(595 days)
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Benzodiazepines I | Oxazepam | 200 ng/mL |
| Methamphetamine | S-(+)-Methamphetamine | 500 ng/mL |
| Noroxycodone | Noroxycodone | 100 ng/mL |
| Methadone | (±)-Methadone | 300 ng/mL |
The Evidence MultiSTAT DOA Urine MultiPlex 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) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilised antibodies specific to different Drugs of Abuse (DOA) compound classes, A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
The Evidence MultiSTAT System uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT Analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.
The provided text describes a 510(k) premarket notification for the Randox Laboratories Limited, Evidence MultiSTAT DOA Urine Multiplex, and Evidence MultiSTAT device. This device is an in-vitro diagnostic (IVD) for the qualitative determination of drugs of abuse in human urine.
Crucially, the document does NOT describe the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.
The document details the device's intended use, methodology (competitive immunoassay), analytes tested, and cut-off values. It mentions that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices" but does not provide any specific data, acceptance criteria values, or details of these studies.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML context, because the provided text is for an IVD immunoassay device, not an AI/ML-powered medical device.
To answer your request based on the provided text, I can only state what is missing from the document related to AI/ML acceptance criteria and studies:
- No AI/ML Component: The device described is an immunoassay system (Evidence MultiSTAT DOA Urine Multiplex and Evidence MultiSTAT analyzer), which works based on chemical reactions and light detection, not artificial intelligence or machine learning.
- No Acceptance Criteria or Performance Data Provided: The document states that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices," but it does not provide any of the acceptance criteria themselves, nor the results of these studies. Therefore, no table of acceptance criteria vs. reported performance can be generated from this text.
- No Test Set Details: Since no performance study details are given, there is no information on:
- Sample size for the test set.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- No Training Set Details: As this is not an AI/ML device, there is no mention of a training set or how ground truth for a training set would be established.
In summary, the provided FDA 510(k) clearance letter and summary pertain to a traditional in-vitro diagnostic immunoassay system and do not contain any information relevant to the acceptance criteria or performance studies of an AI/ML-powered medical device.
§ 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).