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Abx Pentra Glucose Hk Cp, Urea Cp, Uric Acid Cp

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K070146

by Horiba Abx

Identifiers

510(k) Number
K070146 FDA 510(k)
FDA Product Code
CDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1770 FDA 510(k)
Regulation Number
862.1770 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ABX Pentra Glucose HK CP, Urea CP, Uric Acid CP is a reagent for in vitro diagnostic use, designed for quantitative colorimetric analysis of glucose, urea, and uric acid in human serum, plasma, and urine. It employs enzymatic methods—glucose hexokinase for glucose, urease for urea, and uricase for uric acid—to measure these analytes, supporting clinical chemistry applications in metabolic and renal assessments.

This reagent is supplied as a liquid chemistry product, intended for use with the ABX Pentra 400 analyzer. It is classified under IVDR and FDA 510(k) clearance (K070146) as a Class II device, adhering to regulatory standards for in vitro diagnostics. The product is single-use, requiring proper storage as specified by the manufacturer to maintain stability and performance. No MRI safety or reusable components are indicated.

Frequently asked questions

What clinical chemistry applications does this reagent support, and how does it measure the target analytes?

This reagent supports metabolic and renal assessments by enabling quantitative colorimetric analysis of glucose, urea, and uric acid in human serum, plasma, and urine. It uses enzymatic methods: glucose hexokinase for glucose measurement, urease for urea, and uricase for uric acid, ensuring accurate and reliable results for clinical decision-making.

Is this reagent compatible with any specific analyzer, and how is it supplied?

Yes, this reagent is specifically designed for use with the ABX Pentra 400 analyzer. It is supplied as a liquid chemistry product, intended for single-use only to maintain performance and sterility.

What storage requirements should be followed to ensure the reagent remains stable and effective?

The manufacturer specifies proper storage conditions to preserve stability and performance, though exact details (e.g., temperature, light exposure) are not provided in the data. Always refer to the included instructions or contact Horiba Abx for precise storage guidelines.

Is this reagent reusable, or is it intended for single-use only?

This reagent is intended for single-use only, as explicitly stated in the device description. Reuse is not recommended to ensure accuracy, sterility, and compliance with regulatory standards.

What regulatory pathways does this reagent follow, and what class designation does it hold?

The reagent is cleared under FDA 510(k) (K070146) and classified under the In Vitro Diagnostic Regulation (IVDR) as a Class II device. It was determined substantially equivalent to a predicate device by the FDA’s Clinical Chemistry advisory committee, adhering to strict regulatory standards for in vitro diagnostics.

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: ABX Pentra Glucose HK CP - toolkits.horiba-abx.com, ABX Pentra 400 Reagents - HORIBA, ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (K070146) — FDA 510(k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Horiba Abx

Sources (2)

  • FDA 510(k) K070146 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026