(51 days)
The ARK EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The semiquantitative 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 EDDP 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 EDDP Assay is a homogeneous enzyme immunoassay technique used for the analysis of EDDP in human urine. The assay is based on competition between EDDP in the specimen and EDDP labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of EDDP from the specimen, enzyme activity increases and is directly related to the EDDP 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 EDDP Assay consists of reagents R1 anti-EDDP rabbit antibody with substrate and R2 EDDP derivative labeled with bacterial recombinant G6PDH enzyme.
Here's a breakdown of the acceptance criteria and study details for the ARK EDDP Assay, based on the provided FDA 510(k) summary:
This document describes a medical device, the ARK EDDP Assay, which is an immunoassay for the qualitative and/or semi-quantitative determination of EDDP (a methadone metabolite) in human urine. The study presented is a non-clinical performance evaluation, as indicated by "Brief Description of Nonclinical and Clinical Data" and the nature of the tests (Precision, Analytical Recovery, Analytical Specificity, Interference, etc.). No clinical study involving human patients or human readers in an MRMC setting is described.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific pass/fail values for each performance characteristic. Instead, performance is evaluated against expected behaviors for an in vitro diagnostic (IVD) device of this type. The inferred acceptance criteria are that the device should demonstrate acceptable precision, accurate analytical recovery, appropriate cross-reactivity and interference profiles, and good agreement with a gold standard (GC/MS) in method comparison for qualitative and semi-quantitative results.
| Performance Characteristic | Inferred Acceptance Criteria (Implicit) | Reported Device Performance and Discussion |
|---|---|---|
| Precision | Consistent qualitative and semi-quantitative results, particularly around the cutoff concentrations. | 100 ng/mL Cutoff: |
| - Qualitative (100 ng/mL) | All samples ≤ 75 ng/mL should be negative; all samples ≥ 125 ng/mL should be positive. Samples at 100 ng/mL (cutoff) may show mixed results. | At 0.0, 25.0, 50.0, and 75.0 ng/mL, all 160 results were Negative. At 125.0, 150.0, 175.0, and 200.0 ng/mL, all 160 results were Positive. At the 100.0 ng/mL cutoff, 123 were Negative and 37 were Positive, which is expected for a cutoff concentration. |
| - Semiquantitative (100 ng/mL) | Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff. | Mean concentrations were close to theoretical (e.g., 98.1 ng/mL for 100 ng/mL theoretical). At 100.0 ng/mL cutoff, 114 were Negative and 46 were Positive, consistent with a cutoff. |
| - Qualitative (300 ng/mL) | All samples ≤ 225 ng/mL should be negative; all samples ≥ 375 ng/mL should be positive. Samples at 300 ng/mL (cutoff) may show mixed results. | At 0.0, 75.0, 150.0, and 225.0 ng/mL, all 160 results were Negative. At 375.0, 450.0, 525.0, and 600.0 ng/mL, all 160 results were Positive. At the 300.0 ng/mL cutoff, 57 were Negative and 103 were Positive, which is expected. |
| - Semiquantitative (300 ng/mL) | Mean measured concentrations should be close to theoretical values. Expected mixed qualitative results at cutoff. | Mean concentrations were close to theoretical (e.g., 298.8 ng/mL for 300 ng/mL theoretical). At 300.0 ng/mL cutoff, 85 were Negative and 75 were Positive, consistent with a cutoff. |
| Analytical Recovery | Measured concentration should be within an acceptable percentage range of the theoretical concentration. | Recovery percentages ranged from 94.6% to 107.9% across EDDP concentrations from 50.0 to 1000.0 ng/mL, indicating good analytical recovery. |
| Analytical Specificity | Minimal to no cross-reactivity with structurally related and unrelated compounds, ensuring specificity for EDDP. | Structurally Related Compounds: EDDP showed 100% cross-reactivity (as expected). Methadone and EMDP showed very low cross-reactivity ( |
§ 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).