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TINA-QUANT Apolipoprotein B VER.2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013207

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K013207 FDA 510(k)
FDA Product Code
DFC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5600 FDA 510(k)
Regulation Number
866.5600 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TINA-QUANT Apolipoprotein B VER.2 is an in vitro diagnostic reagent system for the quantitative determination of apolipoprotein B in human serum and plasma. It is designed for use on Roche/Hitachi cobas c systems and operates via immunoturbidimetric assay to measure apolipoprotein B levels.

This device is supplied as a test kit for use with cobas c 311/501 analyzers (ACN 151) and cobas c 502 analyzer (ACN 8151). It is a single-use device with FDA 510(k) clearance (K013207) and is classified under product code DFC for immunology testing. The device is stored according to manufacturer specifications and requires appropriate laboratory conditions for proper use.

Frequently asked questions

What is the TINA-QUANT Apolipoprotein B VER.2 used for?

The TINA-QUANT Apolipoprotein B VER.2 is an in vitro diagnostic reagent system designed for the quantitative determination of apolipoprotein B in human serum and plasma, primarily used for cardiovascular risk assessment.

Which analyzers is this device compatible with?

This device is specifically designed for use on Roche/Hitachi cobas c systems, including the cobas c 311/501 analyzers (ACN 151) and cobas c 502 analyzer (ACN 8151).

Is the TINA-QUANT Apolipoprotein B VER.2 a single-use device?

Yes, this device is supplied as a single-use test kit and is not intended for reuse. Each kit should be used according to the manufacturer's instructions for accurate results.

What are the storage requirements for this diagnostic reagent?

The device should be stored according to manufacturer specifications in appropriate laboratory conditions to maintain its integrity and ensure accurate test results. Specific temperature and handling requirements should be followed as per the product documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: method-sheet-cobas - Roche, TINA-QUANT APOLIPOPROTEIN B VER.2 (K013207) — FDA 510(k) | Innolitics, ROCHE COBAS Apolipoprotein B ver.2 (APOBT) (100 Test ), Tina-quant Apolipoprotein B ver.2 08105464190 GUDID… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K013207 24 fields · synced Oct 1, 2026