Cleared Traditional

K031650 - FERRITIN GENERATION 2

K031650 is the FDA 510(k) clearance for FERRITIN GENERATION 2 by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K031650 · Roche Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
50d
Days
Class 2
Risk

K031650 is an FDA 510(k) clearance for the FERRITIN GENERATION 2. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2003 after a review of 50 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K031650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date July 17, 2003
Days to Decision 50 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
54d faster than avg
Panel avg: 104d · This submission: 50d
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 47
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K031650.
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
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