(36 days)
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use.
The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method.
The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva.
The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.
LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device.
The provided text describes the LabOne Cocaine Metabolite Micro-Plate EIA and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a table format with performance metrics as requested, nor does it detail a study proving the device meets specific acceptance criteria in the comprehensive manner implied by the prompt.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (STC Cocaine Metabolite Micro-Plate EIA) through performance characteristic studies.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with corresponding performance. Instead, it states that various performance characteristic studies showed the LabOne device to be substantially equivalent to the predicate device. The key comparison involved using GC/MS/MS as a reference.
| Characteristic | Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|---|
| Precision | Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA. | "Performance characteristic studies on precision... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA." |
| Analytical Sensitivity | Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA. | "Performance characteristic studies on ... analytical sensitivity... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA." |
| Interference | Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA. | "Performance characteristic studies on ... interference... showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA." |
| Antibody/Cross-reactivity | Performance comparable to the STC Cocaine Metabolite Micro-Plate EIA. | "Performance characteristic studies on ... antibody/cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA." |
| Overall Agreement with GC/MS/MS | Results from both the LabOne and STC systems should be substantially equivalent to GC/MS/MS results. | "Results... also showed that the [agreement] with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "patent speciale" (likely a typo for patient samples) and "diluted samples," but no numbers or details on their origin are provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This device is an in vitro diagnostic (EIA), not typically subject to MRMC studies like imaging devices that involve human interpretation.
6. Standalone Performance Study
Yes, a standalone performance assessment was done in the sense that the LabOne device's "performance characteristic studies" were conducted. The comparison was primarily against a predicate device and then against GC/MS/MS as a reference. The document states:
- "Performance characteristic studies on precision, analytical sensitivity, interference and antibody / cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA."
- "Results [from patient samples and diluted samples] also showed that the [agreement] with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference."
This implies a direct evaluation of the device's characteristics, with GC/MS/MS serving as the "gold standard" ground truth for assessing accuracy in a subset of the tests.
7. Type of Ground Truth Used
The primary ground truth used for assessing accuracy was Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS). The document explicitly states: "GC/MS/MS results as reference." It also mentions "patent speciale" (patient samples) and "diluted samples" being tested with both systems.
8. Sample Size for the Training Set
The document does not provide any information about a training set since this is a diagnostic assay, and the "study" described is for validation, not AI/machine learning model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/ML model is described.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).