Cleared Traditional

K955638 - SYNTHAFAX APTT REAGENT

K955638 is an FDA 510(k) clearance for SYNTHAFAX APTT REAGENT, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K955638 · Ortho Diagnostic Systems, Inc. · Hematology device
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Apr 1996
Decision
134d
Days
Class 2
Risk

K955638 is an FDA 510(k) clearance for the SYNTHAFAX APTT REAGENT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 134 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K955638

510(k) Number K955638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date April 23, 1996
Days to Decision 134 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
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K955638.
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp. · Nov 1997
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997
SPECKTIN-LA TEST SET
K961892 · Analytical Control Systems, Inc. · Mar 1997
PATHROMTIN SL
K955450 · Behring Diagnostics, Inc. · Apr 1996
SYNTHASIL APTT REAGENT
K953981 · Ortho Diagnostic Systems, Inc. · Nov 1995
APTT-ES
K935169 · Helena Laboratories · Dec 1994