(46 days)
The Emit Calibrator/Controls are used in the callbration of the Emit II Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit II Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays.
The device is the Emit Calibrators' Controls , Lavels 0-5. The common or usual name is calibrators and/ or controls. The classification name is Clinical Toxicology Calibrator, 91 DKB. The Emit Calibrators/Controls contain various combinations of the following drugs at varying concentrations: benzoyecgonine, lormetazepam, methamphetamine, methaqualone, morphine, 11-delta 9-THC-9-COOH, phencyclidine, propoxyphene and secobarbital. They are intended to be used with the following respective Emit II Plus assays for detecting: eocaine metabolite, benzodiazepines, methadone, amphetamines, methaqualone, opiates, cannabinoids, phencyclidine, propoxyphene and barbiturates. The Emit Calibrators Controls are provided as ready-to-use liquids in a human urine matrix and they have characteristics common to a variety of commercially available calibrators and/or controls intended for use with assays for detecting drugs of-abuse. The do not have any expecially unique technical characteristics. Where applicable, calibrators include concentrations of analytes that are required by the US Substance Abuse and Mental Health Services Administration (SAMHSA) for detecting drugs-ofabuse. Nominal concentrations of each analyte are traceable to confirmation by GC/MS.
The provided text is a 510(k) summary for the Dade Behring Emit Calibrators/Controls. This document focuses on the substantial equivalence of the device to previously marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance.
Therefore, the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not present in the provided text.
The document states: "Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses." This is a general statement about studies, but no specific data, acceptance criteria, or methodology are provided.
However, based on the information that is available, here's what can be extracted:
Acceptance Criteria and Study Details for Emit Calibrators/Controls
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance acceptance criteria are mentioned for the calibrators/controls themselves, beyond being "sufficiently stable for their intended uses" and showing "no cross-reactivity or interference." | "Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While it's a US-based submission, the location of the studies is not detailed.
3. 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)
- Number of Experts: Not applicable/Not specified. The ground truth for the calibrators is based on chemical confirmation.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified.
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
- MRMC Study: No. This device is a calibrator/control, not an AI diagnostic system; therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a calibrator/control for assays, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The nominal concentrations of each analyte in the calibrators are established through confirmation by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate analytical chemistry technique used to identify and quantify substances within a sample, providing a definitive ground truth for the analyte concentrations.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. As a calibrator/control, the concept of a "training set" for an algorithm is not relevant.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. (See #8).
§ 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.