(408 days)
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information. Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
The device's performance was proven through a combination of laboratory and clinical studies demonstrating its substantial equivalence to the predicate device, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state numerical acceptance criteria (e.g., specific sensitivity or specificity thresholds) or quantitative device performance metrics (e.g., exact percentages for accuracy, sensitivity, or specificity). Instead, the studies aim to demonstrate that the Teco Diagnostics UTI Test Strips "run well and met all required performance characteristics" and that lay users could "obtain comparable testing data compared to those obtained by the professionals" and to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | The device should accurately detect the presence of Nitrite and Leukocytes to aid in UTI screening. | Laboratory studies (sensitivity studies) indicate the device performs satisfactorily. |
| Reproducibility | Consistent results should be obtained when the test is repeated under the same conditions. | Laboratory studies (reproducibility study) indicate the device performs satisfactorily. |
| Interference | The device should not be significantly affected by interfering substances typically found in urine. | Laboratory studies (interference studies) indicate the device performs satisfactorily. |
| Stability | The device should maintain its performance over its shelf-life and under various storage conditions. | Laboratory studies (stress study and stability studies) indicate the device performs satisfactorily. |
| Clinical Accuracy | Lay users should be able to obtain clinically comparable and correct results when using the device compared to professional users and the predicate device. | Clinical study results indicated that inexperienced lay users were able to obtain comparable testing data compared to those obtained by professionals when using Teco Diagnostics UTI Test Strips and the Bayer Multistix 10 SG Reagent Strips for Urinalysis. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the clinical test set or the laboratory test set.
- Data Provenance: The clinical studies were conducted at "Point of Care sites" and "with lay persons," implying the data was collected from human urine samples. The document does not specify the country of origin, but given the submitter is based in Anaheim, CA, USA, and the predicate device is from Elkhart, IN, USA, it's highly probable the data is from the US. The studies are prospective in nature, as they involve testing the device on samples collected for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that clinical studies compared results from "inexperienced lay users" to "professionals." It does not specify the exact number of professionals or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of urinalysis, these professionals would likely be trained medical technicians, nurses, or other healthcare providers familiar with performing and interpreting urine reagent strip tests in a clinical setting.
4. Adjudication method for the test set
The document does not mention a specific adjudication method like "2+1" or "3+1." It implies a direct comparison, stating "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This suggests that the professionals' readings or a more definitive lab result for the same sample served as the benchmark against which lay users' readings were compared.
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
- MRMC Study: A type of comparative effectiveness study was done comparing the performance of lay users and professionals using the Teco Diagnostics UTI Test Strips, and against the predicate device. This aligns with the spirit of an MRMC study in that it assesses different "readers" (lay vs. professional) on the same "cases" (urine samples).
- Effect Size/AI Assistance: This study does not involve AI assistance. The comparison is between human readers (lay vs. professional) and between two different manual test strips. Therefore, there is no effect size related to AI improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a manual urine reagent strip, requiring human-in-the-loop performance (visual interpretation of color changes).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study was based on the results obtained by "professionals" using either the Teco Diagnostics UTI Test Strips or the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis. This can be considered a form of expert reference or standard device comparison, where the predicate device's results and professional interpretation of the test strips serve as the benchmark. It is not explicitly stated if further confirmatory tests (e.g., urine culture for UTI) were used as the ultimate ground truth, but the focus is on the performance of the test strips themselves in aiding screening.
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. For medical devices, particularly those without complex algorithms that "learn," the concept of a distinct training set (as in machine learning) may not directly apply in the same way. The development and optimization of the test strip's chemical reagents and color chart would be an iterative process, but not typically referred to as "training" in the context of sample sizes in regulatory submissions like this.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable here. The development of the test strip's performance (e.g., sensitivity, reproducibility, stability) would have been established through internal laboratory studies where known concentrations of analytes and controlled conditions were used to assess and optimize the reagents' performance. This would involve established analytical methods as a form of reference.
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.