Cleared Traditional

K182095 - Tina-quant Transferrin ver.2 (urine app...

K182095 is the FDA 510(k) clearance for Tina-quant Transferrin ver.2 (urine app... by Roche Diagnostics Operations (Rdo). It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K182095 · Roche Diagnostics Operations (Rdo) · Immunology device
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Nov 2018
Decision
94d
Days
Class 2
Risk

K182095 is an FDA 510(k) clearance for the Tina-quant Transferrin ver.2 (urine application). Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on November 5, 2018 after a review of 94 days - within the typical 510(k) review window.

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. 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 Roche Diagnostics Operations (Rdo) devices

Submission Details

510(k) Number K182095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date November 05, 2018
Days to Decision 94 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
10d faster than avg
Panel avg: 104d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K182095.
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K063663 · Dade Behring, Inc. · Mar 2007
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