(175 days)
Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.
Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
The provided document is a 510(k) summary for the Dochek® Fentanyl Urine Test System. It describes the device's performance through various studies.
Here's an analysis of the acceptance criteria and study details:
Device: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus
Intended Use: Qualitative detection of Fentanyl (FTY) in human urine at a cut-off concentration of 1 ng/mL for in vitro diagnostic (OTC) use.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance data from various studies. For the purpose of this response, I will consider a general expectation for such devices to perform accurately around the cutoff.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Precision/Reproducibility | Expected high agreement for samples significantly above/below cutoff; some variability near cutoff. | For all device types and lots, 0ng/mL, 0.25ng/mL, 0.5ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL showed 100% agreement. Samples at 0.75ng/mL and 1.25ng/mL (near cutoff) showed expected variability (ranging from 86.7% to 100% agreement for negative/positive results respectively). |
| Analytical Specificity | Low cross-reactivity with structurally similar compounds; no interference from common medications/substances. | Detailed list of cross-reactivity percentages provided, indicating acceptable specificity. No interference was shown from a comprehensive list of opioids and commonly ingested medications/substances. |
| Method Comparison | High agreement with a confirmed analytical method (LC/MS). | Overall agreement rates with LC/MS were consistently 97.5% for all device types and all lots/operators. Discordant results were very close to the cutoff concentration. |
| Lay Person Study | High agreement from lay users interpreting the test results. | Agreement rates ranged from 92.5% to 100% across all concentrations and device types. Near-cutoff samples showed slightly lower, but still high, agreement. |
| Stability | Device remains effective over its shelf-life. | Stable at 2-30°C for 24 months based on real-time stability study. |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility Study:
- Test Set Size: For each concentration (0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL), 60 determinations were made per lot, with two operators independently reading results, leading to 60 results per concentration per lot. With 3 lots, this is 180 determinations per concentration, or 360 individual readings (across two operators).
- Data Provenance: The specimens were "drug-free specimens spiked with Fentanyl." No specific country of origin is mentioned, but the study was conducted over 10 non-consecutive days using three different lots of the device. This appears to be a prospective study using prepared samples.
- Method Comparison Study:
- Test Set Size: 80 clinical urine specimens were used. These were analyzed by LC/MS and by 3 lots of each Dochek® Fentanyl Urine Test product (Strip, Card, Cup). Therefore, for each device type, 80 samples were tested 3 times (once per lot/operator).
- Data Provenance: "Clinical urine specimens." No specific country of origin is mentioned. This appears to be a retrospective study using existing clinical samples.
- Lay Person Study:
- Test Set Size: 980 lay persons participated. For each concentration (0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL), the number of determinations per lot was 40 for the Strip and Cup, and 30 for the Card (cassette and dipcard). Each participant tested one blind-labeled sample.
- Data Provenance: The urine samples were "prepared at the following concentrations... by spiking target drug fentanyl into drug free urine specimens." This indicates samples were prepared for the study. No specific country of origin is mentioned for the lay persons, but the study was conducted at "three intended user sites." This appears to be a prospective study using artificially prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Precision/Reproducibility Study: The ground truth for concentrations (0ng/mL, 0.25ng/mL, etc.) was established by LC-MS/MS. The document does not specify the number or qualifications of experts operating the LC-MS/MS. Device results were read in duplicate by "two different operators," but these are device operators, not ground truth experts.
- Method Comparison Study: The ground truth was established by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS. The study was conducted by "3 laboratory professionals at the manufacturer site" who performed the Dochek® tests.
- Lay Person Study: The ground truth for sample concentrations was confirmed by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS.
4. Adjudication Method for the Test Set:
- Precision/Reproducibility Study: Results for the Dochek device were "read in duplicate by two different operators." It doesn't explicitly state an adjudication method (e.g., 2+1, 3+1). It seems individual operator readings were recorded per sample.
- Method Comparison Study: The document lists results for "Lot 1, operator 1," "Lot 2, operator 2," and "Lot 3, operator 3" separately. This suggests that each operator's reading for each lot was compared directly to the LC/MS benchmark, rather than an adjudication among the operators' readings for a single sample.
- Lay Person Study: Each participant was given one device and one blind-labeled sample. The "Layer user Results" are presented as total positive/negative counts. There's no mention of adjudication among lay users' interpretations for the same sample.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
No MRMC comparative effectiveness study was mentioned. The device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic. Thus, questions regarding human reader improvement with AI assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is a standalone, read by a human. There is no algorithm component described that would operate without human-in-the-loop for reading the results. The studies assess the performance of the device as it is intended to be used (i.e., with human interpretation).
7. The Type of Ground Truth Used:
The primary ground truth method used across all studies (precision, method comparison, and lay person) was LC/MS or LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical chemistry method for identifying and quantifying substances.
8. The Sample Size for the Training Set:
The document describes performance studies for premarket notification. It does not mention a "training set" in the context of machine learning or AI. The product is a diagnostic device, and the data presented are for validation and verification, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for an algorithm, this question is not applicable. The ground truth for the various performance evaluation samples (spiked samples, clinical samples) was established through LC/MS or LC-MS/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).