(49 days)
This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
This document describes the Thermo Trace Ammonia Standards Set, which is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent to establish points of reference for the determination of Ammonia in human plasma.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes the process for establishing and validating the values of the Thermo Trace Ammonia Standards Set rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. Instead, the "acceptance criteria" are implied by the methods used to ensure the quality and accuracy of the standards.
| Acceptance Criteria (Implied) | Reported Device Performance/Method of Verification |
|---|---|
| Purity/Composition | Specified amount of Anhydrous Ammonium Sulfate accurately weighed on a calibrated analytical balance and dissolved in Class A volumetric flask with ammonia-free deionized water ( |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.