(34 days)
The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyzers. For in vitro diagnostic use only.
The Bicarbonate Calibrator kit is a two level aqueous preparation of sodium carbonate intended to provide calibration for the Bicarbonate reagent for the calibration of bicarbonate on Beckman AU Coulter analyzers. This is available in the following configurations Cat # OSR6137, OSR6237 and OSR6537. For convenience this is often referred to internally and externally as OSR6x37. The following is the kit configuration for the Bicarbonate Calibrator: ODC0019 has 3 vials with 25ml contents for Level 1 and 3 vials with 25ml for Level 2. The Bicarbonate Calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The calibrator contains sodium o-phenylphenate tetrahydrate which acts as a preservative.
The provided text describes the acceptance criteria and the study for the Beckman Coulter Bicarbonate Calibrator.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Support claim of 30 days @ 15-25°C. Controls within target range & precision claims (≤ 3% or SD ≤1mEq/L). | 30 days @ 15-25°C. Testing performed with 3 calibrator lots, multiple time points. Controls recovered within target ranges and met precision claims (≤ 3% or SD ≤1mEq/L). (Specific numerical data not provided, but overall claim supported). |
| Shelf Life Stability | Support claim of 13 months @ 15-25°C. Controls within target range & precision claims (≤ 3% or SD ≤1mEq/L). | 13 months @ 15-25°C. Real-time stability testing on 3 lots at multiple time points. Controls recovered within target ranges and met precision claims (≤ 3% or SD ≤1mEq/L). Tested for 13 months plus at least one month after expiration. (Specific numerical data not provided, but overall claim supported). |
| Value Assignment | Maximum allowable deviation of ±5% from assigned targets. | Test calibrator and NIST SRM 351 standard run (n=10). (Specific numerical deviations not provided, but the criterion was applied). |
| Traceability | Maximum allowable deviation of ±5% from assigned targets. | NIST351 standard and test calibrator recovered (n=10) when tested with reference calibrator. (Specific numerical deviations not provided, but the criterion was applied). |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Stability Studies: Open vial and shelf life stability used "3 individual calibrator lots" for testing. "Multiple time points" were used during the claim period and beyond. For each time point, controls were run in "replicates of 5" and test vials were compared with "freshly opened calibrator vial."
- Value Assignment and Traceability: "A sample from test calibrator and NIST SRM 351 standard was run (n=10)." and "NIST351 standard and test calibrator recovered (n=10)."
- Data Provenance: The studies were conducted by Beckman Coulter Ireland, Inc. and Beckman Coulter in the USA. The data appears to be prospective as it involves real-time stability testing and direct experimental runs for value assignment and traceability. No specific mention of country of origin for patients or samples, as this is a calibrator, not a diagnostic device using patient samples directly.
3. Number of Experts and Qualifications
Not applicable. This device is a calibrator, not a medical imaging device or algorithm requiring expert interpretation of results. The performance is assessed against analytical standards and established methods, not human expert consensus on clinical data.
4. Adjudication Method
Not applicable. This is an analytical device for calibration, not a diagnostic device requiring adjudication of clinical interpretations. Performance is determined by quantitative analytical results meeting predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a calibrator, not a diagnostic device that humans would interpret with or without AI assistance.
6. Standalone Performance Study
Yes, the studies described above are standalone performance studies of the calibrator itself. The calibrator's performance (stability, value assignment, traceability) is assessed independently of a human operator making clinical decisions. The calibrator's function is to ensure the accuracy of the Beckman Coulter AU analyzers when running the Bicarbonate reagent.
7. Type of Ground Truth Used
- Stability Studies: The ground truth is the performance of the calibrator itself over time, compared to its initial established values and against the performance of freshly opened calibrator vials or within predefined control ranges and precision claims. The "appropriate control material" with "target ranges and precision claims" serves as a reference.
- Value Assignment and Traceability: The ground truth is established by the NIST (National Institute of Standards and Technology) SRM351 standard. This is a highly accurate, internationally recognized reference material for bicarbonate. The calibrator's values are directly traced to this gold standard.
8. Sample Size for the Training Set
Not applicable. This is a chemical calibrator for in vitro diagnostics, not a machine learning or AI algorithm that requires a training set. Its formulation is based on chemical principles and manufacturing processes, not data training.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this type of device.
§ 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.