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510(k) Data Aggregation
(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 (<1 micromole/Liter). |
| Value Assignment | Values assigned by gravimetric composition. Confirmed in accordance with Thermo Trace Ammonia Standard Production Specification document number PS345/00. |
| Lot-to-Lot Consistency | Each lot of standard is tested with Thermo Trace Ammonia DST reagent, using a previously approved standard lot as a control. |
| Accuracy/Traceability | Commercially available controls (Roche Preciset NH3) are included in the verification assay to serve as additional controls on the accuracy of the standard material on an ongoing basis. |
| Stability/Shelf Life | Product stability determined by performing accelerated stability studies (stressed at three temperatures for a pre-defined period). Real-time testing is conducted to further validate the established dating. Real-time data collection is ongoing. |
| Instrument Compatibility | Analytical use of the Cobas Mira in testing this product(s) is described in procedure number PS345/00. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm evaluation. Instead, the performance and value assignment are based on quality control and validation procedures for each lot of the standard.
- Test Set Sample Size: Not applicable in the context of an AI device. The document mentions "each lot of standard" being tested.
- Data Provenance: The studies are internal to Thermo DMA and involve laboratory testing of manufactured standards. The data is prospective for ongoing quality control and stability monitoring. The country of origin is implicitly the USA (Thermo DMA, Arlington, TX).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of an AI device. The "ground truth" for these chemical standards is established through gravimetric composition and analytical testing, overseen by qualified laboratory personnel and conforming to internal specifications.
4. Adjudication Method for the Test Set
Not applicable as this is not an AI device or a diagnostic study requiring expert adjudication of results. The "adjudication" is based on adherence to predefined chemical and analytical specifications (e.g., PS345/00, PS3435/00).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a chemical standard set, not an AI diagnostic tool that requires human interpretation or assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not an algorithm-based device. The "performance" is intrinsic to the accuracy and stability of the chemical composition of the standards. The validation involves analytical testing of these standards.
7. The Type of Ground Truth Used
The ground truth for the value assignment and composition of the standards is based on:
- Gravimetric Composition: Accurately weighing the specified amount of Anhydrous Ammonium Sulfate.
- Reference Materials: Testing against previously approved standard lots and commercially available controls (Roche Preciset NH3).
- Analytical Specifications: Adherence to defined production specification documents (e.g., PS345/00).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a training set. The "training" in a broad sense involves the processes and procedures established for manufacturing and quality control.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI device. The "ground truth" for the production and quality control processes is based on established chemical principles, gravimetric measurements, and analytical validation against reference materials and internal specifications.
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