Emit II Plus Oxycodone Assay
Device Facts
| Record ID | K172910 |
|---|---|
| Device Name | Emit II Plus Oxycodone Assay |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Oct 18, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K172910 · Oct 18, 2017 | Emit II Plus Oxycodone Assay | Siemens Healthcare Diagnostics, Inc. | Unaltered native patient urine samples | The sponsor used 100 clinical patient samples to perform a method comparison between the proposed assay and LC-MS/MS to demonstrate clinical performance and substantial equivalence. | Method comparison; Clinical patient samples; Urine specimens |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective method comparison | Patients providing urine samples; Sample Size: 100 | Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) | Qualitative and semiquantitative agreement with LC-MS/MS |
Indications for Use
The Emit® II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay is intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. The Emit® II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures. The Emit® II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Device Story
The Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay used for the preliminary detection of oxycodone in human urine. It utilizes a two-reagent system: Reagent 1 contains mouse monoclonal anti-oxycodone antibodies, glucose-6-phosphate (G6P), and NAD; Reagent 2 contains oxymorphone labeled with bacterial recombinant glucose-6-phosphate dehydrogenase (rG6PDH). The assay is designed for use on clinical chemistry analyzers. In the presence of oxycodone in a urine sample, the drug competes with the enzyme-labeled drug for antibody binding sites, modulating enzyme activity. The resulting change in absorbance is measured spectrophotometrically. The device provides qualitative or semiquantitative results. Semiquantitative results assist laboratories in determining appropriate specimen dilutions for confirmatory testing (e.g., LC/MS or GC/MS). The assay is intended for professional use in clinical laboratory settings. It aids healthcare providers by providing preliminary screening data for clinical decision-making regarding drug use, though it requires confirmation by more specific chemical methods.
Clinical Evidence
Bench testing only. Method comparison study of 100 patient samples per cutoff against LC-MS/MS showed 93-98% agreement for positives and 98-100% for negatives. Precision evaluated per CLSI EP05-A3 (n=80 per level). Recovery, cross-reactivity, and interference studies (endogenous substances, structurally related/unrelated compounds) confirmed performance within specifications.
Technological Characteristics
Homogeneous enzyme immunoassay. Two-reagent liquid, ready-to-use system. Reagents contain mouse monoclonal anti-oxycodone antibodies, G6P, NAD, and rG6PDH-labeled oxymorphone. Analyzers measure absorbance changes. Storage 2°C to 8°C. No specific software algorithm class stated; standard clinical chemistry analyzer photometric processing.
Indications for Use
Indicated for the qualitative and semiquantitative determination of oxycodone in human urine for in vitro diagnostic use. Intended for use with clinical chemistry analyzers to provide preliminary analytical results requiring confirmation by GC/MS or LC/MS.
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).
