Cleared Traditional

K050448 - CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

K050448 is an FDA 510(k) clearance for CHROMOPEP PC, manufactured by Horiba Abx. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K050448 · Horiba Abx · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
213d
Days
Class 2
Risk

K050448 is an FDA 510(k) clearance for the CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on September 23, 2005 after a review of 213 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 Horiba Abx devices

FDA 510(k) Submission Details - K050448

510(k) Number K050448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date September 23, 2005
Days to Decision 213 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
100d slower than avg
Panel avg: 113d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

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 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K050448.
HEMOSIL PROTEIN C
K062430 · Instrumentation Laboratory CO · Sep 2006
HEMOSIL PROS
K053499 · Instrumentation Laboratory CO · Jan 2006
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
K050365 · Hyphen Biomed · Dec 2005
VISULIZE FACTOR IX ANTIGEN KIT
K051054 · Affinity Biologicals, Inc. · Jun 2005
CRYOCHECK CLOT S
K043571 · Precision Biologic, Inc. · Mar 2005
COATEST SP FVIII
K042576 · Instrumentation Laboratory CO · Dec 2004