(147 days)
The ARK Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures.
The ARK Hydrocodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
The ARK Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay is based on competition between hydrocodone in the specimen and hydrocodone labeled with recombinant glucose-o-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of hydrocodone from the specimen, enzyme activity increases and is directly related to the hydrocodone concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Hydrocodone Assay consists of reagents R1 anti-hydrocodone monoclonal rabbit antibodies with substrate and R2 hydrocodone derivative labeled with bacterial recombinant G6PDH enzyme.
The provided document is a 510(k) summary for the ARK Hydrocodone Assay, an immunoassay for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly define formal "acceptance criteria" in a separate table with numerical thresholds for accuracy, precision, etc. Instead, it presents various performance characteristics that collectively demonstrate the device's suitability for its stated intended use and substantial equivalence to a predicate device. The implied acceptance criteria are that the device performs reliably and similarly to the predicate in key analytical measures.
Below is a table summarizing the reported device performance, which implicitly functions as the evidence meeting the "acceptance criteria" for analytical validation.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Qualitative) | Consistent classification (Positive/Negative) at specified concentrations relative to the 300 ng/mL cutoff, especially near the cutoff. | 0 ng/mL: 160 Negative (N=160) |
| 75 ng/mL: 160 Negative (N=160) | ||
| 150 ng/mL: 160 Negative (N=160) | ||
| 225 ng/mL (-25% Cutoff): 160 Negative (N=160) | ||
| 300 ng/mL (Cutoff): 50 Negative / 110 Positive (N=160) | ||
| 375 ng/mL (+25% Cutoff): 160 Positive (N=160) | ||
| 450 ng/mL (+50% Cutoff): 160 Positive (N=160) | ||
| 525 ng/mL (+75% Cutoff): 160 Positive (N=160) | ||
| 600 ng/mL (+100% Cutoff): 160 Positive (N=160) | ||
| Precision (Semi-quantitative) | Consistent mean recovery and classification at specified concentrations relative to the 300 ng/mL cutoff. | 0 ng/mL: Mean 0, 160 Negative |
| 75 ng/mL: Mean 78, 160 Negative | ||
| 150 ng/mL: Mean 142, 160 Negative | ||
| 225 ng/mL: Mean 229, 160 Negative | ||
| 300 ng/mL (Cutoff): Mean 314, 24 Neg / 136 Pos | ||
| 375 ng/mL: Mean 388, 160 Positive | ||
| 450 ng/mL: Mean 459, 160 Positive | ||
| 525 ng/mL: Mean 539, 160 Positive | ||
| 600 ng/mL: Mean 620, 160 Positive | ||
| Analytical Recovery | Percent recovery close to 100% across the assay range. | Ranges from 86% to 103% (e.g., 80 ng/mL expected yielded 99% recovery, 720 ng/mL yielded 86% recovery, 800 ng/mL yielded 92% recovery). |
| Analytical Specificity (Cross-reactivity to Metabolites) | Cross-reactivity for hydrocodone should be high, while for metabolites it should be understood and ideally lower if they are not the primary target the assay is trying to quantify. | Hydrocodone: 103% |
| Hydromorphone: 100% | ||
| Hydromorphone-3β-Glucuronide: 0.7% | ||
| Norhydrocodone: 13.2% | ||
| Dihydrocodeine: 100,000 ng/mL tested) | ||
| Analytical Specificity (Cross-reactivity to Structurally Related/Unrelated Compounds) | No significant cross-reactivity with other common opiate compounds or structurally unrelated substances should lead to false positives at specified concentrations. | All 30 tested structurally related or unrelated opiate compounds (e.g., Morphine, Codeine, Fentanyl, Oxycodone, Methadone, Buprenorphine, Heroin) showed NEGATIVE results at concentrations up to 100,000 ng/mL, with cross-reactivity generally 450 ng/mL by LC-MS/MS) correctly identified as Positive. |
| Discordant Results: 8 samples ( |
§ 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).