(248 days)
Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative mode is for purposes of (1) Enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS, or (2) Permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograph/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.
Randox Multidrug Controls, Level 1 & 2: The Randox Multidrug Controls, level 1 and 2 are for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.
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Here's a breakdown of the acceptance criteria and study information based on the provided text, filled in as much as possible given the limitations of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes an FDA 510(k) clearance for the Randox Opiates Assay, Randox Multidrug Calibrator Set, and Randox Multidrug Controls. The core of this clearance hinges on "substantial equivalence" to legally marketed predicate devices. The document explicitly states the "cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated." While it doesn't provide a detailed table of "acceptance criteria" in the format one might see for a diagnostic device's sensitivity/specificity, this cutoff is a key performance parameter and an implied acceptance criterion for the assay's function.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Qualitative/Semi-quantitative Opiates assay cut-off (for morphine) | 2000 ng/mL |
| Calibration for Amphetamine, Barbiturates, Methadone, and Opiate assays using Multidrug Calibrator Set on RX series analyzers | Developed for use on RX series analyzers (RX Daytona and RX Imola) |
| Quality control for Amphetamine, Barbiturates, Methadone, and Opiate assays using Multidrug Controls on RX series analyzers | Developed for use on RX series analyzers (RX Daytona and RX Imola) |
| Intended for prescription use only | Device is intended for prescription use only |
| Provides preliminary analytical test result, requiring confirmatory method for confirmed analytical result | Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result (e.g., GC/MS). |
| Semi-quantitative mode for specific purposes (dilution, QC) | Purposes explicitly stated: (1) Enabling laboratories to determine an appropriate dilution for confirmation (e.g., GC/MS), or (2) Permitting laboratories to establish quality control procedures. |
Study Information:
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This implies that the manufacturer submitted data demonstrating equivalence in performance characteristics to existing, cleared assays.
Since this is a clearance letter, specific details about the studies themselves are not present. However, we can infer some information from the nature of the device:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. As the manufacturer is based in the United Kingdom, it's possible some or all of the data originated there, but this is not confirmed. The clinical context (human urine samples, diagnosis and treatment of Opiate use/overdose) suggests that the data would be from human subjects. The fact that GC/MS is mentioned as a confirmatory method indicates a rigorous approach to ground truth establishment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not available in the provided document. For drug testing, the "ground truth" is typically established by a gold standard confirmatory method like Gas Chromatography-Mass Spectrometry (GC/MS), rather than human expert consensus on initial assay results.
4. Adjudication Method for the Test Set
- This information is not available in the provided document. Given that GC/MS is the preferred confirmatory method, the "adjudication" would be based on the objective results of that method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically for evaluating observer performance with imaging or subjective diagnostic tasks. This device is an in-vitro diagnostic test for chemical analysis (opiates in urine), which is an objective measurement. Therefore, an MRMC study would not be applicable or performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The Randox Opiates Assay is an in-vitro diagnostic device run on automated analyzers (RX Daytona, RX Imola). Its performance characteristics (like sensitivity, specificity, cutoff) would be evaluated in a standalone manner, i.e., the instrument and reagent system's ability to correctly identify and quantify opiates in urine samples without direct human interpretation of the assay result itself. Human involvement comes in collecting the sample, running the test, and interpreting the clinical significance of the result, especially requiring confirmation for positive preliminary results.
7. The Type of Ground Truth Used
- Confirmatory Analytical Method, specifically Gas Chromatograph/Mass Spectrometry (GC/MS). The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograph/Mass Spectrometry (GC/MS) is the preferred confirmatory method."
8. The Sample Size for the Training Set
- This information is not available in the provided document. For an IVD assay, the "training set" would refer to the samples used during product development and optimization to establish assay parameters like the 2000 ng/mL cutoff, linearity, precision, etc. The specific number of samples used for this development is not disclosed in the FDA clearance letter.
9. How the Ground Truth for the Training Set Was Established
- This information is not available in the provided document. However, given the nature of the device, the ground truth for optimizing the assay would have been established using precisely prepared samples with known concentrations of opiates (spiked controls) and/or clinically relevant samples (patient urine) that have been thoroughly characterized by a gold-standard method like GC/MS.
§ 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).