Cleared Traditional

K053211 - RDI HSFERRITIN KIT

K053211 is an FDA 510(k) clearance for RDI HSFERRITIN KIT, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K053211 · Reference Diagnostics, Inc. · Immunology device
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Mar 2006
Decision
117d
Days
Class 2
Risk

K053211 is an FDA 510(k) clearance for the RDI HSFERRITIN KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on March 13, 2006 after a review of 117 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K053211

510(k) Number K053211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date March 13, 2006
Days to Decision 117 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
12d slower than avg
Panel avg: 105d · This submission: 117d
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 77
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K053211.
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
K062746 · Medicon Hellas S.A · Nov 2006
FERRITIN LIT ASSAY, CATALOG NO. 7010
K052617 · Good Biotech Corp. · Feb 2006
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · Kamiya Biomedical Co. · Dec 2005
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
K053211 · RDI HSFERRITIN KIT
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