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Modification to Integra Reagent Cassette for Hemoglobin A1C

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003120

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K003120 FDA 510(k)
FDA Product Code
LCP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7470 FDA 510(k)
Regulation Number
864.7470 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an in vitro diagnostic reagent system used on the INTEGRA family of analyzers. It performs an immunoturbidimetric test for HbA1c and a colorimetric test for total hemoglobin. The device automates the preparation of hemolysate from anticoagulated venous or capillary whole blood samples.

The analyzer uses spectrophotometric measurement to determine results. It is supplied as a reagent cassette for use with the INTEGRA analyzer system. The device received FDA 510(k) clearance (K003120) on December 18, 2000, and is classified as Class II under product code LCP with regulation number 864.7470.

Frequently asked questions

What is the MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C used for?

This device is an in vitro diagnostic reagent system used on INTEGA analyzers to perform immunoturbidimetric tests for HbA1c and colorimetric tests for total hemoglobin. It automates hemolysate preparation from anticoagulated venous or capillary whole blood samples.

How is the MODIFICATION TO INTEGRA REAGENT CASSETTE supplied?

The device is supplied as a reagent cassette specifically designed for use with the INTEGA analyzer system. It is not supplied as a standalone product but as a component that integrates with the analyzer platform.

What is the regulatory status of this device?

The device received FDA 510(k) clearance with number K003120 on December 18, 2000. It is classified as Class II under product code LCP with regulation number 864.7470, indicating it meets specific FDA safety and effectiveness requirements.

What types of blood samples can be used with this reagent cassette?

The device can process anticoagulated venous or capillary whole blood samples. It automates the preparation of hemolysate from these samples for subsequent analysis of HbA1c and total hemoglobin levels.

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: K003120 FDA 510(k) - MODIFICATION TO INTEGRA REAGENT CASSETT..., PDF K003120 Modification to Integra Reagent Cassette for Hemoglobin A1c, INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC (K990992) — FDA 510(k ..., Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin (K961824 ...

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) K003120 24 fields · synced Sep 27, 2026