(95 days)
The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use.
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Immunoassay for the qualitative detection of Oxycodone in urine. The QuickScreen™ Oxycodone Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.
The provided text describes the 510(k) summary for the QuickScreen™ Oxycodone Test. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format (e.g., Sensitivity > X%, Specificity > Y%). However, it makes a general claim of substantial equivalence.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices | >99% correlation when compared to predicate devices in laboratory studies using clinical specimens. |
| Qualitative immunoassay for detection of oxycodone in urine at a cutoff concentration of 100 ng/ml. |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: Not explicitly stated as a number of samples. It mentions "clinical sample correlation study" and "laboratory studies, using clinical specimens."
- Data Provenance: "clinical sample correlation study" and "laboratory studies, using clinical specimens." No specific country of origin is mentioned, but the manufacturer is based in San Diego, California, USA, suggesting a US context. The study is retrospective given "clinical specimens" would imply pre-existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The study compares the QuickScreen™ Oxycodone Test to "predicate devices," implying the predicate device's results were used as a reference, but no information on how the predicate device's results themselves were adjudicated is given.
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
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for drug detection, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a rapid, qualitative immunoassay designed for "professional use," which implies a human in the loop for interpretation of the visual color change. However, the performance reported (" >99% correlation") likely refers to the intrinsic performance of the test strip itself against a reference method or predicate, acting as a standalone evaluation of the device's accuracy in detecting the analyte. It's an "algorithm only" in the sense that the test strip is a chemical algorithm.
7. The Type of Ground Truth Used
The ground truth for the "clinical sample correlation study" and "laboratory studies, using clinical specimens" appears to be the results obtained from predicate devices (e.g., ABMC RapidOne Oxycodone test) and likely a confirmatory analytical method mentioned later as the "preferred confirmatory method" once a preliminary positive result is obtained (Gas chromatography/mass spectrometry (GC/MS)). The statement "A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method" suggests that these methods serve as the ultimate ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires separate training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is not applicable and hence, not provided.
§ 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).