(63 days)
Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This 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.
Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This 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 measurement of substances in human specimens.
The provided text describes a 510(k) submission for "Abuscreen ONLINE® BENZ 300 Calibrators". However, the document explicitly states: "No clinical or nonclinical tests were necessary to establish substantial equivalence."
Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission establishes equivalence to a predicate device ("Abuscreen ONLINE Calibration Pack," K951595) based on technological characteristics rather than performance data from a new study.
Here's a breakdown of why I cannot fulfill your request for performance data and study details:
- Acceptance Criteria and Reported Device Performance: No acceptance criteria or reported device performance for the new device are mentioned in the text. The only performance-related information provided is a comparison of benzodiazepine levels (ng/mL) for calibration, which are simply the concentrations offered by the calibrators, not performance metrics.
- Sample Size for Test Set and Data Provenance: Not applicable as no new test set or study was conducted.
- Number of Experts and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance: Not applicable.
- Type of Ground Truth: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
The submission focuses solely on establishing substantial equivalence to a previously cleared device by comparing characteristics like matrix, intended use, and the levels of benzodiazepines in the calibrators.
Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Not explicitly stated as performance criteria but as characteristics for equivalence) | Reported Device Performance (Characteristics of the new device) |
|---|---|---|
| Matrix | Must be urine (implied by predicate) | urine |
| Intended Use | For calibration of Roche assays for benzodiazepines (implied by predicate functionality for benzodiazepines) | for the calibration of Roche assays for benzodiazepines |
| Levels of Benzodiazepines (ng/mL) | Specific levels (0, 50, 100, 200) for calibration (from predicate) | 0, 150, 300, 600 |
Explanation of Study (or lack thereof):
The document explicitly states in Section VI: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence: No clinical or nonclinical tests were necessary to establish substantial equivalence."
This means that a new study as you describe (with test sets, ground truth, expert review, etc.) was not performed for this 510(k) submission. Substantial equivalence was determined based on a comparison of the new device's characteristics (matrix, intended use, and calibration levels) with those of an already legally marketed predicate device (Abuscreen ONLINE Calibration Pack, K951595). The changes in the benzodiazepine levels (0, 150, 300, 600 ng/mL for the new device versus 0, 50, 100, 200 ng/mL for the predicate) are presented as a characteristic difference, not as a result of performance testing in this specific 510(k).
§ 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.