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For in vitro diagnostic use only. The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

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This document does not contain the information required to describe the acceptance criteria, device performance, or details of a study proving the device meets acceptance criteria.

The provided text is a 510(k) clearance letter from the FDA for a device called "Drew Scientific, Glycated Hemoglobin Five Level Linearity Kit." This letter grants marketing authorization based on a finding of "substantial equivalence" to a predicate device. It is not a study report or a detailed technical submission.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, the document does not provide any of the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance notice, not a performance study.

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For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system.

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This document is a 510(k) clearance letter from the FDA for a Glycated Haemoglobin Two Level Calibrator Kit. It does not contain detailed information about acceptance criteria or specific study results showing device performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. To find the information you're looking for, you would typically need to consult the full 510(k) submission or the device's labeling/user manual, which would include performance studies and validation data.

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Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.
prescription use

Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)

The provided text is a 510(k) clearance letter from the FDA for a blood collection tube (DS30 Hcy Blood Collection Tubes). It does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML-based medical devices or comparative effectiveness studies.

Therefore, I cannot fulfill the request as the provided document focuses on regulatory clearance for a blood specimen collection device and does not detail a study involving the criteria mentioned.

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In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.

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I am sorry, but the provided text from the FDA document (K982003) is a 510(k) clearance letter for a diagnostic device (DS30 Hcy Homocysteine Assay Kit), not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, the document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. These details would typically be found in the device's premarket submission or a separate validation study report, not in the clearance letter itself.

The document only specifies:

• Device Name: DS30 Hcy Homocysteine Assay Kit
• Intended Use: In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.

Without a detailed study report, I cannot provide the requested information.

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