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This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal immunoglobulin production and the body's lack of ability to resist infectious agents.

Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for "Human IgG Subclass Liquid Reagent Kits," approving the device for marketing. It discusses regulatory information, classifications, and general controls, but it does not detail:

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

The "Indications for Use Statement" mentions that the kit is for "quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum," and that "Measurement of these immunoglobulins aids in the diagnosis of primary and secondary immunodeficiency diseases and the body's lack of ability to resist infectious agents." However, this is about the intended use, not the performance or validation study details.

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This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Subcrasses of these immunoglobulins aids in the diagnosis of reasurement of chobe inmancy-nd the body's lack of ability to resist infectious agents.

Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

This is a 510(k) summary, not a study report. Therefore, it does not contain the detailed information required to answer all the questions about acceptance criteria and study particulars. A 510(k) notification primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with acceptance criteria and performance data.

However, based on the provided text, I can extract the following limited information:

• Device Name: Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)
• Intended Use: Quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement aids in the diagnosis of primary and secondary immunodeficiency and the body's lack of ability to resist infectious agents.
• Predicate Device: Not explicitly named, but the submission claims "substantial equivalence" to legally marketed predicate devices.

The document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Information on a multi-reader multi-case (MRMC) comparative, human-in-the-loop, or standalone performance study.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study details based on the provided text.

Ask a specific question about this device

This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNI. Subcrasses if 2, 3 and innoglobulins aids in the diagnosis of Measurement of chebe immandy ond the body's lack of ability to resist infectious agents.

Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, "Human IgG Subclass Liquid Reagent Kits." It does not contain any information about acceptance criteria for a device performance, a study to prove these criteria were met, or any details related to AI/algorithm performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as they would be presented for an AI-powered diagnostic device.

Ask a specific question about this device