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Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.

This document describes the Tina-quant Apolipoprotein A-1 ver.2 assay and its equivalence to a predicate device, but it does not detail a study with specific acceptance criteria that the device had to meet and prove. Instead, it describes a "substantial equivalence" comparison to an existing, legally marketed device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test set, training set details) are not applicable or cannot be extracted from the provided text, as this type of information is typically associated with studies demonstrating performance against a defined statistical endpoint, not substantial equivalence.

Here's an analysis based on the provided text, focusing on the available information:

Description of Acceptance Criteria and the Study:

The "study" described in the provided text is a substantial equivalence comparison between the Tina-quant Apolipoprotein A-1 ver.2 assay and a predicate device (Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay, K860894). The acceptance criteria for substantial equivalence are implicitly that the new device performs comparably to the predicate device across various characteristics, demonstrating similar safety and effectiveness.

The comparison focuses on:

• Intended Use and Indications for Use: Ensuring they are the same or very similar.
• Assay Protocol: Both are immunoturbidometric.
• Traceability/Standardization: The new device is standardized to IFCC reference preparation SP1-01.
• Calibration Interval: Similar.
• Performance Characteristics: Comparing precision, method comparison, hook effect, analytical sensitivity, and limitations.

The device meets the acceptance criteria by demonstrating performance characteristics that are comparable to or better than the predicate device, or within acceptable clinical ranges where direct comparison might not be feasible (e.g., analytical sensitivity).

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance of the predicate device, and the "reported device performance" is how the new device compares. No explicit numerical acceptance criteria (e.g., "CV must be

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The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and related diseases. FOR IN VITRO DIAGNOSTIC USE.

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The provided text is a 510(k) clearance letter from the FDA for a device named "K-ASSAY Apo B." This document primarily grants substantial equivalence and does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such detailed information is typically found in the 510(k) summary, which is a separate document.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• No Acceptance Criteria: The document does not specify any performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
• No Reported Device Performance: While the device is cleared for "quantitative determination of Apo B," the document does not contain numerical performance data such as assay precision, accuracy, linearity, or comparison with a reference method.
• No Study Details: There is no mention of the type of study conducted (e.g., prospective, retrospective), sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• No Ground Truth Information: The document does not describe how ground truth was established for development or testing sets.

The core of this document is the FDA's regulatory decision, not a scientific report of a device's performance characteristics.

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The K-ASSAY Apo Al Assay is intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FOR IN VITRO DIAGNOSTIC USE.

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This FDA 510(k) clearance letter (K993345) for the K-ASSAY Apo AI Assay primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary.

Specifically, the document does NOT provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for establishing ground truth.
4. Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

The letter states the device is "intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay" and that "Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This describes the intended use and clinical utility, but not performance metrics or study details.

To obtain the requested information, one would typically need to consult the complete 510(k) submission summary, which sometimes contains a more detailed description of the analytical and clinical studies performed to support the substantial equivalence claim. This particular clearance letter is a high-level official communication, not a scientific publication detailing study methodology and results.

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For in vitro quantitative determination Apolipoprotein A-1 in serum and plasma.

Apolipoprotein A-1 measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein A-1 in serum and plasma for use on the INTEGRA family of analyzers.

This 510(k) summary describes a device that is substantially equivalent to a previously marketed device, rather than providing independent acceptance criteria and a study proving the device meets those criteria. The submission focuses on demonstrating the similarities between the modified device and its predicate, implying that if the predicate device met acceptance criteria, the modified device, being similar, also meets them.

Therefore, many of the requested sections (acceptance criteria, device performance values, sample sizes, expert qualifications, adjudication, MRMC studies, standalone studies, ground truth types for test and training sets) cannot be directly extracted as they are not explicitly stated for the modified device in this document. The document argues for substantial equivalence primarily on the basis of identical intended use, indications for use, methodology, instrument, measuring range, and formulation.

However, I can extract the information provided regarding the similarities and the study supporting the substantial equivalence claim.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission, K990594, focuses on demonstrating substantial equivalence to a previously marketed predicate device (Roche INTEGRA Reagent Cassette for Apolipoprotein A-1, K954992) rather than establishing new, specific acceptance criteria for the modified device and then conducting a study to prove it meets them. The "study" here is a comparison demonstrating that the modified device is fundamentally the same as its predicate in key performance and design aspects.

