(51 days)
The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.
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 Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
The assay consists of buffers (1 and 2) and Ivophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial enzyme donor (ED) – 6-Acetylmorphine conjugate: enzyme acceptor (EA), chlorophenol red 3-D-galactopyranoside; stabilizers and preservatives. Calibrators and controls are sold separately.
The document describes the analytical performance of the CEDIA Heroin Metabolite (6-AM) Assay for detecting 6-Acetylmorphine in human urine. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as a target range for each metric, but rather implied by the successful demonstration of performance in each analytical study. The reported device performance is provided in detailed tables for each study.
| Acceptance Criteria (Implied by study objective) | Reported Device Performance (Summary) |
|---|---|
| Precision | Qualitative: |
| - Ability to correctly classify samples at varying concentrations. | - 100% agreement for negative samples from 0 to 7.5 ng/mL (n=80 each). |
| - Low variability in results. | - 100% agreement for positive samples from 12.5 to 21.5 ng/mL (n=80 each). |
| - At 10 ng/mL cutoff: 56 Negative / 24 Positive (n=80), indicating some variability near the cutoff. | |
| Semi-Quantitative: | |
| - 100% agreement for negative samples from 0 to 7.5 ng/mL (n=80 each). | |
| - 100% agreement for positive samples from 12.5 to 21.5 ng/mL (n=80 each). | |
| - At 10 ng/mL cutoff: 42 Negative / 38 Positive (n=80), indicating some variability near the cutoff. | |
| Spike Recovery | Qualitative: |
| - Accurate differentiation of concentrations around the cutoff. | - 7.5 ng/mL (below cutoff): All 20 replicates negative. |
| - 12.5 ng/mL (above cutoff): All 20 replicates positive. | |
| Semi-Quantitative: | |
| - 7.5 ng/mL (below cutoff): All 20 replicates negative. | |
| - 12.5 ng/mL (above cutoff): All 20 replicates positive. | |
| Analytical Recovery and Linearity | - Percent recovery between 97.0% and 113.0% for various concentrations (2 ng/mL to 20 ng/mL). |
| - Consistent performance across the assay range. | |
| Method Comparison and Accuracy (Concordance with LC-MS/MS) | Overall Concordance with LC-MS/MS: 99% |
| - High agreement with a confirmatory method (LC-MS/MS). | Qualitative & Semi-Quantitative Results: |
| - Agreement among Positives: 50/50 = 100%. | |
| - Agreement among Negatives: 49/50 = 98%. | |
| - One discordant sample (Positive by immunoassay, 9.61 ng/mL by LC-MS/MS, attributable to cross-reactivity with high morphine concentration). | |
| Specificity (Cross-Reactivity) | Heroin Metabolite (6-AM) and its metabolites: |
| - Low cross-reactivity to other substances, especially structurally related or unrelated compounds. | - 6-Acetylmorphine: 100% cross-reactivity. |
| - Heroin: 6% cross-reactivity. | |
| Structurally Related or Unrelated Opiate Compounds: | |
| - Generally very low cross-reactivity ( |
§ 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).