Cleared Traditional

K915463 - ACTIVATED PARTIAL THROMBOPLASTIN TIME

K915463 is the FDA 510(k) clearance for ACTIVATED PARTIAL THROMBOPLASTIN TIME by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGW) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K915463 · Sigma Diagnostics, Inc. · Hematology device
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Jan 1992
Decision
50d
Days
Class 2
Risk

K915463 is an FDA 510(k) clearance for the ACTIVATED PARTIAL THROMBOPLASTIN TIME. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 50 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K915463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date January 23, 1992
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGW Test, Time, 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 - GGW Test, Time, Partial Thromboplastin

All 20
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K915463.
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PLATELET EXTRACT REAGENT
K873382 · Bio/Data Corp. · Nov 1987
ACTIN FSL ACTIVATED PTT REAGENT
K863594 · American Dade · Oct 1986