(56 days)
InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The InstaStrip Fentanyl Dipstick Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
InstaStrip Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each InstaStrip Fentanyl Test device consists of a Test Strip, a Test Tube, a Dropper and a package insert. Each Test Strip is sealed with sachets of desiccant in an aluminum pouch.
Here's a breakdown of the acceptance criteria and study information for the InstaStrip Fentanyl Rapid Test (Urine) / InstaStrip Fentanyl Dipstick Test (Urine):
1. Acceptance Criteria and Reported Device Performance:
The document indicates a cutoff value of 1.0 ng/mL for fentanyl detection. The performance data is primarily presented through precision studies and a lay-user study, focusing on the device's ability to correctly identify positive and negative samples around this cutoff. While explicit acceptance criteria (e.g., minimum sensitivity/specificity percentages) are not explicitly stated as "acceptance criteria," the reported performance demonstrates the device's accuracy in these studies.
| Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Precision (True Negatives) | |
| (No positive results for concentrations at or below -50% cutoff) | -100% cutoff (0 ng/mL): 60-/0+ across 3 lots |
| -75% cutoff (0.19 ng/mL): 60-/0+ across 3 lots | |
| -50% cutoff (0.50 ng/mL): 60-/0+ across 3 lots | |
| Precision (Near Cutoff Negatives) | |
| (Majority negative results for concentrations between -50% and -25% cutoff, with some tolerance for false positives due to inherent variability near cutoff) | -25% cutoff (0.69 ng/mL): |
| Lot 1: 54-/6+ | |
| Lot 2: 55-/5+ | |
| Lot 3: 55-/5+ | |
| Precision (Near Cutoff Positives) | |
| (Majority positive results for concentrations between +25% and +50% cutoff, with some tolerance for false negatives) | +25% cutoff (1.15 ng/mL): |
| Lot 1: 60+/0- | |
| Lot 2: 60+/0- | |
| Lot 3: 60+/0- | |
| Precision (True Positives) | |
| (All positive results for concentrations at or above +50% cutoff) | +50% cutoff (1.44 ng/mL): 60+/0- across 3 lots |
| +75% cutoff (1.69 ng/mL): 60+/0- across 3 lots | |
| +100% cutoff (2.0 ng/mL): 60+/0- across 3 lots | |
| Lay-user Accuracy (True Negatives) | |
| (100% correct negative identification) | -100% Cutoff (0 ng/mL): 100% correct (0 positive, 20 negative) |
| -75% Cutoff (0.19 ng/mL): 100% correct (0 positive, 20 negative) | |
| -50% Cutoff (0.50 ng/mL): 100% correct (0 positive, 20 negative) | |
| Lay-user Accuracy (Near Cutoff Negative) | |
| (High percentage of correct negative identification allowed for some false positives) | -25% Cutoff (0.69 ng/mL): 95% correct (1 positive, 19 negative) |
| Lay-user Accuracy (True Positives) | |
| (100% correct positive identification) | +25% Cutoff (1.15 ng/mL): 100% correct (20 positive, 0 negative) |
| +50% Cutoff (1.44 ng/mL): 100% correct (20 positive, 0 negative) | |
| +75% Cutoff (1.69 ng/mL): 100% correct (20 positive, 0 negative) | |
| Specificity (Non-interfering substances) | No interference observed for a wide range of common substances at specified concentrations (summarized in tables). |
| Specificity (Cross-reactivity) | Detailed cross-reactivity with various fentanyl analogs and other opioids provided, indicating varying levels of cross-reactivity or no cross-reactivity. |
| Stability | Stable at room temperature for 24 months (based on accelerated stability study). |
| Effect of Urine Specific Gravity and pH | All samples at or above +50% Cut-Off were positive; all samples at or below -50% Cut-Off were negative across tested pH (4-9) and specific gravity (1.000-1.035) ranges. |
2. Sample Size and Data Provenance (Test Set):
-
Precision Studies:
- Sample Size: 60 tests per lot for each of 9 concentration levels (6 tests/day for 10 days per lot). Total: 9 concentrations * 60 tests/lot * 3 lots = 1620 tests.
- Data Provenance: Samples were prepared by spiking fentanyl into negative samples. The origin of the initial negative samples is not specified (e.g., country of origin). The study design implies a laboratory-controlled setting, likely retrospective preparation of spiked samples.
-
Comparison Studies (Method Comparison):
- Sample Size: 85 unaltered clinical samples (42 negative and 43 positive).
- Data Provenance: "clinical samples." The specific country of origin, whether retrospective or prospective, is not mentioned.
-
Lay-user Study:
- Sample Size: 140 lay persons and 140 individual test samples.
- Data Provenance: Urine samples were prepared by spiking fentanyl into drug-free pooled urine specimens. This indicates a laboratory-controlled, simulated-use setting rather than direct patient samples.
3. Number of Experts and Qualifications (Ground Truth for Test Set):
- Precision, Comparison, and Lay-user Studies: The ground truth for fentanyl concentrations in all test samples (spiked or clinical) was established using LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted analytical method for drug confirmation.
- Number of Experts: Not specified. LC/MS analysis is typically performed by trained laboratory technicians or chemists, not clinical "experts" like radiologists. Their "qualification" is their expertise in performing and interpreting LC/MS results.
- Qualifications: Expertise in LC/MS analysis.
4. Adjudication Method (Test Set):
- The document implies that for the precision, comparison, and lay-user studies, the LC/MS results served as the definitive ground truth reference standard against which the device's qualitative results (positive/negative) were compared. There is no mention of a human expert adjudication process (e.g., 2+1, 3+1) for the actual test results from the device itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or complex diagnostic data with and without AI assistance to measure the effect size of AI. The InstaStrip Fentanyl Test is a rapid, qualitative immunoassay where the interpretation is typically straightforward (presence/absence of a line) and not subject to the same kind of reader variability or AI assistance as image interpretation.
6. Standalone Performance (Algorithm Only):
- Yes, standalone performance was evaluated. The device itself (the immunoassay strip) performs the detection without active human-in-the-loop decision-making beyond visual interpretation of the result. The precision studies and comparison studies directly assess this standalone performance against the LC/MS ground truth. The lay-user study then evaluates the standalone performance combined with user interpretation.
7. Type of Ground Truth Used:
- The primary ground truth used throughout the studies (precision, comparison, specificity, cross-reactivity, lay-user) was LC/MS (Liquid Chromatography-Mass Spectrometry), a gold standard analytical method for confirming drug concentrations.
8. Sample Size for the Training Set:
- Not applicable / Not specified. This device is a rapid immunoassay, not a machine learning or AI-based device that typically requires a large "training set" in the same way. The performance characteristics are based on the biochemical reactions and design of the test strip, which are validated through the described analytical and clinical performance studies, not by training a computational model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the development and validation of the immunoassay itself would be based on established analytical chemistry principles and controlled spiking experiments to ensure the antibodies and reagents react appropriately at the desired cutoff.
§ 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).