(51 days)
The Randox Laboratories Limited Therapeutic Drug Calibrators are based on Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels.
The Randox Laboratories Limited Therapeutic Drug Calibrator should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Therapeutic Drug Calibrators are based on Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels.
This document is a 510(k) clearance letter from the FDA for a medical device called "Therapeutic Drug Calibrator." It primarily addresses the regulatory approval process and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a performance study report.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it does not include the detailed performance data or study design elements you specified.
Here's why I cannot fulfill your request based on the provided text:
- Acceptance Criteria & Reported Performance: The document doesn't define specific numerical acceptance criteria (e.g., accuracy percentages, precision metrics) or provide reported device performance data against such criteria.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication): There is no mention of the sample sizes used, whether the data was retrospective or prospective, the country of origin, the number or qualifications of experts, or any adjudication methods.
- MRMC Study: The document does not describe a multi-reader multi-case comparative effectiveness study.
- Standalone Performance: While the device is a calibrator and would have inherent standalone performance characteristics, the document does not present them.
- Ground Truth: The document does not specify the type of ground truth used (e.g., pathology, expert consensus) or how it was established for either test or training sets.
- Training Set Sample Size: No information about a training set or its sample size is provided.
This document is a regulatory approval notice, not a scientific study report. For the information you're seeking, a separate study report or regulatory submission detailing the device's validation and performance would be required.
§ 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.