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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.

• 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

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