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The TECO Diagnostics URS-1G (Glucose Test) is intended for "Over the Counter use." The test is used, by lay people, for a qualitative determination of glucose in human urine. Urinary glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

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This is an FDA Premarket Notification (510k) Summary for a urine glucose test. Unfortunately, the provided document does not contain the detailed study information required to answer your questions comprehensively. It primarily concerns the FDA's substantial equivalence determination for the URS-1G (Glucose Test) and its intended use.

Here's what can be extracted and what information is missing based on your request:

Acceptance Criteria and Device Performance (Partial)

The document doesn't explicitly state "acceptance criteria" or provide a table of reported device performance in the way you've requested. However, for a diagnostic device like this, common performance metrics would typically include sensitivity, specificity, accuracy, linearity, and precision against a reference method. The approval as "substantially equivalent" implies these aspects were deemed adequate compared to a predicate device.

Missing Information:

Here's a breakdown of the information requested that is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This information is generally found in the detailed study report within the 510(k) submission, not in the FDA's determination letter or the Indications for Use statement.
2. Sample sizes used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are more common for imaging devices or those requiring subjective human interpretation. For a qualitative, "over-the-counter" urine glucose test strip, an MRMC study is highly unlikely. The performance would typically be evaluated against a reference laboratory method rather than human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: For a simple diagnostic test strip, the "algorithm" is the chemical reaction on the strip. Its standalone performance is its inherent performance without human interpretation error impacting the chemical reaction itself. The "over-the-counter" nature implies lay user interpretation, but the core performance data would be the strip's ability to detect glucose accurately. The document does not specify performance data.
7. The type of ground truth used: For a urinary glucose test, the ground truth would most likely be established by a quantitative laboratory method (e.g., hexokinase method, glucose oxidase method) on fresh urine samples. The document does not explicitly state this.
8. The sample size for the training set: This refers to machine learning algorithms. This device is a chemical test strip, not an AI/ML-driven device, so there is no "training set" in that context.
9. How the ground truth for the training set was established: As above, not applicable for this type of device.

In summary, the provided FDA communication is primarily an approval letter and an "Indications for Use" statement. It does not contain the detailed technical and scientific study data that would be required to answer most of your questions. To obtain such information, one would typically need access to the full 510(k) submission, which is generally not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

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