PARAMAX AMMONIA AND AMMONIA BLANK REAGENT

K964565 · Dade Intl., Inc. · JIF · Nov 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964565
• Device Name: PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
• Applicant: Dade Intl., Inc.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The Paramax® Ammonia and Ammonia Blank Reagent are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.

Device Story

In vitro diagnostic reagent; utilizes GLDH enzymatic method for quantitative ammonia measurement in plasma; used on Paramax® clinical chemistry systems; provides quantitative results to clinicians for assessment of ammonia levels; aids in diagnosis and monitoring of metabolic conditions; performance validated via correlation with predicate system.

Clinical Evidence

Bench testing only. Comparison study of 197 plasma samples between Paramax® and DuPont aca systems. Correlation coefficient 0.986; regression equation: Paramax® = (0.980 * aca) - 8.8.

Technological Characteristics

GLDH enzymatic reagent system for quantitative ammonia determination. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of ammonia and ammonia blank in human plasma.

Regulatory Classification

Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Predicate Devices

• DuPont aca Ammonia and Ammonia Blank Reagent (K770363)

Submission Summary (Full Text)

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K964565
Nov. 22, 1996

# 510(k) Summary of Safety and Effectiveness Information

The Paramax® Ammonia and Ammonia Blank Reagent is substantially equivalent to its predecessor, which was cleared to market on K770363. The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.

The Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent are GLDH enzymatic method.

The technological characteristics of the predicate device are similar to those previously described for the proposed device.

The correlation between the Paramax® Ammonia and Ammonia Blank Reagent and DuPont aca Ammonia and Ammonia Blank Reagent was demonstrated by testing 197 samples on a Paramax® and DuPont aca Systems. The correlation coefficient was 0.986, and the regression equation was Paramax® value = (0.980X *aca value) -8.8. The data indicates that the results obtained by both reagents are substantially equivalent.

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