(65 days)
Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test are intended for the qualitative determination of Benzoylecgonine, D(+)-Methamphetamine (target analyte) at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Wondfo Cocaine Urine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a cutoff concentration of 300ng/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 Methamphetamine Urine Test is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 1000 ng/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.
Immunochromatograph assay for Cocaine and Methamphetamine Urine Test using a lateral flow, one step system for the qualitative detection of Benzoylecgonine, D(+)-Methamphetamine (target analyte) 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.
This document is a 510(k) premarket notification for the "Wondfo Cocaine Urine Test" and "Wondfo Methamphetamine Urine Test." While it describes the intended use and summarizes a comparison to a predicate device, it does not contain a detailed study report with acceptance criteria and specific performance data that directly addresses the prompt's request for a study proving the device meets acceptance criteria.
The provided text focuses on demonstrating substantial equivalence to a legally marketed predicate device (Acon Laboratories, Inc. One Step Drug Screen Test, K020771) based on similar technological characteristics and intended use. Performance data is not elaborated upon in this summary section, which is typical for the summary portion of a 510(k) submission.
Therefore, I cannot provide all the requested information as it is not present in the given text.
Here's what can be extracted based on the provided text, and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) for clinical studies, nor does it report detailed performance results from such studies. Instead, it focuses on demonstrating equivalence to the predicate device.
The closest to "performance" stated is the "Cut Off Values" for the qualitative determination of the substances:
| Substance | Cut-Off Value |
|---|---|
| Cocaine | 300 ng/ml |
| Methamphetamine | 1000 ng/ml |
The document states, "The Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test have similar technological characteristics and performance to the predicate and are equivalent." However, it does not provide the specific performance data proving this equivalence in the form of a study.
Missing Information (Not Available in the Provided Text)
The following information is not available in the provided 510(k) summary:
- 1. A table of acceptance criteria and the reported device performance: While cut-off values are given, specific performance metrics (e.g., sensitivity, specificity, PPV, NPV) and acceptance thresholds for those metrics are not provided.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample size or data collection are given.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Ground Truth Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: This is an immunoassay, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as described above. The device performs a qualitative determination.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it states "GC/MS is the preferred confirmatory method," the method used to establish ground truth for any specific study dataset is not described.
- 8. The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI algorithm, as this is a biochemical assay).
- 9. How the ground truth for the training set was established: Not mentioned.
Summary of Device and Study Context (based on available info):
This document describes a "Wondfo Cocaine Urine Test" and "Wondfo Methamphetamine Urine Test" as immunochromatographic assays for the qualitative detection of Benzoylecgonine and D(+)-Methamphetamine in human urine, respectively. The tests are intended for healthcare professional use and over-the-counter use in dip card and cup formats. The 510(k) submission aims to establish substantial equivalence to a predicate device (Acon Laboratories, Inc. One Step Drug Screen Test, K020771) by highlighting similar assay principle, methodology, test type, results, specimen type, and cut-off values. The preferred confirmatory method for positive results is GC/MS. The document does not provide the detailed study information as requested.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).