(225 days)
The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confirmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures.
This assay provides a preliminary analytical test result. A more specific alternative chemical method must be used in order to confirm an analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/ tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The DRI® Hydrocodone Assay Calibrators are intended for the DRI® Hydrocodone Assay. For In Vitro Diagnostic Use Only.
The DRI® Hydrocodone Controls are unassayed quality control material intended for use in the DRI Hydrocodone Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. For In Vitro Diagnostics Use Only
The DRI® Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Hydrocodone and its metabolites without any significant cross-reactivity to other opiate compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
The DRI® Hydrocodone Assay is a kit comprised of two reagents, Reagent A and Reagent E, which are bottled separately but sold together within the same kit.
The Reagent A solution contains: mouse monoclonal anti-hydrocodone antibody, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide (≤0.09%) as a preservative). The Reagent E solution contains: glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide (≤0.09%) as preservative.
The DRI® Hydrocodone Enzyme Immunoassay calibrators designated for use at the 300 ng/mL cutoff contain 0 (negative), 100, 300, 500, and 1,000 ng/mL of hydrocodone in human urine matrix with sodium azide (≤0.09%) as preservative. The controls are provided at a concentration of 225 and 375 ng/mL. The calibrators are sold separately and the two controls are sold as a kit.
Here's a breakdown of the acceptance criteria and study information for the DRI® Hydrocodone Assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (DRI® Hydrocodone Assay) |
|---|---|---|
| Precision (Qualitative) | All samples below cutoff should read negative. All samples above cutoff should read positive. Samples at cutoff may show variability. | All samples tested recovered accurately. Samples below cutoff read negative, samples above cutoff read positive. At the 300 ng/mL cutoff, for samples spiked at 300 ng/mL (100% of cutoff), 46/80 were negative and 34/80 were positive within run and total run. For samples spiked at 225 ng/mL (-25% of cutoff), all 80 were negative. For samples spiked at 375 ng/mL (+25% of cutoff), all 80 were positive. |
| Precision (Semi-Quantitative) | Similar to qualitative precision for classification, with quantitative results expected to be close to spiked values. | All samples tested recovered accurately. Samples below cutoff read negative, samples above cutoff read positive. At the 300 ng/mL cutoff, for samples spiked at 300 ng/mL (100% of cutoff), 40/80 were negative and 40/80 were positive within run and total run. For samples spiked at 225 ng/mL (-25% of cutoff), all 80 were negative. For samples spiked at 375 ng/mL (+25% of cutoff), all 80 were positive. |
| Accuracy (vs. LC-MS/MS) | High concordance with the reference method, especially for samples not near the cutoff. | Overall concordance between DRI® Hydrocodone Assay and LC-MS/MS was 93%. |
| Linearity/Analytical Recovery | Regression equation close to y=x, with a high R² value. Recovery percentages within an acceptable range (e.g., 80-120%). | Regression equation: y=1.0341-1.9933. R² value: 0.9965. Recovery % for spiked hydrocodone concentrations ranged from 94% to 114%. The results "passed the acceptance criteria" and "demonstrated the values were within the acceptance criteria." |
| Specificity and Cross-Reactivity | Specific detection of hydrocodone and its key metabolites, with minimal or no cross-reactivity from other opiates or common substances at expected concentrations. | Hydrocodone and its active metabolites (Hydromorphone, Hydromorphone-3β-glucuronide) showed high cross-reactivity (102-122%). Other substances tested showed very low (e.g., Norhydrocodone 3.1%, Dihydrocodeine 2.7%, Levorphanol 1.7%, Naloxone 2.0%, NorOxycodone 0.3%, Oxycodone 2.5%, Oxymorphone-6β-D-glucuronide 2.2%, Oxymorphone 2.5%) or negligible ( |
§ 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).