Cleared Traditional

K040879 - QUANTEX FERRITIN

K040879 is an FDA 510(k) clearance for QUANTEX FERRITIN, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K040879 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
35d
Days
Class 2
Risk

K040879 is an FDA 510(k) clearance for the QUANTEX FERRITIN. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 10, 2004 after a review of 35 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K040879

510(k) Number K040879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date May 10, 2004
Days to Decision 35 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
70d faster than avg
Panel avg: 105d · This submission: 35d
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 72
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K040879.
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
RDI HSFERRITIN KIT
K053211 · Reference Diagnostics, Inc. · Mar 2006
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · Kamiya Biomedical Co. · Dec 2005
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp. · Jul 2003
OLYMPUS FERRITIN REAGENT
K030124 · Olympus America, Inc. · Feb 2003
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · Kamiya Biomedical Co. · Feb 2002