Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls

K150275 · Immunalysis Corporation · DJG · Mar 9, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150275
• Device Name: Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
• Applicant: Immunalysis Corporation
• Product Code: DJG · Clinical Toxicology
• Decision Date: Mar 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

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.

Device Story

Device is a homogeneous enzyme immunoassay for qualitative detection of 6-Acetylmorphine in human urine. Input: human urine samples. Principle: competitive binding between drug in sample and enzyme-labeled drug conjugate for recombinant antibodies; G6PDH enzyme activity measured via absorbance change. Output: qualitative positive/negative result based on 10ng/mL cutoff. Used in clinical laboratories by technicians/pathologists on automated clinical chemistry analyzers (e.g., Beckman Coulter AU 400e). Results are preliminary; require confirmation by GC-MS or LC/MS. Clinical decision-making relies on confirmed results and professional judgment. Benefits: rapid screening for 6-Acetylmorphine, a heroin metabolite, to assist in toxicology assessment.

Clinical Evidence

Bench testing only. Precision/cutoff characterization (N=80 per concentration) verified 10ng/mL cutoff performance. Specificity/cross-reactivity evaluated against structurally related and non-similar compounds. Interference testing assessed endogenous compounds, pH, and specific gravity; ascorbic acid, sodium chloride, boric acid, and pH 3.0 identified as potential interferences. Method comparison study (N=80 clinical samples) against LC/MS showed 100% agreement.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: recombinant antibodies, G6P, NAD, G6PDH-labeled 6-Acetylmorphine derivative in HEPES buffer with Sodium Azide. Form: liquid, ready-to-use. Cutoff: 10ng/mL. Analyzers: automated clinical chemistry systems. Storage: 2–8°C.

Indications for Use

Indicated for the qualitative analysis of 6-Acetylmorphine in human urine to provide preliminary analytical test results. Intended for laboratory use on automated clinical chemistry analyzers. Prescription use only.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k150275

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.