Cleared Traditional

K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050944 · Kamiya Biomedical Co. · Immunology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 104d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K050944.
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QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
N LATEX FERRITIN
K993273 · Dade Behring, Inc. · Nov 1999
ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998