(179 days)
The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use.
| Analyte | Calibrator | Cutoff |
|---|---|---|
| Morphine/Opiates | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Oxycodone | Oxycodone | 300 ng/mL |
This assay provides only preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to three (3) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a colored band during test regardless of the presence of the drug.
Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on the established performance characteristics of the predicate devices. The reported device performance is stated to be the same as the individual tests, which were previously 510(k) cleared. While specific numerical performance metrics are not given for the proposed device, the summary implies it meets the performance standards of its predicates.
| Analyte | Cutoff (ng/ml) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Morphine | 300 | Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity) | Same as individual test devices. |
| Oxycodone | 100 | Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity) | Same as individual test devices. |
| Oxycodone | 300 | Same as predicate device performance (satisfactory accuracy, reproducibility, sensitivity, and specificity) | Same as individual test devices. |
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 of the proposed device. Instead, it makes a general statement that the "Performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of the multi-drug of abuse test are the same as the individual tests, which have been 510(k) cleared for professional use previously."
The data provenance (country of origin, retrospective/prospective) for the test set is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study relies on comparison to predicate devices, but details about how the performance was established for either the predicate or proposed device's test set ground truth are absent.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described for this device. This is an immunoassay, not an imaging device typically requiring such studies. The focus is on the device's analytical performance rather than human interpretation of complex images.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was implicitly done for the device. The 510(k) summary focuses entirely on the device's analytical performance, not on how humans interpret its results. It describes the device's technology and states that its performance characteristics (accuracy, reproducibility, sensitivity, and specificity) are the same as the individual tests. This implies direct measurement of the device's output against a known standard.
7. Type of Ground Truth Used
The document implies that the ground truth for establishing the performance of the individual tests (and by extension, the proposed multi-drug device) would involve chemical confirmation using methods like Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). The "Intended Use" section explicitly states: "A positive result from the device is considered to be a presumptive result and should never be interpreted as final without laboratory confirmation... Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method."
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It refers to the device using "the same technology and formulations for the detection of the drugs as individual test devices." This suggests that the "training" may have effectively been done on prior individual tests.
9. How the Ground Truth for the Training Set Was Established
Similar to the test set, the ground truth for the training set (or the development of the underlying technology for the individual tests) would have been established through chemical confirmation methods, likely GC/MS or LC/MS, to accurately determine the presence and concentration of the target analytes. The document states the proposed device uses "the same technology and formulations" as previously cleared individual tests, implying the ground truth methods were consistent with those used for predicate devices.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).