Cleared Traditional

K171642 - Atellica IM Ferritin Assay

K171642 is an FDA 510(k) clearance for Atellica IM Ferritin Assay, 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 90-day FDA review.

K171642 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Aug 2017
Decision
90d
Days
Class 2
Risk

K171642 is an FDA 510(k) clearance for the Atellica IM Ferritin Assay. 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 31, 2017 after a review of 90 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.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K171642

510(k) Number K171642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date August 31, 2017
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
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 K171642.
LIAISON Ferritin
K193650 · DiaSorin, Inc. · Sep 2021
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
K191562 · HORIBA ABX SAS · Mar 2020
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
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010