(59 days)
The CEDIA Heroin Metabolite (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 method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography with tandem 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 lyophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial "enzyme donor" - 6-Acetylmorphine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives.
Here's a summary of the acceptance criteria and study details for the CEDIA Heroin Metabolite (6-AM) Assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Precision | All determinations at concentrations below the cutoff should be negative; all at concentrations above the cutoff should be positive. For cut-off concentration, readings can be mixed. | Qualitative Mode: |
- 0 to 7.5 ng/mL (below cutoff): 80/0 (Negative/Positive) determinations.
- 10 ng/mL (at cutoff): 25/55 (Negative/Positive) determinations.
- 12.5 to 20 ng/mL (above cutoff): 0/80 (Negative/Positive) determinations.
Semi-Quantitative Mode:
- 0 to 7.5 ng/mL (below cutoff): 80/0 (Negative/Positive) determinations.
- 10 ng/mL (at cutoff): 46/34 (Negative/Positive) determinations.
- 12.5 to 20 ng/mL (above cutoff): 0/80 (Negative/Positive) determinations. |
| Spike Recovery | Qualitative: No ± 2SD overlap between samples below, at, and above the cutoff. All replicates of spiked negative and positive controls should be accurately detected.
Semi-quantitative: Spiked samples recover within 80-120% of nominal values. | Qualitative Mode: No ± 2SD overlap between 7.5 ng/mL, 10 ng/mL, and 12.5 ng/mL. All 20 replicates of 7.5 ng/mL were Negative, and all 20 replicates of 12.5 ng/mL were Positive, compared to 10 ng/mL.
Semi-Quantitative Mode: Spiked samples recovered within 80-120% of nominal values (as seen in the Analytical Recovery table). |
| Analytical Recovery and Dilution Linearity | Semi-quantitative mode: Demonstrates ability for sample dilution and QC across the assay range, with acceptable percent recovery. | Average Recovery (%) ranged from 97.3% to 115.6% for target concentrations from 0 to 20 ng/mL. Range of Recovery (%) was also provided. |
| Method Comparison and Accuracy | High concordance (suggesting 100%) between the immunoassay and a confirmatory method (LC-MS/MS) for patient samples across various concentration ranges. | Qualitative & Semi-Quantitative Modes: Overall concordance between LC-MS/MS and CEDIA Heroin Metabolite (6-AM) Assay was 100% for the 103 samples tested. |
| Specificity (Cross-reactivity with Metabolites) | 6-Acetylmorphine shows 100% cross-reactivity and heroin shows appropriate cross-reactivity (e.g., in this case, 8.3%). | 6-Acetylmorphine: 100% cross-reactivity at 10 ng/mL.
Heroin: 8.3% cross-reactivity at 120 ng/mL. |
| Specificity (Cross-reactivity with Structurally Related/Unrelated Compounds) | Structurally related or unrelated compounds should exhibit minimal cross-reactivity (e.g.,
§ 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).