(136 days)
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GCMS or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between EDDP in the sample and EDDP labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the EDDP concentration in the sample is measured in terms of enzyme activity. In the absence of EDDP in the sample, EDDP-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free EDDP is present in the sample, antibody would bind to free EDDP; the unbound EDDP-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains mouse monoclonal anti-methadone metabolite antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with methadone metabolite in buffer with sodium azide (0.09 %) as a preservative.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 250, 500 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0, 150, 225, 300, 375, 600, and 1000 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.
The provided document is a 510(k) premarket notification for the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay and Calibrators. It focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving conformance to them in the same way a de novo or PMA submission might.
Therefore, the acceptance criteria are largely implied by the comparison to the predicate device and the analytical performance data presented. The study aims to show that the new device performs comparably to the predicate and provides accurate results for methadone metabolite detection.
Here's an attempt to extract the requested information based on the provided text, with notable limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (100 ng/mL Cutoff) | Consistency in qualitative results (Negative/Positive) at various concentrations, particularly near the cutoff, demonstrating minimal variation within and between runs. For concentrations 125 ng/mL, results should be consistently positive. At the 100 ng/mL cutoff, a mix of positive and negative results is expected due to inherent variability, but overall agreement with expected ranges should be demonstrated. | Semi-Quantitative Results: |
- 0, 25, 50, 75 ng/mL: 100% Negative (Within Run N=22, Total N=88)
- 100 ng/mL (Cutoff): Within Run: 11 Neg/11 Pos (50%); Total: 40 Pos/48 Neg (45.5% Pos)
- 125, 150, 175, 200 ng/mL: 100% Positive (Within Run N=22, Total N=88)
Qualitative Results:
- 0, 25, 50, 75 ng/mL: 100% Negative (Within Run N=22, Total N=88)
- 100 ng/mL (Cutoff): Within Run: 13 Neg/9 Pos (40.9% Pos); Total: 34 Pos/54 Neg (38.6% Pos)
- 125, 150, 175, 200 ng/mL: 100% Positive (Within Run N=22, Total N=88) |
| Precision (300 ng/mL Cutoff) | Consistency in qualitative results (Negative/Positive) at various concentrations, particularly near the cutoff, demonstrating minimal variation within and between runs. For concentrations 375 ng/mL, results should be consistently positive. At the 300 ng/mL cutoff, a mix of positive and negative results is expected due to inherent variability, but overall agreement with expected ranges should be demonstrated. | Semi-Quantitative Results: - 0, 75, 150, 225 ng/mL: 100% Negative (Within Run N=22, Total N=88)
- 300 ng/mL (Cutoff): Within Run: 6 Neg/16 Pos (72.7% Pos); Total: 52 Pos/36 Neg (59.1% Pos)
- 375, 450, 525, 600 ng/mL: 100% Positive (Within Run N=22, Total N=88)
Qualitative Results:
- 0, 75, 150, 225 ng/mL: 100% Negative (Within Run N=22, Total N=88)
- 300 ng/mL (Cutoff): Within Run: 7 Neg/15 Pos (68.2% Pos); Total: 55 Pos/33 Neg (62.5% Pos)
- 375, 450, 525, 600 ng/mL: 100% Positive (Within Run N=22, Total N=88) |
| Method Comparison - Clinical Samples (100 ng/mL Cutoff) | High concordance with LC/MS results, especially for samples clearly positive or negative relative to the cutoff. Discrepancies should be understood and ideally minimal, particularly for samples significantly above/below the cutoff. The device should demonstrate appropriate sensitivity and specificity compared to a confirmatory method. | Qualitative/Semi-Quantitative Accuracy Study (N=87): - Agreement for 23 Negative, 11
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).