(30 days)
The FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/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.
The FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
The provided text is a 510(k) summary for the FaStep™ Fentanyl Rapid Test Device (Urine), an in vitro diagnostic device. It details the device's technical specifications and performance characteristics through analytical and lay-user studies. It does not describe a clinical study comparing human readers with and without AI assistance (MRMC study), nor does it involve the use of AI. Therefore, the information typically associated with acceptance criteria and studies for AI-powered devices, such as specific performance metrics like AUC, sensitivity, specificity for diagnostic accuracy in a clinical setting, or expert consensus and adjudication methods for ground truth, is not directly applicable or present in this document.
However, I can extract the relevant information from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting to the context of a rapid diagnostic test.
Here’s the breakdown based on the provided text, focusing on the analytical and lay-user performance of the rapid immunoassay:
Acceptance Criteria and Device Performance (Adapted for a Rapid Diagnostic Test)
The primary performance evaluation in this document centers around the device's ability to accurately detect fentanyl in urine at a specific cut-off concentration (1.0 ng/mL) under various conditions. The "acceptance criteria" are implied by the desired accuracy rates at and around this cut-off, as demonstrated in the precision and lay-user studies.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Study/Parameter | Implied Acceptance Criteria (e.g., High Agreement, Low False Results) | Reported Device Performance (from Precision Study) - Example Lot 1 | Reported Device Performance (from Lay-User Study) |
|---|---|---|---|
| Precision (Analytical Performance) | Minimal false positives/negatives at concentrations far from cutoff; Balanced detection around cutoff. | ||
| -100% cut off (0 ng/mL) | Ideal: 100% Negative | 60-/0+ (100% Negative) | 100% Correct (Negative) |
| -75% cut off (0.25 ng/mL) | Ideal: 100% Negative | 60-/0+ (100% Negative) | 100% Correct (Negative) |
| -50% cut off (0.5 ng/mL) | Ideal: 100% Negative | 60-/0+ (100% Negative) | 100% Correct (Negative) |
| -25% cut off (0.75 ng/mL) | Ideal: Predominantly Negative, some positive acceptable around cutoff | 58-/2+ (96.7% Negative; 3.3% False Positive) | 95% Correct (Predominantly Negative, 1 false positive out of 20) |
| Cut off (1.0 ng/mL) | Ideal: Mix of Positive/Negative, indicating performance at threshold | 35+/25- (58.3% Positive; 41.7% False Negative) | N/A (not directly presented for lay-user study as a 'cutoff' row) |
| +25% cut off (1.25 ng/mL) | Ideal: Predominantly Positive, some negative acceptable around cutoff | 60+/0- (100% Positive) | 100% Correct (Positive) |
| +50% cut off (1.5 ng/mL) | Ideal: 100% Positive | 60+/0- (100% Positive) | 100% Correct (Positive) |
| +75% cut off (1.75 ng/mL) | Ideal: 100% Positive | 60+/0- (100% Positive) | 100% Correct (Positive) |
| +100% cut off (2.0 ng/mL) | Ideal: 100% Positive | 60+/0- (100% Positive) | N/A (not directly presented for lay-user study) |
| Interference | No interference from common substances at specified concentrations. | "Compounds that showed no interference at a concentration of 100µg/mL or specified concentrations are summarized..." (List provided, indicating no interference). | Not applicable. |
| Specificity | Minimal cross-reactivity with structurally similar compounds; no cross-reactivity with unrelated opioids. | Minimum concentrations causing positive results for related compounds vary; "Negative results were obtained for all these compounds [unrelated opioids]. There is no cross-reactivity..." | Not applicable. |
| Stability | Device remains stable over stated shelf life. | "The devices are stable at 36-86F for 24 months based on the real-time stability study." | Not applicable. |
| Lay-User Instructions | Instructions are easy to understand and follow for lay users. | 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).