(29 days)
CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids is a rapid test for the qualitative detection of Oxycodone and Cannabinoids in human urine at a cutoff concentration of 100 ng/mL and 50 ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use.
The test may yield preliminary positive results even when the prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
The CR3 Keyless Split Sample Cup Oxycodone -Cannabinoids test uses immunochromatographic assays for Oxycodone and Cannabinoids. The test is a lateral flow system for the qualitative detection of oxycodone and cannabinoids in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for overall device performance in a pass/fail manner. Instead, it presents various performance characteristics intended to demonstrate substantial equivalence to a predicate device. I will infer performance goals from the reported data.
| Performance Characteristic | Acceptance Criteria (Inferred from data/standards) | Reported Device Performance (Oxycodone) | Reported Device Performance (Cannabinoids) |
|---|---|---|---|
| Precision | Consistent results across concentrations and operators | At cut-off: 42-43 positives/7-8 negatives (out of 50 total detections per lot) | At cut-off: 42-43 positives/7-8 negatives (out of 50 total detections per lot) |
| 100% agreement for concentrations +/-100% of cut-off outside the gray zone | 100% agreement (50-/0+ for -100% to -25% cut-off; 50+/0- for +25% to +100% cut-off) | 100% agreement (50-/0+ for -100% to -25% cut-off; 50+/0- for +25% to +100% cut-off) | |
| Cut-off Verification | All samples at +25% and +50% cut-off are positive. All samples at -25% and -50% cut-off are negative. | All positive at +25% and +50% cut-off. All negative at -25% and -50% cut-off. | All positive at +25% and +50% cut-off. All negative at -25% and -50% cut-off. |
| Interference | No interference from common physiological substances. | No interference reported for a list of 60+ substances at 100µg/mL. | No interference reported for a list of 60+ substances at 100µg/mL. |
| Specificity | Demonstrate cross-reactivity for related compounds, if any. | Oxycodone: 100%, Dihydrocodeine: 0.5%, Hydrocodone: 1%, Oxymorphone: 10%, Codeine: 0.1%, Hydromorphone: 0.1%. No detection for Morphine, Acetylmorphine, Buprenorphine, Ethylmorphine, Thebaine. | 11-nor-Δ9-THC-9-COOH: 100%, 11-nor-Δ8-THC-9-COOH: 167%, 11-hydroxy-Δ9-Tetrahydrocannabinol: 2%, (-)-11-nor-9-carboxy-Δ9-THC: 100%, 11-nor-Δ9-THC-carboxyglucuronide: 50%, Δ8- Tetrahydrocannabinol: 0.6%, Δ9- Tetrahydrocannabinol: 0.5%, Cannabinol: 0.05%, Cannabidiol: 0.05%. |
| Effects of Specific Gravity & pH | Device performance not affected by varying specific gravity (1.000-1.035) and pH (4.00-9.00). | Performance found not affected. | Performance found not affected. |
| Method Comparison (Professional User) | High agreement with GC/MS, especially outside the "near cutoff" range. Acceptable discordance near cut-off. | For Oxycodone (cutoff 100 ng/mL): Good agreement (many 0 negatives for positive, many 0 positives for negative). Discordant samples typically within +/-5% of cutoff. | For Cannabinoids (cutoff 50 ng/mL): Good agreement (many 0 negatives for positive, many 0 positives for negative). Discordant samples typically within +/-5% of cutoff. |
| Lay-User Study Agreement with GC/MS | High agreement rate, particularly for drug-free and concentrations significantly above/below cut-off. | Oxycodone: 100% for drug-free, -75%, -50%, +50%, +75%. 85% for -25% and +25%. | Cannabinoids: 100% for -75%, -50%, +50%, +75%. 85% for -25% and +25%. |
| Lay-User Study Ease of Use | Instructions can be easily followed. Flesch-Kincaid reading grade level |
§ 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).