Cleared Traditional

K110736 - ADVIA CHEMISTRY FERRITIN (FRT) METHOD

K110736 is an FDA 510(k) clearance for ADVIA CHEMISTRY FERRITIN (FRT) METHOD, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K110736 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Aug 2011
Decision
154d
Days
Class 2
Risk

K110736 is an FDA 510(k) clearance for the ADVIA CHEMISTRY FERRITIN (FRT) METHOD. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 17, 2011 after a review of 154 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K110736

510(k) Number K110736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date August 17, 2011
Days to Decision 154 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
49d slower than avg
Panel avg: 105d · This submission: 154d
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 74
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K110736.
Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc. · Aug 2017
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
K133083 · Diazyme Laboratories · Jun 2014
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
K121232 · Kamiya Biomedical Company · May 2012
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
RDI HSFERRITIN KIT
K053211 · Reference Diagnostics, Inc. · Mar 2006