Cleared Traditional

K042762 - PEFAKIT APC-R FACTOR V LEIDEN

K042762 is the FDA 510(k) clearance for PEFAKIT APC-R FACTOR V LEIDEN by Pentapharm , Ltd.. It is a Class 2 Hematology device (product code GGW) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K042762 · Pentapharm , Ltd. · Hematology device
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Optimized for regulatory review, auditing and printing
Dec 2004
Decision
78d
Days
Class 2
Risk

K042762 is an FDA 510(k) clearance for the PEFAKIT APC-R FACTOR V LEIDEN. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Pentapharm , Ltd. (Washington, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 78 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 Pentapharm , Ltd. devices

Submission Details

510(k) Number K042762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date December 22, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
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 21
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