(78 days)
The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.
The BILI calibrator is a two level calibrator. Level 1, purified system water, is provided on-board the Dimension Vista® System. Level 2 is a liquid, bovine serum albumin based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
This 510(k) summary describes a calibrator device, not a diagnostic device that processes patient data. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable as they pertain to the evaluation of diagnostic performance on patient samples.
The document focuses on demonstrating substantial equivalence to a predicate calibrator.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the calibrator's performance against specific metrics (e.g., accuracy, precision). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing attributes. The "performance" reported primarily relates to the characteristics of the calibrator itself rather than measured performance in a study against acceptance criteria.
| Attribute | Predicate Device (TDBIL Calibrator) Reported Performance | Proposed Device (BILI Calibrator) Reported Performance |
|---|---|---|
| Intended Use | Calibration of DBIL and TBIL methods on Dimension Vista™ System | Calibration of DBIL and TBIL methods on Dimension Vista® System |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human Serum | Bovine Serum |
| Levels | One (CAL A) + on-board purified system water (Level 1) | One (CAL A) + on-board purified system water (Level 1) |
| Bilirubin Conc. Level 2 (Total, mg/dL) | 27.5 | 27.5 |
| Bilirubin Conc. Level 2 (Direct, mg/dL) | 19.25 | 17.5 |
| Form | Lyophilized | Liquid |
| Volume | 3 vials, 1 mL each (hydrated) | 3 vials, 2.5 mL each |
| Traceability | NIST SRM 916a | NIST SRM 916a |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a calibrator, not a diagnostic device evaluated on patient samples. The document focuses on the characteristics of the calibrator itself and its substantial equivalence to a predicate calibrator. There is no "test set" of patient data in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See explanation above. The ground truth for the calibrator's concentration is established by traceability to NIST Standard Reference Material 916a, not by expert consensus on biological samples.
4. Adjudication method for the test set
- Not Applicable. See explanation above.
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
- Not Applicable. This is a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a calibrator; there is no "algorithm" in the sense of a diagnostic interpretation model.
7. The type of ground truth used
- For the calibrator values: The calibrator's values are traceable to NIST Standard Reference Material (SRM) 916a. This serves as the ground truth for the bilirubin concentrations.
8. The sample size for the training set
- Not Applicable. This is a calibrator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
§ 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.