Cleared Traditional

K101203 - TINA-QUANT ALBUMIN GEN 2

K101203 is an FDA 510(k) clearance for TINA-QUANT ALBUMIN GEN 2, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code DCF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K101203 · Roche Diagnostics · Chemistry device
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Sep 2010
Decision
134d
Days
Class 2
Risk

K101203 is an FDA 510(k) clearance for the TINA-QUANT ALBUMIN GEN 2. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K101203

510(k) Number K101203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2010
Decision Date September 10, 2010
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCF Albumin, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K101203.
HUMAN ALBUMIN CSF KIT
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TINA-QUANT ALBUMIN GEN.2
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K091486 · Kamiya Biomedical Co. · Apr 2010
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
K082251 · Beckman Coulter, Inc. · Apr 2009