is the FDA 510(k) clearance for APTT REAGENT by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K904341 · Sigma Chemical Co. · Hematology device
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Nov 1990
Decision
49d
Days
Class 2
Risk

K904341 is an FDA 510(k) clearance for the APTT REAGENT. 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 November 8, 1990 after a review of 49 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 K904341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date November 08, 1990
Days to Decision 49 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
64d faster than avg
Panel avg: 113d · This submission: 49d
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 K904341.
ELLAGIC ACID APTT REAGENT
K915418 · Helena Laboratories · Feb 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · International Technidyne Corp. · Feb 1992
HEMOCHRON(R) APTT, MODIFICATION
K911994 · International Technidyne Corp. · Jul 1991
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
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545 · Sigma Chemical Co. · Dec 1989