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510(k) Data Aggregation
(68 days)
The ACON TCA One Step Tricyclic Antidepressants Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are rapid chromatographic immunoassays for the qualitative detection of Tricyclic Antidepressants in human urine at a cut-off concentration of 1,000 ng/mL in reference to Nortriptyline. They are intended for Healthcare professionals including professionals at the point-of-care sites.
The ACON TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Tricyclic Antidepressant in a urine sample. The test is based on the principle of antigen-antibody immuncchemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Tricyclic Antidepressant in urine at a cut-off concentration of 1000 ng/mL for Nortriptyline. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Tricyclic Antidepressant at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control. a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ACON TCA One Step Tricyclic Antidepressant Test Strip and Device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical target format (e.g., "Positive Agreement > 90%"). However, it reports performance metrics against a predicate device and a reference method, implying these reported values demonstrate acceptable performance for substantial equivalence.
| Performance Metric (vs. Predicate Device: Status DSTM One Step Tricyclic Antidepressants Test) | ACON TCA Test Strip Performance | ACON TCA Test Device Performance |
|---|---|---|
| Positive Agreement (95% CI) | 95% (86% - 99%) | 95% (86% - 99%) |
| Negative Agreement (95% CI) | 100% (98% - 99%) | 100% (98% - 99%) |
| Overall Agreement (95% CI) | 99% (96% - 99%) | 99% (96% - 99%) |
| Performance Metric (vs. Reference Method: HPLC at 1,000 ng/mL cutoff) | ACON TCA Test Strip Performance | ACON TCA Test Device Performance |
|---|---|---|
| Agreement for Negative (Drug-free urine) | 100% (150/150) | 100% (150/150) |
| Agreement for Negative (<-25% cutoff) | 0% (0/17) - Incorrectly reported as "Negative", should be Positive | 0% (0/17) - Incorrectly reported as "Negative", should be Positive |
| Agreement for Negative (-25% cutoff to cutoff) | 0% (0/12) - Incorrectly reported as "Negative", should be Positive | 0% (0/12) - Incorrectly reported as "Negative", should be Positive |
| Agreement for Positive (Cutoff to +25% cutoff) | 100% (15/15) | 100% (15/15) |
| Agreement for Positive (>+25% cutoff) | 100% (20/20) | 100% (20/20) |
| % Agreement (Negative) | 89% (84% - 93%)* | 89% (84% - 93%)* |
| % Agreement (Positive) | >99% (90% - 99%)* | >99% (90% - 99%)* |
| Note: The tables for HPLC comparison in the original document seem to have a mixed interpretation of "Negative" and "Positive" agreement, particularly for the categories around the cutoff. The data presented indicates the device accurately identified true negatives (drug-free) and true positives (> +25% cutoff). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 226 clinical urine specimens.
- This included "over 10% of the samples with Antidepressants concentrations at -25% cut-off to +25% cut-off range."
- Data Provenance: The document does not explicitly state the country of origin. It mentions "clinical urine specimens," which implies human-derived data. The study is a "clinical evaluation," typically prospective in nature, as it compares new devices to existing methods. However, it doesn't explicitly state "retrospective" or "prospective."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method. The ground truth was established by comparison to the predicate device and High-Performance Liquid Chromatography (HPLC).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) device, which typically does not involve human readers interpreting results in the same way imaging AI does. The device produces a visual, qualitative result (colored line or no colored line).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance presented in the "ACON TCA One Step Tricyclic Antidepressant Test Strip versus HPLC" and "ACON TCA One Step Tricyclic Antidepressant Test Device versus HPLC" tables represents the standalone performance of the device. The device's output (presence/absence of a line) is directly compared to the reference standard (HPLC). There is no "human-in-the-loop" interpretation beyond observing the presence or absence of a line.
7. The Type of Ground Truth Used
The ground truth was established by two methods:
- Comparison to a legally marketed predicate device: Status DSTM One Step Tricyclic Antidepressants Test.
- Reference method: Customary High-Performance Liquid Chromatography (HPLC) analysis, which is an established laboratory method for drug quantification.
8. The Sample Size for the Training Set
There is no mention of a separate training set or its sample size. For these types of immunoassay devices, the development process might involve internal validation and optimization, but a distinct "training set" like in machine learning is not typically detailed in 510(k) submissions unless it's an AI-driven diagnostic.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed, there is no information on how its ground truth was established.
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