(334 days)
Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine
Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.
The urine test strips can be used for the determination of the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated:
Disorders of the carbohydrate metabolism (diabetes)
Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis)
Illness of liver and haemolytic disorders.
The provided text is a 510(k) summary for the Combi-Screen Urine Test Strips. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might for a novel diagnostic device.
Therefore, the information available is limited regarding explicit acceptance criteria and a structured study proving those criteria are met for the new device. The submission primarily relies on comparison to the predicate device and a general statement about accuracy.
Based on the provided text, here's what can be extracted:
Acceptance Criteria and Device Performance
The submission does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity/specificity thresholds, agreement percentages with a gold standard) for each analyte for the Combi-Screen Urine Test Strips. Instead, it relies on demonstrating equivalence to the predicate device and the general statement that "They did not observe any false-negative or false-positive results." This implies that the 'acceptance criteria' are implicitly that the new device performs at least as well as the predicate device and other commercially available strips, without significant errors.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Performance equal to or better than the predicate device (Medi-Test Combi 11) and other market urine test strips (Roche, Dade-Behring, Bayer, Macherey-Nagel); no false-negative or false-positive results. | "The results of the accuracy study show that the test strips Combi-Screen have got the equal properties in principle like the test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey-Nagel. They did not observe any false-negative or false-positive results." |
| Indication for Use | Same as predicate device. | Same (Model 10SL does not have the Ascorbic Acid test). |
| Method | Dip in urine, check against color chart (same as predicate). | Same. |
| Time | 60 seconds (same as predicate). | Same. |
Additional Information (Based on provided text):
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Sample size used for the test set and the data provenance: The document does not specify the sample size for the test set. The data provenance is not explicitly mentioned (e.g., country of origin), and it's unclear if the study was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
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Adjudication method for the test set: This information is not provided in the document.
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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 device is a manual urine test strip, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a manual urine test strip that relies on human visual interpretation of color changes. It is not an algorithm-only device. "Standalone" performance in this context would refer to the strip's chemical reaction accuracy rather than an algorithm's.
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The type of ground truth used: The document states "accuracy study" and comparison to "test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey-Nagel." This implies that the ground truth was likely established by comparing the results of the Combi-Screen strips against established, perhaps laboratory-based, methods or other gold-standard urine analysis methods (though not explicitly stated as pathology or outcomes data). The phrase "They did not observe any false-negative or false-positive results" suggests a comparison against known positive and negative samples, or against reference methods.
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The sample size for the training set: The document does not specify a training set as this is not an AI/machine learning device. The "accuracy study" would typically involve a test set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.