(89 days)
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital reagent kits.
Here's a breakdown of the acceptance criteria and study details for the K071644 device, the ONLINE TDM Phenobarbital assay:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device appear to be implicit in its comparison to a predicate device (COBAS INTEGRA Phenobarbital) and the stated "acceptable results" from evaluation studies. The performance characteristics evaluated were precision, lower detection limit, method comparison, specificity, and interfering substances. The provided data focuses on precision and method comparison.
| Performance Metric | Acceptance Criteria (Implicit - Compared to Predicate) | Reported Device Performance (ONLINE TDM Phenobarbital) | Predicate Device Performance (COBAS INTEBAS Phenobarbital) |
|---|---|---|---|
| NCCLS Precision, Within run | |||
| Control 1 Mean (µg/ml) | (To be comparable to predicate) | 9.6 | 12.0 |
| Control 1 SD (µg/ml) | (To be comparable to predicate) | 0.13 | 0.25 |
| Control 1 CV% | (To be comparable to predicate) | 1.3 | 2.1 |
| Control 2 Mean (µg/ml) | (To be comparable to predicate) | 24.1 | 23.4 |
| Control 2 SD (µg/ml) | (To be comparable to predicate) | 0.18 | 0.51 |
| Control 2 CV% | (To be comparable to predicate) | 0.7 | 2.2 |
| Control 3 Mean (µg/ml) | (To be comparable to predicate) | 45.2 | 52.0 |
| Control 3 SD (µg/ml) | (To be comparable to predicate) | 0.37 | 1.52 |
| Control 3 CV% | (To be comparable to predicate) | 0.8 | 2.9 |
| NCCLS Precision, Total | |||
| Control 1 Mean (µg/ml) | (To be comparable to predicate) | 9.6 | 12.0 |
| Control 1 SD (µg/ml) | (To be comparable to predicate) | 0.34 | 0.26 |
| Control 1 CV% | (To be comparable to predicate) | 3.5 | 2.2 |
| Control 2 Mean (µg/ml) | (To be comparable to predicate) | 24.1 | 23.4 |
| Control 2 SD (µg/ml) | (To be comparable to predicate) | 0.59 | 0.62 |
| Control 2 CV% | (To be comparable to predicate) | 2.4 | 2.7 |
| Control 3 Mean (µg/ml) | (To be comparable to predicate) | 45.2 | 52.0 |
| Control 3 SD (µg/ml) | (To be comparable to predicate) | 0.82 | 2.04 |
| Control 3 CV% | (To be comparable to predicate) | 1.8 | 3.9 |
| Method Comparison (vs. Predicate) | (High correlation, slope near 1, intercept near 0) | y = 1.047x - 0.339, r = 0.996 | y = 1.036x - 1.236, r = 0.995 (vs. FPIA) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: Not explicitly stated as a "test set" in the context of individual patient samples, but control materials were used. The sample size would refer to the number of replicates for each control level for the NCCLS precision evaluations. This information is not provided.
- Method Comparison (ONLINE TDM Phenobarbital vs. COBAS FP Phenobarbital):
- Sample Size: N=53
- Data Provenance: Not specified, but generally for method comparisons in medical devices, these are laboratory samples, likely prospective. The origin (country/retrospective/prospective) is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This device is an in-vitro diagnostic (IVD) for quantitative measurement. The "ground truth" is typically the measurement performed by a reference method or predicate device. There is no mention of human experts establishing ground truth in this context, as it's a quantitative chemical assay.
4. Adjudication Method for the Test Set
- Not applicable. This is a quantitative chemical assay; results are compared directly, not adjudicated by experts for diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for medical imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. This device is a quantitative chemical analyzer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is an inherently "standalone" device in its primary function as a laboratory analyzer. It provides a numerical result without direct human interpretation in the measurement process itself. The performance described (precision, method comparison) reflects the standalone analytical capability of the device.
7. The Type of Ground Truth Used
- Precision: The "ground truth" for precision is the expected value of the control material, and the device's ability to consistently measure around that value.
- Method Comparison: The "ground truth" for the method comparison was the results obtained from the COBAS FP Phenobarbital (an existing and presumably validated method). The predicate device (COBAS Integra Phenobarbital) also performed a method comparison against FPIA.
8. The Sample Size for the Training Set
- Not applicable as this is a chemical assay, not a machine learning or AI-driven diagnostic device that typically employs a "training set." The assay's performance is based on its chemical reagents and instrument calibration, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above (not an AI/ML device with a training set).
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.