(227 days)
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 analyses of buprenorphine in human urine. Emit® II Plus assays are designed for use with a number of 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 LC/MS or Permitting laboratories to establish quality control procedures.
The Emit® II Plus Buprenorphine 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.
Emit® II Plus Specialty Drug Calibrator/Control Level 1, Emit® II Plus Specialty Drug Calibrator/Control Level 2, Emit® II Plus Specialty Drug Calibrator/Control Level 3, Emit® II Plus Specialty Drug Calibrator/Control Level 4
The Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
Emit® II Plus Specialty Drug Control Negative and Emit® II Plus Specialty Drug Control Positive
The Emit® II Plus Specialty Drug Control Negative and Control Positive are for use with the Emit® II Plus Buprenorphine Assay.
The Emit® II Plus Buprenorphine assay is a homogeneous enzyme immunoassay with a 5 ng/mL cutoff. The assay, used for the detection of Buprenorphine in human urine, utilizes a two-reagent system. The Antibody/Substrate Reagent 1 is a liquid ready-to-use product comprised of mouse monoclonal antibodies to buprenorphine, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a liguid. ready-to-use product containing norbuprenorphine labeled bacterial recombinant glucose-6 phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers and is available in three sizes: large kit (1L), small kit (115 mL), and 28 mL Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Buprenorphine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.
Emit® II Plus Specialty Drug Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus Buprenorphine assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff. The matrix is pooled, drug-free, human urine based product containing buprenorphine, preservatives and surfactants. Each level of calibrator is packaged and sold separately, 1 plastic bottle per box, 10 mL in a 15 mL bottle. Values are nominal and are verified with urine based buprenorphine anchor pool and adjusted if needed. The anchor pool levels are verified by LC/MS/MS and are within 10% of nominal drug concentration for levels 2.5 and 5.0 ng/mL and within 5 % of nominal concentrations for levels 15 and 25 ng/mL.
Emit® II Plus Specialty Drug Control Negative and Emit® II Plus Specialty Drug Control Positive are in-vitro diagnostic products are for use with the Emit® II Plus Buprenorphine assay. The matrix is pooled, drug-free, human urine based product containing buprenorphine, preservatives and surfactants. The Control Negative and Control Positive are packaged separately in 15 mL plastic vials with a 10 mL fill per vial. Values are nominal and are verified with urine based buprenorphine anchor pool and adjusted if needed. Anchor pool levels are verified by LC/MS/MS.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Emit® II Plus Buprenorphine Assay, Emit® II Plus Specialty Drug Calibrator/Control Level 1-4, Emit® II Plus Specialty Drug Control Negative/Positive.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numbered or bulleted points in the provided document. However, based on the performance data presented, we can infer the criteria that the device aimed to meet for substantial equivalence. The document primarily focuses on demonstrating performance against expected standards for an in vitro diagnostic device for drug screening, particularly a qualitative and semi-quantitative assay.
Here's a table summarizing the inferred acceptance criteria and the device's performance:
| Acceptance Criteria Category/Inferred Criteria | Reported Device Performance |
|---|---|
| Precision (Qualitative Analysis) - Agreement near cutoff |
- Consistent classification (Negative/Positive) for concentrations significantly below/above cutoff.
- Acceptable level of concordant/discordant results near the cutoff for both qualitative and semi-quantitative modes. | Precision: Qualitative Analysis (5 ng/mL cutoff)
- 0, 2.5, 3, 3.75 ng/mL (below cutoff): 80 Negative out of 80 results (100% agreement).
- 5 ng/mL (cutoff): 25 Negative / 55 Positive (68.75% positive, 31.25% negative). This indicates some variability at the exact cutoff, which is typical for immunoassays.
- 6.25, 7, 7.5, 10 ng/mL (above cutoff): 80 Positive out of 80 results (100% agreement).
- Additional Precision Study:
- 1.25 ng/mL (-75% cutoff): 80 Negative out of 80 results (100% agreement).
- 8.75 ng/mL (+75% cutoff): 80 Positive out of 80 results (100% agreement).
Overall, good precision away from the cutoff, expected variability at the cutoff. |
| Precision (Semi-quantitative Analysis) - Agreement near cutoff
- Consistent classification (Negative/Positive) and semi-quantitative results for concentrations significantly below/above cutoff. | Precision: Semi-quantitative Analysis (5 ng/mL cutoff)
- 0, 2.5, 3, 3.75 ng/mL (below cutoff): 80 Negative out of 80 results (100% agreement).
- 5 ng/mL (cutoff): 25 Negative / 55 Positive (68.75% positive, 31.25% negative).
- 6.25, 7, 7.5, 10 ng/mL (above cutoff): 80 Positive out of 80 results (100% agreement).
- Additional Precision Study:
- 1.25 ng/mL (-75% cutoff): 80 Negative out of 80 results (100% agreement).
- 8.75 ng/mL (+75% cutoff): 80 Positive out of 80 results (100% agreement).
Results mirror qualitative analysis, demonstrating consistent semi-quantitative performance. |
| Specificity and Cross-reactivity - Buprenorphine Metabolites
- Appropriate cross-reactivity with buprenorphine and its primary active metabolite (norbuprenorphine).
- Low to no cross-reactivity with inactive glucuronide metabolites. | Buprenorphine Metabolite Recovery
- Buprenorphine (5 ng/mL): 103.2% recovery (5.2 ng/mL).
- Norbuprenorphine (5 ng/mL): 92.6% recovery (4.6 ng/mL).
- Buprenorphine Glucuronide (1000 ng/mL): 0.1% cross-reactivity (0.9 ng/mL).
- Norbuprenorphine Glucuronide (1000 ng/mL): 0.1% cross-reactivity (1.2 ng/mL).
Demonstrates good detection of buprenorphine and norbuprenorphine, minimal interference from inactive glucuronide metabolites. |
| Specificity and Cross-reactivity - Structurally Related Compounds - No significant false positives from a panel of common opioids and other structurally related compounds at high concentrations. | Cross-reactivity with Structurally Related Compounds
- Over 20 common opioids and related compounds (e.g., 6-acetylcodeine, codeine, heroin, morphine, oxycodone) were tested at 100,000 ng/mL.
- All tested compounds showed "Negative" qualitative results and "
§ 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).