(88 days)
The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of oxycodone and its metabolite in human urine. The LZI Oxycodone Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/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 used.
LZI's Oxycodone Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect oxycodone and oxymophone in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between oxycodone derivative labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme and free drug from sample for a fixed amount of specific antibody. In the absence of free drug from the sample, the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 mm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
The provided document describes the LZI Oxycodone Enzyme Immunoassay, but it does not contain information regarding acceptance criteria and the study that proves the device meets those criteria, as typically found in comprehensive clinical validation studies for AI/ML devices.
This document is a 510(k) summary for an in vitro diagnostic device (an enzyme immunoassay for drug detection), and as such, the performance evaluation focuses on analytical characteristics and comparison to a predicate device, rather than the kind of comprehensive clinical validation study with human readers, ground truth consensus, and multi-reader multi-case (MRMC) analysis typically associated with AI/ML-based medical devices.
Therefore, I cannot populate the requested information from the provided text. The document focuses on:
- Comparison to a predicate device (DRI® Oxycodone Assay K040411): Highlighting similarities in intended use, method principle, and analytical characteristics.
- Analytical performance: Implicitly tested through cross-reactivity studies, precision, and linearity, but no specific "study" with acceptance criteria in the format you requested for AI/ML evaluation.
- Intended Use: Defining how the assay should be used.
There is no mention of:
- A table of acceptance criteria and reported device performance (in the context of an AI/ML device validating against specific clinical metrics).
- Sample size for a test set or data provenance for a clinical test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- MRMC studies or effect sizes of AI assistance.
- Standalone performance (as it's a diagnostic test, not an AI algorithm assisting human interpretation).
- The type of ground truth used (beyond implying chemical confirmation methods like GC/MS).
- Sample size for a training set (as it's a chemical assay, not a trained AI model).
- How ground truth for a training set was established.
The "studies" conducted for this type of device typically involve analytical validation (e.g., specificity, sensitivity, precision, accuracy against known concentrations, cross-reactivity to other substances, linearity) rather than a clinical study evaluating diagnostic accuracy through expert consensus and MRMC design.
If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.
§ 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).