Cleared Traditional

K050944 - K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET

K050944 is an FDA 510(k) clearance for K-ASSAY FERRITIN (2) & FERRITIN CALIBRA..., manufactured by Kamiya Biomedical Co.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K050944 · Kamiya Biomedical Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
253d
Days
Class 2
Risk

K050944 is an FDA 510(k) clearance for the K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on December 23, 2005 after a review of 253 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kamiya Biomedical Co. devices

FDA 510(k) Submission Details - K050944

510(k) Number K050944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date December 23, 2005
Days to Decision 253 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 105d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 73
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K050944.
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
RDI HSFERRITIN KIT
K053211 · Reference Diagnostics, Inc. · Mar 2006
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp. · Jul 2003
OLYMPUS FERRITIN REAGENT
K030124 · Olympus America, Inc. · Feb 2003