Search Results

AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL.

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. For in vitro diagnostic use only.

The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL.

This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only.

AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the AllSource Drug Detector Fentanyl Test:

Device: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Indications for Use: Qualitative detection of Fentanyl in human urine at the cutoff concentration of 1 ng/mL. Provides preliminary test results, requiring further confirmatory methods (GC/MS or LC/MS). For in vitro diagnostic use only. For Over-The-Counter Use.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined table with numerical targets for each performance characteristic. Instead, device performance is presented and implicitly deemed acceptable by the FDA for substantial equivalence. The following table synthesizes the performance characteristics presented in the document:

2. Sample Sizes and Data Provenance

• Test Set (Clinical Samples for Method Comparison):

  • Sample Size: 80 "unaltered clinical samples" per site, tested at three different testing sites. This implies a total of 240 samples (80 samples * 3 sites). Each set of 80 consisted of 40 negative and 40 positive samples.
  • Data Provenance: The document does not explicitly state the country of origin. It indicates they were "unaltered clinical samples," suggesting they were collected from human subjects. It does not specify whether they were retrospective or prospective, but the term "unaltered clinical samples" often implies retrospectively collected samples that were then blinded for the study.

• Test Set (Lay-User Study):

  • Sample Size: 140 "lay persons" tested with aliquoted and blinded samples. The table shows 20 samples per concentration level, for a total of 7 concentration levels ( -100%, -75%, -50%, -25%, +25%, +50%, +75% Cutoff). It's somewhat ambiguous if each of the 140 lay persons tested 1 sample, or if the sample count of 20 per concentration implies 20 unique samples tested across the 140 participants. Given "Each participant was provided with ... 1 blind labeled sample," it suggests 140 samples were tested in total across the lay users, with 20 samples falling into each defined concentration range.
  • Data Provenance: Not explicitly stated, but implies U.S. participants, likely prospective collection for the study.

• Test Set (Precision Study):

  • Sample Size: 9 concentration levels, tested 2 tests per day for 10 days per device lot, across 3 device lots. This equals 9 concentrations * 2 tests/day * 10 days * 3 lots = 540 individual tests.
  • Data Provenance: Samples were "prepared by spiking fentanyl in negative samples," meaning they were artificially created samples.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

For the Method Comparison Study and Lay-User Study, the ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an objective, gold-standard analytical chemistry method, not reliant on expert human interpretation. For the Precision Study, the samples were "prepared by spiking fentanyl in negative samples" and "confirmed by LC/MS," meaning the ground truth for concentration was analytically derived.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

For all performance studies detailed (Method Comparison, Precision, Lay-User), the "results" of the device were compared against an objective analytical ground truth (LC/MS confirmation of spiked or real sample concentrations), rather than human interpretation. Therefore, no multi-reader adjudication method was necessary or performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a qualitative chemical immunoassay, not an AI-based diagnostic image or data interpretation system. It does not involve human readers interpreting complex medical data with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Yes, in essence. The studies conducted (Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH, Method Comparison, Lay-User Study) all assessed the performance of the device itself (the "algorithm" in the context of an immunoassay) against established ground truth or reference standards. While "algorithm" might typically refer to software, here it refers to the intrinsic analytical process of the immunoassay device. The results are reported as the device's accuracy in detecting fentanyl.

7. Type of Ground Truth Used

• Clinical Samples (Method Comparison): LC/MS results. This is an analytical gold-standard method for precise quantification of substances in a sample.
• Spiked Samples (Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH): Prepared concentrations confirmed by LC/MS. This is a highly controlled, analytically derived ground truth.
• Lay-User Study: LC/MS results of the prepared and blinded samples.

8. Sample Size for the Training Set

• Sample Size: Not applicable.

This device is a lateral flow immunoassay. It is not an AI/machine learning device that requires a "training set" in the conventional sense of computational models learning from data. Its performance is based on the inherent chemical and immunological properties built into the device design.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Established: Not applicable.

As mentioned above, this is not an AI/ML device, so there is no training set or associated ground truth establishment process for a machine learning model. The "training" of such a device is in its chemical formulation and manufacturing process ensuring consistent and accurate reactivity.

Ask a specific question about this device