(260 days)
For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems. Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator.
For in vitro diagnostic use in the calibration of assays for the detection of Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin in human serum and plasma for use on clinical laboratory analyzers. Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.
Each TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set is packaged in a rectangular cardboard box with a 12-bottle divider, a product insert, and a value sheet. Kits are stored refrigerated at 2-8°C. Each kit contains 6 levels of calibrators with the following configurations. The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are prepared from a bovine serum matrix and contains the following analytes: amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, theophylline, valproic acid, and vancomycin. Sodium azide at 0.09% and ProClin 300 at 0.1% are present as preservatives. TDM Multiconstituent Calibrator and QMS® TDM Multi-Constituent Calibrator levels are provided in liquid ready to use form and to be stored at 2-8°C until the expiration date on the label. Once opened, the opened bottles are stable for 60 days when capped tightly and stored at 2-8°C.
The provided 510(k) summary describes a calibrator device for in vitro diagnostic use, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Summary of Testing" table.
Acceptance Criteria and Reported Device Performance
| Evaluation Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Target Achievement | L1: Negative | |
| L2: Difference within +/- 0.3 µg/mL (Amikacin), +/- 0.5 µg/mL (Carbamazepine), +/- 0.1 ng/mL (Digoxin), +/- 0.1 µg/mL (Gentamicin), +/- 1.0 µg/mL (Phenobarbital), +/- 0.6 µg/mL (Phenytoin), +/- 0.2 µg/mL (Quinidine), +/- 0.6 µg/mL (Theophylline), +/- 3.0 µg/mL (Valproic Acid), +/- 0.5 µg/mL (Vancomycin) | ||
| L3: Difference within +/- 15% (Digoxin), +/- 10% (all other analytes) | ||
| L4 to L6: Difference within +/- 10% (All analytes) | Pass | |
| Antimicrobial Effectiveness Test (USP Category 4) | Pass challenge against: P. aeruginosa, E. coli, S. aureus, C. albicans, A. niger | Pass |
| Open Bottle Stability | L1: Negative | |
| L2 to L6: Value change within +/- 10% | Pass | |
| Accelerated Stress Stability to Predict Shelf Life | L1: Negative | |
| L2 to L6: Value change within +/- 10% | Predicted (24 months @2-8°C) | |
| Real-Time Stability | L1: Negative | |
| L2: Value change within +/- 15% | ||
| L3 to L6: Value change within +/- 10% | In process |
Non-Applicable / Not Provided Information for AI/ML Device Study:
The following information is either not applicable to this type of medical device (a calibrator for IVD assays) or is not provided in the summary document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator. The testing involves laboratory measurements of the calibrator's performance against defined targets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for a calibrator would refer to the true concentrations of the analytes, which are established during its manufacturing and characterization rather than by expert review of patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an IVD calibrator, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" implicitly refers to the accurately assigned target concentrations of the analytes within the calibrator solutions. These are determined through precise chemical analysis and manufacturing processes, not clinical expert consensus or pathology.
- The sample size for the training set: Not applicable. There is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.