(35 days)
The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 nq/mL, on SYNCHRON Systems.
The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.
The provided text describes a 510(k) submission for the Beckman SYNCHRON Systems Methadone (METD) Reagent. This submission aims to demonstrate substantial equivalence to a predicate device, focusing on a new formulation of the reagent.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the submission relies on demonstrating "substantial equivalence" to a predicate device, particularly regarding "safety and effectiveness."
The primary performance aspect discussed is the specificity of the monoclonal antibody.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Specificity of new monoclonal antibody formulation | Specific only to methadone |
| Stability | 12 months at 4°C and 60 days on a SYNCHRON instrument |
| Equivalence to Predicate Device | Same intended use, chemical reaction, calibration, reagent kit configuration, product part number. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "data in the Premarket Notification" that supports substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for any test set, nor does it refer to their number or qualifications.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance. This device is a diagnostic reagent, an in-vitro diagnostic (IVD), not an AI-powered diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance Study
As this is a diagnostic reagent (IVD) and not an AI algorithm, the concept of "standalone (algorithm only)" performance does not directly apply in the typical sense of AI-based diagnostics. The performance described relates to the reagent's analytical characteristics. The provided text does not detail specific standalone performance studies in terms of diagnostic accuracy metrics. It only states that the new formulation is "specific only to methadone."
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of a methadone test system, the "ground truth" would typically be established by highly accurate confirmatory methods like GC/MS (which is mentioned as the preferred confirmatory method for positive results). However, the document doesn't explicitly state that these methods were used to establish the ground truth for the performance data submitted.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is a characteristic typically associated with machine learning or AI models, which is not applicable to this diagnostic reagent submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as this is not an AI/ML device), there is no information on how ground truth for a training set was established.
§ 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).