WIENER LAB. UREA UV CINETICA AA

• K Number: K012260
• Device Name: WIENER LAB. UREA UV CINETICA AA
• Manufacturer: WIENER LABORATORIES S.A.I.C.
• Date Cleared: 2001-09-19 ( 63 days)
• Product Code: CDQ
• Regulation Number: 862.1770
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The UREA UV CINETICA AA test system is intended to be used in the quantitative determination of urea in human serum and plasma. Urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

Kinetic method.
The device is based on the following reaction system:
Urease
Urea + H2O --------> 2 NH3 + CO2
NH3 + NADH + H+ + 2-oxoglutarate --------> I-glutamate + NAD+ + H2O

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Wiener lab. UREA UV CINETICA AA" test system, and its substantial equivalence to a predicate device, the "DMA BUN-KINETIC, UREASE PROCEDURE test system." It outlines the device's intended use, principle, and various performance characteristics.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense, but rather presents a comparison of the performance characteristics of the proposed device ("WIENER LAB. Test System") against a predicate device ("DMA Test System"). The implicit acceptance criterion is that the Wiener Lab device demonstrates comparable or improved performance relative to the predicate device.

Here's a table summarizing the reported device performance compared to the predicate device:

Performance Characteristic	Predicate Device (DMA Test System)	Proposed Device (WIENER LAB. Test System)
Intended Use	Quantitative determination of urea in human serum and plasma.	Quantitative determination of urea in human serum and plasma. (Same)
Test Principle	Kinetic method, Urease/GIDH reaction system.	Kinetic method, Urease/GIDH reaction system. (Same)
Essential Components	2-Oxoglutarate - NADH - Urease - GIDH.	2-Oxoglutarate - NADH - Urease - GIDH. (Same)
Working Reagent Stability	14 days	30 days
Instability/Deterioration of Reagents (Reagent Blank Absorbance)

Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.