Cleared Traditional

K955450 - PATHROMTIN SL

K955450 is the FDA 510(k) clearance for PATHROMTIN SL by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K955450 · Behring Diagnostics, Inc. · Hematology device
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Apr 1996
Decision
142d
Days
Class 2
Risk

K955450 is an FDA 510(k) clearance for the PATHROMTIN SL. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K955450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date April 19, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
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 K955450.
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997
SPECKTIN-LA TEST SET
K961892 · Analytical Control Systems, Inc. · Mar 1997
SYNTHAFAX APTT REAGENT
K955638 · Ortho Diagnostic Systems, Inc. · Apr 1996
SYNTHASIL APTT REAGENT
K953981 · Ortho Diagnostic Systems, Inc. · Nov 1995
APTT-ES
K935169 · Helena Laboratories · Dec 1994
APTT-ES REAGENT
K934351 · Medical Diagnostic Technologies, Inc. · Dec 1993