Cleared Traditional

K193650 - LIAISON Ferritin

K193650 is an FDA 510(k) clearance for LIAISON Ferritin, manufactured by DiaSorin, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K193650 · DiaSorin, Inc. · Immunology device
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Sep 2021
Decision
624d
Days
Class 2
Risk

K193650 is an FDA 510(k) clearance for the LIAISON Ferritin. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 14, 2021 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all DiaSorin, Inc. devices

FDA 510(k) Submission Details - K193650

510(k) Number K193650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date September 14, 2021
Days to Decision 624 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
519d slower than avg
Panel avg: 105d · This submission: 624d
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 73
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K193650.
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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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
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010