(120 days)
The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine.
The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.
Plastic strips with reagent pads which provide a color change when exposed to urine.
The AimStick® Urine Reagent Strips are plastic strips to which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged with a drying agent in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
Here's a breakdown of the acceptance criteria and study information for the AimStick® Urine Reagent Strips, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, or agreement percentages. Instead, the acceptance criterion is implied as "substantial equivalence" to the predicate device (Bayer MultiStix® 10SG). The reported device performance is described as meeting this criterion through a comparative clinical trial.
| Analyte (Test Parameter) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Glucose | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Bilirubin | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Ketone | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Specific Gravity | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Blood | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| pH | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Protein | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Urobilinogen | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Nitrite | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Leukocytes | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 196 urine samples.
- Data Provenance: The text does not explicitly state the country of origin. It describes the study as a "clinical trial" comparing two devices, which implies prospective data collection for the purpose of the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts used or their qualifications for establishing ground truth. The study design described is a direct comparison between the AimStick® and the predicate device (Bayer MultiStix® 10SG), implying the predicate device's results served as the reference for comparison, rather than an independent expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method. The study design directly compares the results of the AimStick® with the Bayer MultiStix® 10SG. This suggests a direct comparison method rather than an independent adjudication for establishing truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a visually read diagnostic strip (without AI) and the study described is a direct comparison between two test strip products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) study was not done. This device is a manual, visually interpreted test strip, not an algorithm-based or AI-driven system. The "performance" is based on human visual interpretation of the color changes on the strip.
7. The Type of Ground Truth Used
The ground truth for the comparison was essentially the results obtained from the legally marketed predicate device, Bayer MultiStix® 10SG. The study aimed to demonstrate that the AimStick® results align with those of the established predicate device.
8. The Sample Size for the Training Set
The text does not mention a training set because this is a diagnostic device that relies on chemical reactions and visual interpretation, not an AI or machine learning model that would require a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set mentioned or implied for this type of device.
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(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.