(284 days)
The Combi Scan 100 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
The Combi Scan 100 is a small urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
The provided documentation describes the Combi Scan 100, an automated urine analyzer, and its 510(k) submission for substantial equivalence to a predicate device, the Clinitek 50. However, the document does not contain specific acceptance criteria, a detailed study report demonstrating performance against such criteria, or the methodology used for establishing ground truth or expert adjudication.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
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Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided text. The document states that "Analyticon has submitted Information that shows the substantial equivalence to the predicative device," but it does not detail the specific performance metrics or acceptance criteria used to establish this equivalence, nor does it present the Combi Scan 100's performance against them in a table. -
Sample size used for the test set and the data provenance:
This information is not available in the provided text. The submission summary does not include details on the sample size used for any testing or the provenance of the data (e.g., country of origin, retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text. There is no mention of expert involvement in establishing ground truth for any test sets. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided text. No adjudication method is described. -
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 information is not applicable/not available. The Combi Scan 100 is described as an "Automated Urine Analyzer" that measures urine test strips. It does not appear to be an AI-assisted device designed to improve human reader performance in a diagnostic setting. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this device as described. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not explicitly detailed, but the nature of the device suggests standalone performance: "The instrument measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." This implies the device provides direct results without human interpretation of the color changes. Comparison is made to another automated analyzer, the Clinitek 50. The summary itself is focused on device properties and functional equivalence rather than detailed performance studies. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided text. The document does not specify how the ground truth for any performance evaluation was established. For urine analyzers, ground truth typically involves reference laboratory methods or established manual interpretations of test strips. -
The sample size for the training set:
This information is not available in the provided text. There is no mention of a "training set" or its size, as this type of device (an automated urine analyzer) typically relies on predefined optical or chemical reaction parameters rather than a machine learning training paradigm. -
How the ground truth for the training set was established:
This information is not applicable/not available for the reasons stated above (no mention of a training set or machine learning).
§ 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.