(28 days)
CR3 Keyless Split Sample Cup Morphine-Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 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 CR3 Keyless Split Sample Cup Morphine-Methamphetamine 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 Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine 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.
The acceptance criteria and the study proving the device meets these criteria are detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the overall device performance in a consolidated table. However, implied acceptance criteria can be derived from the precision and lay-user study results, particularly around the cutoff concentrations. For the purpose of this response, I will synthesize the observed performance from the precision and lay-user studies as the "reported device performance" against common expectations for such devices.
Implied Acceptance Criteria and Reported Device Performance for Morphine (MOP) and Methamphetamine (MET) Detection:
| Criteria Category | Specific Criterion (Implied) | Reported Device Performance (Morphine) | Reported Device Performance (Methamphetamine) |
|---|---|---|---|
| Precision (Analytical) | Accurate detection near cut-off (300 ng/mL for MOP, 1000 ng/mL for MET) across multiple lots and operators. | - At Cut-off: 84-86% positive (42-43+/8-7-) out of 50 tests per lot. |
- +25% to +100% Cut-off: 100% positive (50+/0-) per lot.
- -100% to -25% Cut-off: 100% negative (50-/0+) per lot. | - At Cut-off: 84-86% positive (42-43+/8-7-) out of 50 tests per lot.
- +25% to +100% Cut-off: 100% positive (50+/0-) per lot.
- -100% to -25% Cut-off: 100% negative (50-/0+) per lot. |
| Cut-off Verification | All samples -25% and -50% of cut-off should be negative; all samples +25% and +50% of cut-off should be positive. | All samples at -25% and -50% cut-off were negative. All samples at +25% and +50% cut-off were positive. | All samples at -25% and -50% cut-off were negative. All samples at +25% and +50% cut-off were positive. |
| Lay-User Accuracy | High agreement with GC/MS, especially at and away from cut-off. | - -100% to -50% Cut-off: 100% agreement. - -25% Cut-off: 85% agreement (17 negative, 3 positive).
- +25% Cut-off: 85% agreement (3 negative, 17 positive).
- +50% to +75% Cut-off: 100% agreement. | - -100% to -50% Cut-off: 100% agreement.
- -25% Cut-off: 85% agreement (17 negative, 3 positive).
- +25% Cut-off: 85% agreement (3 negative, 17 positive).
- +50% to +75% Cut-off: 100% agreement. |
| Lay-User Usability | Clear instructions, easy to follow. | All lay users indicated instructions were easy to follow. Flesch-Kincaid grade level
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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).