(21 days)
Wondfo Phencyclidine Urine Test and Wondfo Phencyclidine Urine are intended for the qualitative determination of Phencyclidine and Notriptyline (target analytes)at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 25ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.
Wondfo Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 ng/mL. The test is available in a dip card format. It is intended for prescription use and over the counter use.
Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be similar to the legally marketed predicates.
However, the core performance aspect for these qualitative urine tests is their ability to correctly identify the presence or absence of the target analytes at specific cut-off concentrations. This is implicitly the acceptance criterion: accurate qualitative detection at the specified cut-off concentrations.
| Specific Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Qualitative determination of Phencyclidine at 25 ng/mL cutoff. | The device is an immunochromatographic assay for qualitative determination of Phencyclidine at this cutoff. Its performance is considered "similar... and equivalent" to the predicate. |
| Qualitative determination of Nortriptyline at 1000 ng/mL cutoff. | The device is an immunochromatographic assay for qualitative determination of Nortriptyline at this cutoff. Its performance is considered "similar... and equivalent" to the predicate. |
| Consistent results with predicate devices regarding positive/negative detection around cutoff values. | The overall claim is "similar technological characteristics and performance to the predicate and are equivalent." No specific numerical performance data (e.g., sensitivity, specificity, accuracy) is provided in this summary document. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not contain any information regarding:
- The sample size used for any test set or clinical study.
- The country of origin of any data.
- Whether the data was retrospective or prospective.
This type of detail is typically found in a clinical study report or a more comprehensive performance data section of a 510(k), which is not fully included here. The summary focuses on the comparative features and the claim of substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not contain any information regarding:
- The number of experts used to establish ground truth.
- The qualifications of any such experts.
4. Adjudication Method for the Test Set:
The document does not contain any information regarding any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported in this document. The device is an in-vitro diagnostic test for qualitative determination of analytes in urine, not an imaging device requiring human reader interpretation in the same way. The comparison is made against predicate devices, not against human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance assessment of the device (without explicit "human-in-the-loop" assistance for interpretation beyond reading the visual result) is implied. The device itself is an immunochromatographic assay that produces a visual result (line/no line) indicating positive or negative. The "study" mentioned is the comparison of the device's characteristics and performance to predicate devices to demonstrate substantial equivalence. The document states its indications for use are for "healthcare professional use and over the counter use," implying that lay users and professionals interpret the inherent results of the test.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for performance evaluation. However, for drug screens, the preferred confirmatory method is often mentioned:
- For Phencyclidine: GC/MS (Gas Chromatography/Mass Spectrometry) is the preferred confirmatory method.
- For Notriptyline: GC/MS or HPLC (High-Performance Liquid Chromatography) is the preferred confirmatory method.
These lab-based analytical methods are considered the "gold standard" for establishing ground truth regarding the presence and concentration of drugs in urine.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. For an immunochromatographic assay, the development process involves reagent selection, optimization, and characterization, rather than "training" an AI model with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established:
As there's no mention of a "training set" in the context of an AI model, this question is not applicable. For the development and validation of the immunoassay itself, highly characterized samples (e.g., spiked urine samples with known concentrations of analytes, or clinical samples confirmed by GC/MS/HPLC) would typically be used to establish performance characteristics, but specific details are not provided in this summary.
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).