CEDIA Heroin Metabolite (6-AM) Assay

K173183 · Microgenics Corporation · DJG · Nov 22, 2017 · Clinical Toxicology

Device Facts

• Record ID: K173183
• Device Name: CEDIA Heroin Metabolite (6-AM) Assay
• Applicant: Microgenics Corporation
• Product Code: DJG · Clinical Toxicology
• Decision Date: Nov 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The 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 spectrometry (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

Device Story

Homogeneous enzyme immunoassay; detects 6-Acetylmorphine (6-AM) in human urine. Input: urine sample; Reagents: mouse monoclonal antibodies, recombinant microbial enzyme donor (ED)-6-AM conjugate, enzyme acceptor (EA), chlorophenol red-beta-D-galactopyranoside. Principle: EA and ED fragments re-associate to form active enzyme; enzyme cleaves substrate to produce color change measured spectrophotometrically. Used in clinical laboratories by trained professionals. Output: qualitative (positive/negative) or semi-quantitative concentration result. Results serve as preliminary screen; require confirmation via GC/MS or LC-MS/MS. Clinical decision-making relies on professional judgment; aids in identifying heroin use.

Clinical Evidence

Bench testing only. Performance evaluated on Beckman Coulter AU 680 analyzer. Precision (n=80) showed 100% agreement at +/- 25% of cutoff. Method comparison (n=100) against LC-MS/MS demonstrated 99% overall concordance. Specificity testing confirmed 100% cross-reactivity for 6-AM and negligible cross-reactivity for structurally related/unrelated compounds. Interference studies evaluated pH, specific gravity, and endogenous substances; pH 11 was identified as an interferent.

Technological Characteristics

Homogeneous enzyme immunoassay; utilizes recombinant DNA technology (beta-galactosidase fragments). Reagents: mouse monoclonal antibodies, ED-6-AM conjugate, EA, chlorophenol red-beta-D-galactopyranoside. Form: Lyophilized reagents (reconstitution required). Connectivity: Designed for use with clinical chemistry analyzers. Storage: 2-8°C.

Indications for Use

Indicated for in vitro qualitative and/or semi-quantitative screening of heroin metabolite (6-AM) in human urine at 10 ng/mL cutoff. Intended for use by trained laboratory professionals on clinical chemistry analyzers. Requires confirmatory testing (GC/MS or LC-MS/MS) for positive results.

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) #: k173183

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.