Cleared Traditional

K014293 - K-ASSAY FERRITIN

K014293 is the FDA 510(k) clearance for K-ASSAY FERRITIN by Kamiya Biomedical Co.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K014293 · Kamiya Biomedical Co. · Immunology device
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Feb 2002
Decision
53d
Days
Class 2
Risk

K014293 is an FDA 510(k) clearance for the K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on February 19, 2002 after a review of 53 days - a notably fast clearance 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: 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K014293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2001
Decision Date February 19, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 104d · This submission: 53d
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 54
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K014293.
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
RANDOX FERRITIN
K000662 · Randox Laboratories, Ltd. · Apr 2000
N LATEX FERRITIN
K993273 · Dade Behring, Inc. · Nov 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
K984186 · Nichols Institute Diagnostics · Feb 1999