(118 days)
This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff level of 1000 ng/ml in human urine. It is for health care professional use only.
It is for health care professional, in-vitro diagnostic use only.
This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only.
Instant-View™ TCA Urine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-TCA antibodies; 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The Test line is coated with TCA- BSA, and the Control line is coated with goat anti-mouse IgG antibody.
Here's a breakdown of the acceptance criteria and study information for the Instant-View™ TCA Urine Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy - Negative | High agreement with GC/MS for negative samples | 96.7% (58/60) agreement |
| Accuracy - Positive | High agreement with GC/MS for positive samples | 100% (20/20) agreement |
| Accuracy - Overall | High overall agreement with GC/MS | 97.5% overall accuracy |
| Reproducibility | High agreement across different testing sites and operators | 99% agreement across four sites |
| Specificity - Related Compounds | Positive response to TCA-related compounds at or above cutoff | Positive responses to Amitriptyline, Desipramine, Imipramine, Nortriptyline, Nordoxepine at 1000 ng/ml; Cyclobenzaprine, Protriptyline, Trimipramine > 1500 ng/ml; Doxepine, Clomipramine > 3000 ng/ml. |
| Specificity - Unrelated Compounds | No significant interference from structurally unrelated compounds | No significant interference observed with structurally unrelated compounds at 1 mg/ml. |
Note: The acceptance criteria are implicit based on the reported performance. The document doesn't explicitly state quantitative thresholds the device needed to meet, but rather presents the results as demonstrating "accuracy," "reproducibility," and "specificity."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Test Set: 80 clinical urine samples.
- Data Provenance: The document states "clinical urine samples," which implies human-derived samples. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the accuracy study was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a chemical method, not human expert interpretation. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to imaging or diagnostic interpretation by trained professionals does not directly apply here. GC/MS itself is considered a gold standard for drug quantification.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by GC/MS, a definitive chemical analysis method, not by human adjudication of potentially subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is for an in vitro diagnostic device (immunoassay) for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the accuracy and reproducibility studies described are standalone performance evaluations of the device itself (the immunoassay) without human interpretation being part of the primary outcome measure. While humans operate the test and interpret its visual output (lines on a strip), the core performance metrics are determined by how accurately the device differentiates between samples at the cutoff compared to the GC/MS reference.
7. Type of Ground Truth Used
The ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly specific and quantitative analytical method, often considered a definitive or "gold standard" for confirming the presence and concentration of drugs.
8. Sample Size for the Training Set
No information is provided regarding a "training set." This device is a lateral flow immunoassay, not a machine learning or AI algorithm that typically requires a distinct training set. The performance is based on its inherent biochemical reactivity and design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of a training set for this type of device.
§ 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).