Cleared Traditional

K040362 - DIAPHARMA FACTOR X KIT

K040362 is an FDA 510(k) clearance for DIAPHARMA FACTOR X KIT, manufactured by Diapharma Group, Inc.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K040362 · Diapharma Group, Inc. · Hematology device
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Jul 2004
Decision
150d
Days
Class 2
Risk

K040362 is an FDA 510(k) clearance for the DIAPHARMA FACTOR X KIT. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Diapharma Group, Inc. (West Chester, US). The FDA issued a Cleared decision on July 12, 2004 after a review of 150 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Diapharma Group, Inc. devices

FDA 510(k) Submission Details - K040362

510(k) Number K040362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2004
Decision Date July 12, 2004
Days to Decision 150 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 113d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJT Device Classification - Class 2, Special Controls

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 75
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K040362.
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · Instrumentation Laboratory CO · Jul 2011
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · Instrumentation Laboratory CO · May 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · Instrumentation Laboratory CO · Feb 2005
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · Instrumentation Laboratory CO · Feb 2004
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · Instrumentation Laboratory CO · Jul 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · Instrumentation Laboratory CO · May 2003