Cleared Traditional

K133083 - DIAZYME FERRITIN ASSAY

K133083 is an FDA 510(k) clearance for DIAZYME FERRITIN ASSAY, manufactured by Diazyme Laboratories. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K133083 · Diazyme Laboratories · Immunology device
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Jun 2014
Decision
267d
Days
Class 2
Risk

K133083 is an FDA 510(k) clearance for the DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CON.... Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on June 24, 2014 after a review of 267 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K133083

510(k) Number K133083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 24, 2014
Days to Decision 267 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
163d slower than avg
Panel avg: 104d · This submission: 267d
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 68
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K133083.
LIAISON Ferritin
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Atellica IM Ferritin Assay
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ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009