(175 days)
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.
The Emit® II Plus 6-Acetylmorphine 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 spectroscopy (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Emit® II Plus 6-AM/Ecstasy Calibrators/Controls:
When used as Calibrators, the materials are for the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays.
When used as Controls, the materials may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogenous enzyme immunoassay with a 10 ng/mL cutoff. The assay, used for the detection of 6-acetylmorphine (a heroin metabolite) in human urine, utilizes a two-reagent system. The Antibody/Substrate Reagent 1 is a liguid ready-to-use product comprised of mouse monoclonal antibodies to 6-acetylmorphine (6-AM), glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a lyophilized product containing 6-AM labeled bacterial recombinant glucose-6-phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers. Reagent 2 is reconstituted with either deionized or distilled water.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers (Reagent 2 is provided in a plastic bag with desiccant) and is available in two sizes. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4:
The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus 6-Acetylmorphine Assay and the Emit® II Plus Ecstasy Assay. These materials may also be used as quality controls based on the specific 6-Acetylmorphine Assay or Ecstasy Assay cutoffs.
The calibrator / control products have the same formulation as the existing Emit® II Plus Ecstasy Calibrators / Controls: cleared under K043028. The matrix is pooled, drug-free. human urine based product containing 6- acetylmorphine (6-AM), methylenedioxymethamphetamine (MDMA) and preservatives. The four levels of product are packaged separately in 15 mL plastic vials with a 10 mL fill per vial.
The multi-analyte Calibrators / Controls Levels 1 through 4 contain 6-AM and MDMA at the following concentrations:
Level 1: Targeted 6-AM Concentration (ng/mL) 5, Targeted MDMA Concentration (ng/mL) 150
Level 2: Targeted 6-AM Concentration (ng/mL) 10, Targeted MDMA Concentration (ng/mL) 300
Level 3: Targeted 6-AM Concentration (ng/mL) 15, Targeted MDMA Concentration (ng/mL) 500
Level 4: Targeted 6-AM Concentration (ng/mL) 20, Targeted MDMA Concentration (ng/mL) 1000
The Emit® Calibrator / Control Level 0, which contains no drug and was cleared under K993755 will also be used with the Emit® II Plus 6- AcetyImorphine Assay. There was no change to the Calibrator Level 0 product.
Acceptance Criteria and Device Performance for Emit® II Plus 6-Acetylmorphine Assay
The Emit® II Plus 6-Acetylmorphine Assay is an in-vitro diagnostic device designed for the qualitative and/or semiquantitative analysis of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. The device's performance was evaluated against a predicate device and confirmed using Gas Chromatography/Mass Spectrometry (GC/MS).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Emit® II Plus 6-Acetylmorphine Assay are implicitly defined by its agreement with GC/MS results for qualitative and semiquantitative analysis, particularly around the 10 ng/mL cutoff. The reported performance demonstrates high agreement with GC/MS.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Agreement | High agreement (ideally >95%) with GC/MS for positive and negative samples, especially near the cutoff. | POS: 98% with GC/MS (for samples >= 10 ng/mL) |
| NEG: 100% with GC/MS (for samples = 10 ng/mL) | ||
| NEG: 100% with GC/MS (for 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).