(418 days)
The Emit® II Plus Buprenorphine Assay is a homogeneous enzyme immunoassay with a 5 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of buprenorphine in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures.
The Emit® II Plus Burrenorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/ MS) or LC/MS are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
For Professional Use.
Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare professional.
For in vitro diagnostic use.
The Emit® II Plus Buprenorphine Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with the recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
The Emit® II Plus Buprenorphine Assay reagents are provided liquid, ready to use and may be used directly from the refrigerator. The product is sold in three (3) kit sizes: 28 mL, 115 mL, and 1000 mL. Reagents 1 and 2 are provided as a matched set. They should not be interchanged with components of kits with different lot numbers.
Antibody/Substrate Reagent 1: Mouse monoclonal antibodies to buprenorphine (0.53 µg/mL)*.NAD (6.9 mM), G6P (10.9 mM), bovine serum albumin, preservatives, and stabilizers. *The antibody titer and enzyme conjugate activity may vary from lot to lot.
Enzyme Reagent 2: Norbuprenorphine labeled with bacterial rG6PDH (0.50 µg/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers, where the antibody titer and enzyme conjugate activity may vary from lot to lot.
The marketing submission for the Siemens Healthineers Emit® II Plus Buprenorphine Assay (K221605) demonstrates that the device meets its acceptance criteria through various performance studies. Below is a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as strict numerical thresholds in the provided document, but rather demonstrated through the qualitative agreement and recovery percentages, as well as precision and specificity profiles. Based on the "Method Comparison" results, the implicit acceptance criterion for qualitative agreement against LC/MS/MS is a high percentage, and for recovery, it's generally close to 100%. For specificity, it's low or negligible cross-reactivity with other substances (ideally less than the cutoff concentration when tested at high concentrations). For precision, it's low coefficient of variation (CV).
| Metric / Acceptance Criteria | Reported Device Performance (Emit® II Plus Buprenphine Assay on DxC 500 AU) |
|---|---|
| Method Comparison (Qualitative Agreement with LC/MS/MS) | 92.5% Agreement |
| Recovery vs Nominal Value | Ranges from 95% to 104% (average ~98.5%) |
| Recovery vs LC/MS/MS | Ranges from 86% to 100% (average ~93.8%) |
| Precision (Repeatability %CV) | 1.1% to 6.6% (for relevant concentration ranges) |
| Precision (Within-Lab Precision %CV) | 2.8% to 6.6% (for relevant concentration ranges) |
| Total Reproducibility Precision %CV | 3.0% to 5.3% |
| Specificity (Cross-reactivity with Buprenorphine Metabolites) | Buprenorphine: 98%, Norbuprenorphine: 106%, Glucuronides: 0.10% |
| Specificity (Cross-reactivity with Structurally Related Compounds) |
§ 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).