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The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

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This document is a 510(k) premarket notification decision letter from the FDA for a medical device. It does not contain information about acceptance criteria or specific study details that would allow me to populate the requested table and answer the detailed questions about device performance and study design.

The document primarily states that the device, "Rheumatoid Factor (RF) Kit For Use On SPAPLUS®," is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot fulfill the request based on the provided text.

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This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

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The provided text is a 510(k) premarket notification document for a medical device. It is a regulatory approval, not a scientific study document. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Specifically, the document:

• Identifies the device: Human alpha-2-Macroglobulin kit for use on SPAPLUS.
• States its intended use: Quantitative in vitro measurement of alpha-2-Macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders.
• Declares substantial equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, nor data provenance.
3. Information on experts or ground truth for the test set.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific document. The information you're asking for would typically be found in a separate study report or technical documentation submitted as part of the 510(k) application, but it is not present in the FDA's decision letter itself.

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The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.

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This document is a 510(k) premarket notification from the FDA, indicating that the device, Freelite® Human Lambda Free Kit, has been deemed substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed studies, acceptance criteria, or performance data as it's a notification of substantial equivalence, not a detailed clinical trial report or a comprehensive technical specification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's what can be inferred or stated based on the document's content:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". It does not include specific performance metrics or acceptance criteria for the Freelite® Human Lambda Free Kit itself. Substantial equivalence is often based on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily by meeting pre-defined quantitative acceptance criteria in this document.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document does not describe any specific test set data or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not provided. No information about ground truth establishment or experts is included.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided. There is no mention of an adjudication method as no test set details are given.

5. 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:

   • Not applicable / Not provided. This device is an "Immunoglobulin (light chain specific) immunological test system" intended for the quantitation of free light chains in serum and urine. It is an in vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not explicitly stated, but implicitly "yes" as an IVD. As an in vitro diagnostic kit, the device itself performs the "algorithm" (i.e., the chemical and immunological reactions and detection) to quantify free light chains. Its performance is measured directly, often against a reference method or known concentrations, rather than being part of a human-in-the-loop system in the way AI algorithms are evaluated. However, the document does not provide details of such standalone performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not provided. The document does not specify how ground truth was established for any studies that may have been submitted for the 510(k). For an IVD, ground truth would typically involve reference methods, confirmed clinical diagnoses, or established standards for protein quantification.

8. The sample size for the training set:

   • Not applicable / Not provided. This is an in vitro diagnostic kit, not a machine learning or AI algorithm that typically uses a "training set" in the computational sense. If any form of 'training' or calibration was done for the assay, the sample size or details are not mentioned.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. See explanation for #8.

In summary, the provided FDA 510(k) clearance letter acknowledges the submission and declares substantial equivalence. It is a regulatory document and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. These details would typically be found in the manufacturer's 510(k) submission itself, which is not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

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The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

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The provided document is a 510(k) clearance letter from the FDA for the "Human alpha-1 Antitrypsin Kit for use on SPAPLUS". It states that the device is substantially equivalent to a predicate device. However, it does not contain any information about the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information based on the input document.

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Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.

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This document is a 510(k) clearance letter from the FDA for "The Binding Site Human Albumin CSF kit for use on SPAplus". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain a detailed study report with acceptance criteria and device performance as described in your request. It's a regulatory approval, not a scientific publication presenting study data.

Therefore, I cannot provide the specific information requested about acceptance criteria, sample sizes, ground truth establishment, or expert qualifications based on this document. These details would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.

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The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided text does not contain the information required to answer your request. The document describes an FDA 510(k) clearance letter for a "Human Ceruloplasmin Kit for use on SPAPLUS," outlining its intended use and regulatory classifications. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Specifically, the document lacks:

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 used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Human IgA CSF Kit for Use on SPAplus". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, based on its intended use for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyzer to aid in assessing the body's ability to resist infectious disease.

Therefore, I cannot provide the requested information from the given text.

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This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

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The provided document is an FDA 510(k) clearance letter for an in vitro diagnostic device, the "Human C1 Inactivator Kit for use on SPAPLUS." It does not contain any information about the acceptance criteria or study details for proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which is a separate document).

The letter primarily confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulation name, regulatory class, and product codes. It also outlines responsibilities of the manufacturer regarding general controls, labeling, and reporting.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Details about experts for ground truth establishment or adjudication methods.
• Information on MRMC studies or standalone algorithm performance.
• The type or establishment method of ground truth.

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This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.

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The provided text is related to a 510(k) premarket notification for a medical device called "Human C3c Kit for use on SPAPLUSTM". It grants substantial equivalence to legally marketed predicate devices, but it does not contain a detailed study report with acceptance criteria, performance data, or information about sample sizes, ground truth establishment, or expert involvement as requested.

The document is an FDA clearance letter and an "Indications for Use" statement. It does not describe a performance study in the way a scientific paper or a detailed clinical trial report would.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving the device meets those criteria based only on the provided text. The text confirms the device's intended use and regulatory status but does not describe the specific performance study that led to its clearance.

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