(150 days)
The CEDIA Buprenorphine II Assay is a homogeneous enzyme immunoassay for the qualitative and/or semiquantitative determination for the presence of buprenorphine and its metabolites in human urine at a cut-off concentration of 10 ng/ mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect buprenorphine and its metabolites in human urine. The assay is designed for use with a number of clinical chemistry analyzers.
The semi-quantitative 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/tandem mass spectrometry (LC-MS/ MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
CEDIA Buprenorphine II Calibrators:
The CEDIA Buprenorphine II calibrators and CEDIA Negative Calibrator II are intended for the calibration of the CEDIA Buprenorphine II Assay in human urine. For In Vitro Diagnostic Use Only.
CEDIA Buprenorphine II Control Set:
The CEDIA Buprenorphine II controls are used to validate the CEDIA Buprenorphine II Assay calibration in human urine. For In Vitro Diagnostic Use Only.
The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include mouse monoclonal anti-buprenorphine antibody, recombinant microbial "enzyme donor'' - buprenorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives. Calibrators and controls are sold separately.
Here's a breakdown of the acceptance criteria and study information for the CEDIA Buprenorphine II Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance (CEDIA Buprenorphine II Assay) |
|---|---|---|
| Precision (Qualitative Mode) | -100% to -25% spiked samples: 100% Negative | -100% to -25% spiked samples: 100% Negative (80/80) |
| +25% to +100% spiked samples: 100% Positive | +25% to +100% spiked samples: 100% Positive (80/80) | |
| At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoff | At 100% cutoff (10 ng/mL): 27 Negative / 53 Positive (80 determinations) | |
| Precision (Semi-Quantitative Mode) | -100% to -25% spiked samples: 100% Negative | -100% to -25% spiked samples: 100% Negative (80/80) |
| +25% to +100% spiked samples: 100% Positive | +25% to +100% spiked samples: 100% Positive (80/80) | |
| At 100% cutoff (10 ng/mL): Mix of Negative/Positive results expected around cutoff | At 100% cutoff (10 ng/mL): 35 Negative / 45 Positive (80 determinations) | |
| Spike Recovery (Semi-Quantitative) | Spiked 7.5 ng/mL sample: Negative | 100% (20/20) Negative |
| Spiked 12.5 ng/mL sample: Positive | 100% (20/20) Positive | |
| Recovery within 80-120% of nominal values | Achieved for spiked samples | |
| Analytical Recovery and Dilution Linearity | (Implicit: Acceptable linearity and recovery across range for accurate quantification) | Refer to table for specific levels; e.g., 5 ng/mL - 119.8%, 100 ng/mL - 104.7% |
| Method Comparison and Accuracy (Qualitative) | (Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones) | High agreement in "Negative" (50% cutoff) categories. Discordant samples detailed. |
| Method Comparison and Accuracy (Semi-Quantitative) | (Implicit: High agreement with LC-MS/MS, especially outside near-cutoff zones) | High agreement in "Negative" (50% cutoff) categories. Discordant samples detailed. |
| Specificity (Cross-reactivity with Buprenorphine metabolites) | (Implicit: Detect target analytes effectively) | Buprenorphine, Norbuprenorphine, Norbuprenorphine-ß-D-glucuronide: ≥ 100% cross-reactivity. Buprenorphine-ß-D-glucuronide: 76.9% cross-reactivity. |
| Specificity (Cross-reactivity with other compounds) | (Implicit: Negligible cross-reactivity with structurally related/unrelated opiates and other commonly co-administered drugs) | Negligible cross-reactivity ( |
§ 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).