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Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.

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The document provided is a 510(k) clearance letter from the FDA for "Urinalysis Reagent Strips (10 Parameters)". This type of document assesses substantial equivalence to a predicate device, rather than detailed performance reports or clinical study results as would be found in a Premarket Approval (PMA) application. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment is not available in this document.

The primary function of a 510(k) notification is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This typically involves submitting information on design, materials, chemical composition, energy source, manufacturing process, and intended use, along with performance data demonstrating equivalence to the predicate device. However, the FDA letter itself does not contain the detailed performance data or study methodology that would typically be included in a scientific study report.

Here's a breakdown of why each requested piece of information cannot be provided based on the given text:

• 1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the study report itself. It states that the device is "substantially equivalent" but does not provide specific performance metrics or acceptance criteria tables.
• 2. Sample size used for the test set and the data provenance: Not present in this regulatory clearance letter. The original 510(k) submission would have contained this information.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
• 4. Adjudication method for the test set: Not present.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a device like urinalysis reagent strips, which are not typically "read" by multiple human readers in the same way as, for example, medical images for diagnosis. Even if a comparative study was done to demonstrate equivalence to the predicate device, details are not in this letter.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are reagent strips that produce a visual color change interpreted by a human, not an algorithm.
• 7. The type of ground truth used: Not present. For a diagnostic device like reagent strips, ground truth would likely involve more definitive laboratory methods (e.g., standard chemical analysis) to confirm the presence and concentration of the analytes.
• 8. The sample size for the training set: Not present.
• 9. How the ground truth for the training set was established: Not present.

To obtain the detailed study information, one would typically need to refer to the original 510(k) submission documentation filed with the FDA, which is a much more extensive technical package than the clearance letter provided.

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One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.

One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.

The provided text describes an FDA 510(k) clearance letter for a device called "One-Step Midstream Style hCG Pregnancy Test." However, it does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a performance study.

The document is a regulatory approval letter and focuses on the substantial equivalence of the device to a legally marketed predicate, allowing it to be marketed. It does not include the technical details of device performance testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. To answer your questions, I would need a different document, such as a study report, a technical file, or a summary of safety and effectiveness from the 510(k) submission, which typically contains this kind of information.

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MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Ministrip / Serum and Urine Combo HCG Test". This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed presentation of performance data or acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a scientific study report.

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PS - UNIT CASSETTE/ Serum and Urine Combo HCG test is a qualitative, two ne and the blogs as accesses test kit for rapid determination of hCG concect to PS - UNT CASSETTE/ Serum and Urine Combo HCG test is a qualification sites sandwich images ay test kit for rapid determination of hCG conceration of the same begine for esty sites sandwich immunoassy test kit for rapid determination of new to in both serum and wine for early detection of pregnancy. This test kit is used to in both serum and secur in both serum and urine for early detection of progently of the your by obtain a visual and qualitative result and is for clinical lab used.

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The provided text is a 510(k) premarket notification letter from the FDA for a device called "PS-UNIT CASSETTE/Serum and Urine Combo HCG Test" (later referred to as "One Step Serum / urine Combo HCG Cassette Test"). It does not contain information about acceptance criteria, device performance, or a study proving its conformance to such criteria. The letter primarily confirms that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device