IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS

K141406 · Immunalysis Corporation · DJG · Jul 1, 2014 · Clinical Toxicology

Device Facts

• Record ID: K141406
• Device Name: IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
• Applicant: Immunalysis Corporation
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (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. The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay. The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.

Device Story

Device is a homogeneous enzyme immunoassay for detecting Buprenorphine in human urine. Input: human urine samples; processed on automated clinical chemistry analyzers (e.g., Beckman Coulter AU 400e). Principle: competitive binding between Buprenorphine in sample and enzyme-labeled Buprenorphine conjugate for rabbit anti-Buprenorphine antibody binding sites; G6PDH enzyme activity measured spectrophotometrically. Output: qualitative (positive/negative relative to 5ng/mL cutoff) or semi-quantitative concentration result. Used in clinical laboratories by trained personnel. Results provide preliminary screening; require confirmation by GC-MS or LC/MS. Clinical utility: aids in identifying Buprenorphine presence to guide further confirmatory testing and clinical decision-making.

Clinical Evidence

Bench testing only. Precision/cutoff characterization (N=80 per concentration) verified cutoff boundary performance. Specificity/cross-reactivity testing evaluated structurally similar and non-similar compounds. Interference testing identified Boric Acid and Riboflavin as potential sources of false negatives. Method comparison against LC/MS using clinical urine samples showed 100% agreement (40/40 positive, 40/40 negative) for both qualitative and semi-quantitative modes. Stability studies (accelerated and open-vial) support 1-year reagent shelf life and 28-day on-board stability.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: rabbit anti-Buprenorphine antibody, G6P, NAD, and Buprenorphine-G6PDH conjugate in Tris buffer with Sodium Azide preservative. Form factor: liquid, ready-to-use. Connectivity: compatible with automated clinical chemistry analyzers (e.g., Beckman Coulter AU 400e). Storage: 2-8°C.

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of Buprenorphine in human urine to detect drug presence. Intended for laboratory use on automated clinical chemistry analyzers. Requires confirmation by GC-MS or LC/MS for preliminary positive results. 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)

{0}

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

510(k) #: k141406

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.