Cleared Traditional

K050365 - BIOPHEN PROTEIN C5

K050365 is the FDA 510(k) clearance for BIOPHEN PROTEIN C5 by Hyphen Biomed. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K050365 · Hyphen Biomed · Hematology device
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Dec 2005
Decision
316d
Days
Class 2
Risk

K050365 is an FDA 510(k) clearance for the BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on December 27, 2005 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K050365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date December 27, 2005
Days to Decision 316 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
203d slower than avg
Panel avg: 113d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K050365.
TRIAGE PROTEIN C TEST
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K062430 · Instrumentation Laboratory CO · Sep 2006
HEMOSIL PROS
K053499 · Instrumentation Laboratory CO · Jan 2006
COATEST SP FVIII
K042576 · Instrumentation Laboratory CO · Dec 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · Instrumentation Laboratory CO · Apr 2004
MODIFICATION TO COATEST FACTOR VIII
K033631 · Instrumentation Laboratory CO · Dec 2003