(134 days)
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000 |
| Cocaine (COC) | Benzoylecgonine | 300 |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET) | d-Methamphetamine | 1000 |
| Opiates(OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.
Here's an analysis of the acceptance criteria and study details from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are implicitly defined by the performance observed in the precision and method comparison studies. The document states that for precision, all test results for samples at and below -25% of the cut-off were negative, and all results for samples at and above +25% of the cut-off were positive. This indicates the device accurately identifies samples substantially below and above the cut-off.
For the method comparison, the device's performance is presented through the concordance with GC/MS results, with discordant results explicitly listed. The overall performance is demonstrated by the number of samples correctly identified as negative or positive across various concentration ranges relative to the cut-off.
Since the document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or overall agreement percentage), the performance reported in the tables below represents how the device met the implied expectation of accurate qualitative detection around the cut-off.
| Test (Analyte) | Cut-off (ng/mL) | Acceptance Criteria (Implicit) | Reported Device Performance Range (Cassettes, Dipcards, Cups) |
|---|---|---|---|
| Precision Study | |||
| AMP, COC, THC, MET, OPI, PCP | (Various, see doc) | - Samples at/below -25% cut-off: All Negative |
- Samples at/above +25% cut-off: All Positive | - Samples at/below -25% cut-off: All Negative
- Samples at/above +25% cut-off: All Positive |
| Method Comparison (Qualitative Performance around Cut-off) | | | |
| AMP | 1000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 17 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
| COC | 300 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 5 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
| MET | 1000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 16 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
| OPI | 2000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 8 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
| PCP | 25 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 8 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
| THC | 50 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes: - Negative Urine, +50% cut-off: 15 Pos, 0 Neg
(Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
2. Sample Size Used for the Test Set and Data Provenance
The studies used unaltered clinical samples for the method comparison. The samples were collected and tested as follows for each analyte and device type (Cassette, Dipcard, Cup):
- AMP: 43 Negative urine samples, 0 samples +50% cut-off. (Total = 95 samples per operator/device)
- COC: 42 Negative urine samples, 0 samples +50% cut-off. (Total = 99 samples per operator/device)
- MET: 43 Negative urine samples, 0 samples +50% cut-off. (Total = 95 samples per operator/device)
- OPI: 45 Negative urine samples, 0 samples +50% cut-off. (Total = 96 samples per operator/device)
- PCP: 45 Negative urine samples, 2 samples +50% cut-off. (Total = 102 samples per operator/device)
- THC: 44 Negative urine samples, 4 samples +50% cut-off. (Total = 105 samples per operator/device)
The total number of unique samples is not directly reported, as these numbers represent the distribution of samples across different concentration ranges. Since "unaltered clinical samples" were used, this suggests they were retrospective in nature. The provenance (country of origin) of the data is not explicitly stated, but the applicant company is based in Hangzhou, China, suggesting the studies were likely performed there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are "preferred confirmatory methods" as stated in the Indications for Use. The document does not specify the number of experts or their qualifications for operating these instruments or interpreting their results; it implies the use of standard laboratory practices for these confirmatory methods.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set results. The comparison is directly between the device's qualitative result (positive/negative) and the quantitative GC/MS or LC/MS result. Discordant results are noted but no further adjudication (e.g., by multiple experts reviewing the same case) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study evaluated the standalone performance of the device against a gold standard (GC/MS/LC/MS), not its effectiveness in assisting human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies conducted were standalone performance evaluations. The device (LYHER® Urine Multi-Drug Test Kit) is a rapid lateral flow immunoassay, which produces a visual result (line present or absent). The "operators" in the study simply interpret this visual result. The results presented are the device's performance as interpreted by an operator, not an AI algorithm. So, while it involves human interpretation of the device's output, it is a standalone performance of the device itself without additional AI assistance beyond the inherent design of the test kit.
7. The Type of Ground Truth Used
The ground truth used was quantitative analytical results from Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are considered highly accurate confirmatory methods for drug detection and concentration.
8. The Sample Size for the Training Set
The document describes "Precision studies" involving spiking drugs into negative samples to achieve concentrations at various percentages around the cut-off. However, this is described as part of the analytical performance characterization and not as a "training set" for an algorithm. This device is a lateral flow immunoassay, not a machine learning or AI-based device, and therefore does not have a "training set" in the conventional sense of an AI model.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, there isn't a "training set" that requires ground truth establishment. For the precision studies mentioned (which are part of analytical performance validation), the "ground truth" was established by spiking known concentrations of the target drug into negative urine samples. These spiked concentrations were then "confirmed by LC/MS" to ensure accuracy of the prepared samples.
§ 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).