(88 days)
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale. The test detects oxycodone at concentrations 100 ng/mL and above. THE MEDTOX® OXYCODONE 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) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT.
Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold, When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.
MEDTOX® OXYCODONE Test System: Acceptance Criteria and Performance Study Summary
This document describes the acceptance criteria and performance study results for the MEDTOX® OXYCODONE Test System, an immunochromatographic test strip for the rapid, qualitative detection of oxycodone in human urine. The information is extracted from the 510(k) summary K060351.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| 75% below cutoff (25 ng/mL) | Consistent negative results | 100% negative results |
| 50% below cutoff (50 ng/mL) | Majority negative results | 93% negative results |
| At cutoff (100 ng/mL) | Majority positive results (or clear distinction at cutoff) | 93% positive results |
| 25% above cutoff (125 ng/mL) | Consistent positive results | 98% positive results |
| 50% above cutoff (150 ng/mL) | Consistent positive results | 100% positive results |
| Point-of-Care (POC) Precision | Similar performance to in-house professional study | "Similar to the professional study" for most levels; consistent at 0 and 150 ng/mL |
| **Analytical Specificity | ||
| (Cross-Reactivity)** | Oxycodone: Positive at 100 ng/mL (100% reactivity) | |
| Oxymorphone: Significant cross-reactivity expected (compared to predicate) | ||
| Other opiates/compounds: Low or no cross-reactivity | Oxycodone: Positive at 100 ng/mL (100% reactivity) | |
| Oxymorphone: Positive at 200 ng/mL (50% reactivity) | ||
| Codeine: Positive at 5,000 ng/mL (2%) | ||
| Ethylmorphine: Positive at 5,000 ng/mL (2%) | ||
| Dihydrocodeine: Positive at 10,000 ng/mL (1%) | ||
| Hydrocodone: Positive at 75,000 ng/mL ( |
§ 862.3650 Opiate test system.
(a)
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.(b)
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).