(61 days)
The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems.
The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE.
The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems.
The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.
pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system.
The pHoenix ISE Reagents for Roche/Hitachi Models 700/900 Series were determined to be substantially equivalent to predicate devices manufactured by Roche Diagnostics Corporation based on method comparison and precision studies.
1. A table of acceptance criteria and the reported device performance
The provided text describes performance equivalence in general terms (method comparison and precision study) but does not contain a detailed table of specific acceptance criteria (e.g., specific ranges for bias or precision) or the reported device performance values. It states these reagents are "similar in composition and performance" to Roche Diagnostics equivalents and "have shown performance equivalence."
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case comparative effectiveness study is not applicable as this device is a reagent for in vitro diagnostic testing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a reagent, not an algorithm. The performance evaluation would be for the reagent's analytical accuracy and precision when used with the specified instruments.
7. The type of ground truth used
The ground truth for evaluating the pHoenix ISE Reagents would likely be established through:
- Reference Method Comparison: Comparing the results obtained using the pHoenix ISE Reagents with those obtained from the predicate device (Roche Diagnostics equivalents) or an established reference method.
- Known Concentration Standards: Using samples with accurately known concentrations of Na+, K+, and Cl- to assess the accuracy of the measurements.
8. The sample size for the training set
This information is not provided, and the concept of a "training set" in the context of analytical reagent performance testing (as opposed to machine learning) is generally not applicable in the same way. Performance studies for reagents typically involve testing across a range of concentrations and conditions to characterize their analytical performance.
9. How the ground truth for the training set was established
As noted above, a "training set" as understood in machine learning is not directly applicable here. For the performance studies, the ground truth would be established by comparing against the predicate device's performance characteristics or recognized analytical standards.
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.