(33 days)
The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only.
The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. particularly when preliminary positive results are used.
Immunalysis 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay.
Immunalysis 6-Acetylmorphine Urine Calibrator: The Immunalysis 6-Acetylmorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to 6-Acetylmorphine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes 6-AcetyImorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative. Calibrator and controls are sold separately. Reagents are liquid, ready to use
The 6-AcetyImorphine calibrator and controls consist of a cutoff calibrator at 10ng/mL, a LOW control at 7.5ng/mL for the 10ng/mL cutoff and a HIGH control at 12.5ng/mL for the 10ng/mL cutoff.
The Immunalysis 6-acetylmorphine Urine Enzyme Immunoassay is intended for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers, with a cutoff of 10ng/mL. The study performed to establish substantial equivalence included tests for precision/cutoff characterization, specificity and cross-reactivity, interference, and method comparison.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a dedicated table. However, performance can be inferred from the results presented. The device aims to accurately classify samples as negative or positive for 6-Acetylmorphine based on the 10ng/mL cutoff.
| Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision/Cutoff Characterization | All samples at -25% to -100% of cutoff should be negative. All samples at +25% to +100% of cutoff should be positive. Samples at cutoff (10ng/mL) should show a distribution around 50% positive/negative, demonstrating the cutoff as a boundary. | Table 1: Qualitative Analysis (for 10ng/mL cutoff) |
- 0 to 7.5 ng/mL ( -100% to -25% of cutoff): 80/80 Negative results for each concentration.
- 10 ng/mL (Cutoff): 43 Negative / 37 Positive (demonstrates the cutoff as a boundary).
- 12.5 to 20 ng/mL (+25% to +100% of cutoff): 80/80 Positive results for each concentration.
Conclusion: Meets inferred criteria. |
| Specificity and Cross-Reactivity | Structurally similar compounds should show expected cross-reactivity or non-cross-reactivity. Structurally dissimilar compounds should not interfere. | Table 2: Structurally Related Compounds (for 10 ng/mL cutoff) - Qualitative - 6-Acetylmorphine (10 ng/mL): 100% cross-reactivity (Positive result).
- 6-Acetylcodeine (600 ng/mL): 1.7% cross-reactivity (Positive result).
- Heroin (1,375 ng/mL): 0.7% cross-reactivity (Positive result).
- Hydromorphone (325,000 ng/mL): 0.003% cross-reactivity (Positive result).
- Morphine (285,000 ng/mL): 0.000035% cross-reactivity (Positive result).
- Nalorphine (80,000 ng/mL): 0.0125% cross-reactivity (Positive result).
- Naloxone (300,000 ng/mL): 0.00333% cross-reactivity (Positive result).
- Naltrexone (390,000 ng/mL): 0.00256% cross-reactivity (Positive result).
- Normorphine (250,000 ng/mL): 0.004% cross-reactivity (Positive result).
- Oxymorphone (360,000 ng/mL): 0.00277% cross-reactivity (Positive result).
- Other listed compounds showed "Negative" results or N.D. (Not Determined).
Conclusion: Meets inferred criteria, with predictable cross-reactivity for related opioids at higher concentrations, and no unexpected cross-reactivity for others. |
| Interference | Structurally non-similar compounds, endogenous compounds, and variations in pH and specific gravity should not cause interference, maintaining the correct classification of samples at ±25% of the cutoff. Exceptions should be noted. | Tables 3 & 4: Structurally Non-Similar Compounds & Endogenous Compounds (for 10ng/mL cutoff) - Majority of compounds (e.g., Acetaminophen, Alprazolam, Caffeine, Ibuprofen) showed "No Interference" at concentrations up to 500,000 ng/mL for -25% and +25% cutoff samples.
- Interferences noted: Ascorbic Acid (1.5 g/dL) caused interference at +25% cutoff (negative result when it should be positive), and at -50% cutoff (negative result when it should be positive). Sodium Chloride (6.0 g/dL) caused interference at +25% cutoff (negative result when it should be positive). Boric Acid (1% w/v) caused interference at +25% and +50% cutoffs (negative result when it should be positive).
- Table 8: Effect of pH
- pH 3.0 caused interference at +25% cutoff (negative result when it should be positive), and at +50% cutoff (negative result when it should be positive). pH values from 4.0 to 11.0 showed no interference.
- Table 10: Effect of Specific Gravity
- No interference was observed for specific gravity values from 1.000 to 1.030.
Conclusion: Meets inferred criteria for most compounds, pH, and specific gravity. Identifiable interferences (Ascorbic Acid, Sodium Chloride, Boric Acid, low pH) are explicitly noted. |
| Method Comparison | 100% agreement between the test device (qualitative results) and the confirmatory method (LC/MS) for samples around the cutoff. | Tables 11: Method Comparison (for 10ng/mL cutoff) - Qualitative - LC/MS Confirmation: 40 Positive, 40 Negative.
- Test Device: 40 Positive, 40 Negative.
- Agreement: 100% agreement (40 True Positives, 40 True Negatives).
- Qualitative/Positive: 100% agreement (4 samples 10-15 ng/mL, 36 samples >15 ng/mL correctly identified as positive).
- Qualitative/Negative: 100% agreement (36 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).