(68 days)
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml.
Principal of procedure: The COBAS INTEGRA ONLINE DAT II Methadone II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drugpolymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
This document is a 510(k) summary for the Roche Diagnostics COBAS INTEGRA ONLINE DAT II Methadone II, an in vitro diagnostic reagent system for the detection of methadone in human urine. It establishes substantial equivalence by comparing it to a previously cleared predicate device, the Roche COBAS INTEGRA Methadone assay (K951595). The summary describes the device's intended use and the principle of its operation (Kinetic Interaction of Microparticles in Solution - KIMS).
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include explicit acceptance criteria in terms of numerical thresholds (e.g., sensitivity, specificity, accuracy percentages) or a table of reported device performance against such criteria. The document focuses on establishing substantial equivalence to a predicate device and describes the assay's principle.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for any performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. For an in vitro diagnostic device like this, ground truth would typically be established through confirmatory analytical methods, not expert human interpretation.
4. Adjudication Method
The provided text does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices involving human interpretation of results (e.g., radiology images). This device is an automated in vitro diagnostic assay for detecting methadone in urine. Therefore, an MRMC comparative effectiveness study would not be applicable or performed for this type of device. There is no mention of such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is an in vitro diagnostic assay, meaning it operates in a standalone manner to produce a result. The entire description of its operation (KIMS principle) is a description of its standalone performance. However, the document does not present a dedicated "standalone performance study" section with specific metrics, but rather implicitly asserts its standalone capability through the description of its mechanism and intended use. The focus is on its performance in comparison to a predicate device for substantial equivalence.
7. Type of Ground Truth Used
For a methadone detection assay, the ground truth would typically be established by confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS). The provided text does not explicitly state how the ground truth was established, but given the nature of the device, it would be laboratory-based analytical confirmation.
8. Sample Size for the Training Set
The provided text does not specify the sample size for a training set. This type of in vitro diagnostic assay might be developed and optimized through iterative testing and calibration, but the concept of a "training set" as understood in machine learning (which often requires explicit specification) is not typically detailed in 510(k) summaries for such devices.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, the provided text does not describe how ground truth for a training set was established.
Summary of what is available in the provided text:
- Acceptance Criteria & Performance: Not explicitly stated or tabulated.
- Test Set Sample Size & Provenance: Not provided.
- Expert Ground Truth & Qualifications: Not applicable/not provided.
- Adjudication Method: Not applicable/not provided.
- MRMC Study: Not applicable/not performed.
- Standalone Performance: Implicitly described by the device's operational principle, but no separate study details are provided.
- Type of Ground Truth: Implied to be confirmatory analytical methods, but not explicitly stated.
- Training Set Sample Size: Not provided.
- Training Set Ground Truth Establishment: Not provided.
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Roche COBAS INTEGRA Methadone assay, K951595) by detailing the device's description, intended use, and principal of procedure, and highlighting modifications from the predicate. It does not provide detailed performance study data against specific acceptance criteria.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).