(99 days)
BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.
The 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 or LC/MS is the preferred confirmatory method.
BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only.
The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.
BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch.
BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.
The provided FDA 510(k) summary (K241869) describes the BioSieve™ Fentanyl FIA Home Test Kit, BioSieve™ Fentanyl FIA Pro Test Kit, and BioSieve™ Toxismart Reader. The document focuses on demonstrating substantial equivalence to a predicate device (K240124) and includes details of a lay-user study.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., that the device must meet for clearance. Instead, the performance is demonstrated through a lay-user study, and the implied acceptance is 100% correct results for all tested samples across various concentrations relative to the cutoff.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Lay-user study) |
|---|---|---|
| Accuracy at -100% Cutoff (0 ng/mL Fentanyl) | 100% correct negative results | 100% correct negative results (20/20) |
| Accuracy at -75% Cutoff (0.248 ng/mL Fentanyl) | 100% correct negative results | 100% correct negative results (20/20) |
| Accuracy at -50% Cutoff (0.504 ng/mL Fentanyl) | 100% correct negative results | 100% correct negative results (20/20) |
| Accuracy at -25% Cutoff (0.745 ng/mL Fentanyl) | 100% correct negative results | 100% correct negative results (20/20) |
| Accuracy at +25% Cutoff (1.267 ng/mL Fentanyl) | 100% correct positive results | 100% correct positive results (20/20) |
| Accuracy at +50% Cutoff (1.508 ng/mL Fentanyl) | 100% correct positive results | 100% correct positive results (20/20) |
| Accuracy at +75% Cutoff (1.768 ng/mL Fentanyl) | 100% correct positive results | 100% correct positive results (20/20) |
| Ease of Instructions | Instructions can be easily followed | All lay users indicated instructions were easily followed |
| Reading Grade Level (Package Insert) | Less than 8th-grade level | Less than 8th-grade level (via Flesch-Kincaid) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 140 lay persons (participants). Each participant was provided with 1 blind-labeled sample. The total number of individual urine samples prepared for the study across all concentration levels was $20 \times 7 = 140$ samples.
- Data Provenance: The document states "Urine samples were prepared... by spiking fentanyl into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared (spiked) rather than naturally occurring clinical samples. The country of origin for the data is not specified, but the submitter is VivaChek Biotech (Hangzhou) Co., Ltd. from China. The study appears to be prospective in nature, as it involved lay users actively interacting with the device and samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a panel of experts.
- Qualifications of Experts: The ground truth for the fentanyl concentrations in the prepared urine samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method for quantifying substances, and its operation would typically be performed by trained laboratory personnel/chemists rather than medical experts like radiologists. The document does not specify the qualifications of the individuals who performed the LC/MS analysis. The reference method is considered the "ground truth."
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method involving multiple human readers or a consensus process for the results of the device tests. The lay users performed the tests, and their readings (positive/negative) were compared directly against the LC/MS confirmed concentrations of the spiked samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a lay-user study evaluating the device's performance when used by intended lay users, not a comparison of human readers with and without AI assistance, nor does the device itself involve AI assistance for interpretation beyond the Toxismart Reader's automated reporting.
6. Standalone (Algorithm Only) Performance
Yes, a form of standalone performance was implicitly evaluated. The "lay-user study" assessed the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart Reader system (which includes interpretation by the reader) in an "algorithm only without human-in-the-loop performance" sense, as the lay users were simply operating the device and reading its output. The reader itself performs the detection and displays the result.
7. Type of Ground Truth Used
The ground truth used was analytical confirmation by LC/MS. This is an objective quantitative method considered highly accurate for determining the precise concentration of fentanyl in the spiked urine samples.
8. Sample Size for the Training Set
The document states: "1. Analytical Performance: See analytical performance in predicate K240124. 2. Comparison Studies: See studies in predicate K240124". This implies that the training (or development/optimization) data for the device's analytical performance and the reader's algorithm were part of the predicate device's submission (K240124) and are not detailed in this 510(k) summary. Therefore, the sample size for the training set is not provided in the current document.
9. How the Ground Truth for the Training Set Was Established
Similar to the above, the methods for establishing ground truth for any training set related to the development of the device or reader would be found in the predicate device's documentation (K240124) and are not detailed in this summary. It can be inferred that for a diagnostic device like this, ground truth would likely involve a combination of spiked samples with known concentrations and potentially confirmed clinical samples using a reference method like GC/MS or LC/MS.
§ 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).