(34 days)
The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Buprenorphine Urine Controls:
The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay.
Immunalysis Buprenorphine Urine Calibrators:
The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes rabbit antibodies to Buprenorphine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes buprenorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The buprenorphine calibrator and controls consists of a single calibrator at 5ng/mL, a control set containing a LOW control at 3.75ng/mL and a HIGH control at 6.25ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 5ng/mL, a Level 2 calibrator at 10ng/mL, a Level 3 calibrator at 20ng/mL and a Level 4 calibrator at 40ng/mL.
Here's a breakdown of the acceptance criteria and study details for the Immunalysis Buprenorphine Urine Enzyme Immunoassay, based on the provided 510(k) summary:
This device is an in-vitro diagnostic (IVD) test, not an AI/ML-based device that interprets images or signals using algorithms learned from data. Therefore, many standard AI/ML evaluation criteria, such as MRMC studies, expert adjudication, or separate training/test sets with human-in-the-loop performance, are not applicable here. The "acceptance criteria" for this device are defined by its analytical performance metrics, which show it functions as intended for its intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets in the same clear format as for an AI/ML device (e.g., "sensitivity > 90%"). Instead, the acceptability is demonstrated by the device meeting certain performance characteristics (precision, specificity, linearity, non-interference) that are deemed adequate for its intended use as a qualitative and semi-quantitative drug test. The FDA's substantial equivalence determination implies these criteria were met.
The performance studies and their results serve as the "reported device performance" and, by implication, demonstrate meeting the acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Precision/Cutoff Characterization: Consistent and accurate determination of positive/negative results around the 5 ng/mL cutoff, and reproducibility of measurements. | Qualitative: 100% agreement for concentrations ≤ 3.75 ng/mL (Negative) and ≥ 6.25 ng/mL (Positive). At the 5 ng/mL cutoff, 48/80 (60%) were Negative and 32/80 (40%) were Positive. This demonstrates the cutoff serves as a boundary. Semi-Quantitative: 100% agreement for concentrations ≤ 3.75 ng/mL (Negative) and ≥ 6.25 ng/mL (Positive). At the 5 ng/mL cutoff, 33/80 (41.25%) were Negative and 47/80 (58.75%) were Positive. Precision was evaluated over 20 days, 2 runs/day in duplicate (N=80). |
| Specificity and Cross-Reactivity: Minimal interference from structurally similar compounds and no interference from other common drugs or compounds. | Structurally Related Compounds: Buprenorphine (100% cross-reactivity), NorBuprenorphine (90.91%), Buprenorphine Glucuronide (0.17%), NorBuprenorphine Glucuronide (0.13%). All other listed opioids and common drugs (e.g., 6-Acetyl morphine, Codeine, Heroin, Morphine, Methadone, Oxycodone, etc.) showed "N.D." (Not Detected/ |
§ 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).