(71 days)
The SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.
The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.
The provided text describes a qualitative diagnostic reagent, the SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, not a medical "device" in the sense of a machine or AI system typically requiring extensive performance studies with complex acceptance criteria. Therefore, many of the requested categories for a medical device's performance study, especially those related to AI and human reader effectiveness, are not applicable to this submission.
Here's an analysis based on the provided text, focusing on what is relevant for this type of diagnostic reagent.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of qualitative diagnostic assay, "acceptance criteria" are typically related to its intended use and demonstrating substantial equivalence to a predicate device. The primary performance characteristic highlighted is stability.
| Acceptance Criteria (Implied/General for IVD Reagents) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | Supported by Premarket Notification data |
| Stability | 12 months (validated by stress stability studies) |
| Qualitative Determination of Opiates | Intended for use in qualitative determination at 2000 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance data or the data provenance (e.g., country of origin, retrospective/prospective). It generally states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution."
For in vitro diagnostic reagents, performance studies typically involve testing a range of known positive and negative samples, as well as samples with concentrations around the cutoff. However, the specific details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to this type of in vitro diagnostic reagent. The "ground truth" for chemical assays like this is established by reference methods, known concentrations of analytes, or other validated diagnostic tests, not by expert consensus on image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of in vitro diagnostic reagent. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This concept is not applicable. This is a laboratory reagent for chemical analysis, not an AI-powered diagnostic imaging or decision support system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. This is a chemical reagent, not an algorithm. The "performance" is the reagent's ability to react with opiates in a urine sample to produce a qualitative result (positive/negative) when analyzed by the SYNCHRON System. The system itself is "standalone" in its analytical process, but it's not an algorithm in the sense of AI.
7. The Type of Ground Truth Used
The "ground truth" for a chemical assay like this would typically be established by:
- Known concentrations: Using urine samples spiked with known amounts of opiates.
- Reference analytical methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS), which is considered a gold standard for drug identification and quantification.
- Comparison to a legally marketed predicate device: As this submission emphasizes, substantial equivalence to the Emit® II Opiates 300/2000 Assay is crucial. The predicate's performance would serve as a comparative ground truth.
The document states: "The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL". This implies that the ground truth is based on the concentration of opiates in urine relative to the 2000 ng/mL cutoff, determined by reliable analytical methods and calibrated using reference calibrators.
8. The Sample Size for the Training Set
This concept is not applicable as this is not an AI or machine learning device that requires a "training set." The development of the reagent involves chemical formulation and optimization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the reasons stated above.
§ 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).