(49 days)
Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na', K', and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.
Diamond Tokyo Boeki Calibrators are intended to serve as a direct replacement to Tokyo Boeki ISE Calibrators. Diamond Tokyo Boeki ISE Module calibrators are intended to provide calibration points for the Na*, K*, and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, Sapphire 400, Sirrus, TMS-1024i, TRX-7010 and Labmax 240 instruments in both Human Serum and Human Urine modes.
Diamond Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 420 ml of solution.
Diamond Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 20 ml of solution.
Diamond Urine Calibrator is comprised of Urine Calibrator 1 and 2 which are not sold separately. Each box contains 10 ampules of Calibrator 1 in a tray and 10 ampules of Calibrator 2 in a separate tray.
Diamond Urine Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
Diamond Urine Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
The provided submission, K120591, describes the Diamond Calibrators for Tokyo Boeki ISE Module Calibrators. This is a medical device for in-vitro diagnostics. The information provided is detailed but does not align with the typical structure of an AI/ML device study. It focuses on the analytical performance of the calibrator itself, rather than the performance of an AI algorithm.
Therefore, many of the requested sections about AI/ML device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.
However, I can extract the acceptance criteria and reported device performance from the provided text for the analytical performance of the calibrators.
Acceptance Criteria and Reported Device Performance
Device: Diamond Calibrators for Tokyo Boeki ISE Module Calibrators
Intended Use: To provide calibration points for Na+, K+, and Cl- electrodes on specific Tokyo Boeki instruments in both Human Serum and Human Urine modes.
Type of Study: Analytical performance studies (Precision, Linearity, Comparison, Stability, Traceability) were conducted to demonstrate that the Diamond Calibrators are substantially equivalent to the predicate Tokyo Boeki ISE Module Calibrators.
Ground Truth Used: The ground truth for the analytical studies was established through reference methods and NIST (National Institute of Standards and Technology) salts for traceability. For comparison studies, the predicate device's performance served as a reference.
Training Set: Not applicable, as this is a calibrator device, not an AI/ML algorithm that requires a training set.
Summary of Acceptance Criteria and Reported Device Performance:
| Study Category | Analyte | Matrix | Acceptance Criteria (Specification) | Reported Device Performance (Example Values) | Outcome |
|---|---|---|---|---|---|
| Precision (Within Run) | Na+ | Serum | %CV |
§ 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.