Cleared Traditional

K190495 - Transferrin

K190495 is an FDA 510(k) clearance for Transferrin, manufactured by Biosystems S.A.. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K190495 · Biosystems S.A. · Immunology device
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Mar 2020
Decision
382d
Days
Class 2
Risk

K190495 is an FDA 510(k) clearance for the Transferrin. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on March 16, 2020 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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. Elevated predicate reliance profile. 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 Biosystems S.A. devices

FDA 510(k) Submission Details - K190495

510(k) Number K190495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2019
Decision Date March 16, 2020
Days to Decision 382 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
277d slower than avg
Panel avg: 105d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K190495.
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K182095 · Roche Diagnostics Operations (Rdo) · Nov 2018
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K120236 · The Binding Site Group , Ltd. · Feb 2013
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K080634 · Beckman Coulter, Inc. · Aug 2008
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K081299 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K063663 · Dade Behring, Inc. · Mar 2007