(214 days)
The URYXXON® 200 is a portable reflectance photometer that instrumentally measures the reflectance on a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The product is intended for use on urine specimens for the semi-quantitative determination of blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes. The test results are used in the evaluation of diabetes, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract. The test provided on Macherey-Nagel Reagent Strips for the determination of specific gravity, leucocytes, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.
The URYXXON® 200 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips for the following analytes: blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes.
The provided 510(k) summary for the URYXXON® 200 Urine Analyzer does not contain specific acceptance criteria or detailed study results demonstrating device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device, the CLINITEK® 50 Urine Analyzer.
Therefore, many of the requested sections regarding acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text. The document refers to "results of clinical testing that demonstrate the substantial equivalence," but these results are not detailed in the summary.
Below is a response based on the available information in the provided text.
Acceptance Criteria and Device Performance
Based on the provided 510(k) summary, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) for each analyte are not explicitly stated. The summary mentions "performance specifications" were presented to the FDA to demonstrate substantial equivalence, but these specifications themselves are not detailed.
The general acceptance criterion implied is that the URYXXON® 200 performs substantially equivalently to the predicate device, the CLINITEK® 50 Urine Analyzer, for the listed analytes.
Table of Acceptance Criteria and Reported Device Performance:
| Analyte | Acceptance Criteria (Not Explicitly Stated for this device in the Summary) | Reported Device Performance (Not Explicitly Stated for this device in the Summary) |
|---|---|---|
| Blood | Implied: Substantially equivalent to predicate | N/A |
| Urobilinogen | Implied: Substantially equivalent to predicate | N/A |
| Bilirubin | Implied: Substantially equivalent to predicate | N/A |
| Protein | Implied: Substantially equivalent to predicate | N/A |
| Nitrite | Implied: Substantially equivalent to predicate | N/A |
| Ketones | Implied: Substantially equivalent to predicate | N/A |
| Ascorbic Acid | N/A (unique to this device compared to predicate) | N/A |
| Glucose | Implied: Substantially equivalent to predicate | N/A |
| pH | Implied: Substantially equivalent to predicate | N/A |
| Specific Gravity | Implied: Substantially equivalent to predicate | N/A |
| Leucocytes | Implied: Substantially equivalent to predicate | N/A |
Explanation: The document states, "MACHEREY-NAGEL has presented information of the technological principles, performance specifications, indications for use and results of clinical testing that demonstrate the substantial equivalence of the URYXXON® 200 to the predicate devices." However, these "performance specifications" and "results of clinical testing" are not included within the summary itself. Therefore, specific numerical performance figures or explicit acceptance criteria for the URYXXON® 200 cannot be extracted.
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only mentions "results of clinical testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The summary does not provide details on how ground truth was established for the clinical testing mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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 is a device for instrumental measurement (a reflectance photometer for automated reading of urine test strips), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The URYXXON® 200 is inherently a "standalone" device in the sense that it performs the measurement automatically without human interpretation of the strips. The summary implies the device's performance was evaluated independently to demonstrate equivalence to the predicate. However, detailed results of this standalone performance are not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the provided summary. For urine chemistry analyzers, ground truth often involves comparison against a reference method (e.g., laboratory wet chemistry or a highly precise manual method) or expert visual interpretation, but the document does not specify.
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The sample size for the training set:
- The URYXXON® 200 is a reflectance photometer, not a machine learning or AI algorithm in the contemporary sense that would require a "training set" for model development. Its calibration and measurement principles are based on established photometric methods. Therefore, the concept of a "training set" in the context of AI does not directly apply here.
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How the ground truth for the training set was established:
- As explained above, a "training set" as understood in AI/ML is not applicable to this type of device. Calibration of the instrument would be part of its manufacturing and quality control process, established against known standards.
§ 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.