The key argument is that because the predicate device was already deemed safe and effective, and the modified device is substantially equivalent to the predicate, the modified device also meets the necessary safety and effectiveness requirements.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a substantial equivalence submission, it does not define new acceptance criteria for the modified device, nor does it provide a new performance study with specific performance values against new acceptance criteria. Instead, it highlights the similarities between the modified device and its predicate, implying that the predicate's established performance serves as the benchmark.

Note: The "reported device performance" here is the design and functional specification of the modified device, which is presented as identical to the predicate device. Specific numerical performance data (e.g., accuracy, precision, linearity) for the modified device itself are stated as being "incorporated into the draft labeling in Section V of this submission," but are not provided in this 510(k) summary itself. The core of the argument is that since these features are identical, the performance will be equivalent.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for a "test set" for the modified device, nor its data provenance. The summary focuses on showing design and functional equivalence to the predicate. The "specific data on the performance of the test" is mentioned as being in Section V of the submission, but not summarized here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of substantial equivalence submission. There is no mention of experts establishing a ground truth for a test set in this document.

4. Adjudication Method for the Test Set

Not applicable for this type of substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an in vitro diagnostic reagent, not an imaging or interpretation device that would typically involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device is an "algorithm only" in the sense of being an automated chemical assay, the document does not present a standalone performance study with specific metrics for the modified device in this summary. Instead, it relies on the predicate's established performance to argue for substantial equivalence. The summary states that "Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission." This would likely contain data on precision, accuracy, linearity, etc., similar to a standalone study for the modified device, but these details are not provided in the 510(k) summary itself.

7. The Type of Ground Truth Used

Not applicable in the context of this summary. For an immunoturbidimetric assay, "ground truth" would typically refer to a reference method or a highly accurate comparative method used during validation studies (presumably for the predicate device and the modified device's internal validation), but this is not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that utilizes training sets in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

This document describes the validation of an in vitro diagnostic assay for Apolipoprotein A1.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated for method correlation. Precision studies were conducted using two levels of control material, but the number of unique samples or runs is not specified.
   • Data Provenance: Not explicitly stated, but typically these studies are conducted by the manufacturer at their facilities. No information on country of origin or retrospective/prospective nature is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is an in vitro diagnostic device for quantitative measurement, and "ground truth" is established through comparison with a legally marketed predicate device using quantitative performance metrics rather than expert consensus on interpretive tasks.

4. Adjudication method for the test set:

   • Not applicable. The "ground truth" for the test set is derived from the objective measurements obtained from the predicate device (for method correlation) and the device itself (for precision and sensitivity). There is no human adjudication process involved as would be for diagnostic image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI system acts as an assist. This submission is for an in vitro diagnostic assay with quantitative results.

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

   • Yes, the performance characteristics described (method correlation, precision, assay range, sensitivity) represent the standalone performance of the Apolipoprotein A1 assay on the AEROSET™ System. There is no human-in-the-loop component for the measurement and reporting of Apolipoprotein A1 levels by this automated assay.

7. The type of ground truth used:

   • For method correlation, the "ground truth" was the quantitative results obtained from the predicate device (K-ASSAY® Apo A1 on the Hitachi® 717 Analyzer). The new device's measurements were compared against these established measurements.
   • For precision and sensitivity, the "ground truth" refers to the inherent performance characteristics of the assay itself, demonstrating its consistency and lower detection limit.

8. The sample size for the training set:

   • Not applicable. This is a submission for an in vitro diagnostic chemistry assay, not a machine learning or AI algorithm that requires a separate training set. The assay's performance is based on its chemical and immunological principles, reagents, and instrument calibration, not on data-driven training in the sense of AI.

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

   • Not applicable, as there is no training set in the context of a machine learning algorithm for this type of device. The assay's analytical performance is developed and optimized through standard laboratory practices, reagent formulation, and instrument design.

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The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.

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The provided text is a 510(k) clearance letter from the FDA for the N-Assay TIA Apolipoprotein A-1 Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided input.

The document mainly focuses on the regulatory aspects of the device's clearance for marketing.

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The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.

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I am sorry, but based on the provided document, the information required to answer your request is not present. This document is an FDA 510(k) clearance letter for a medical device (N-Assay® A-1/B MULTI Calibrator Set), which primarily confirms substantial equivalence to a predicate device and outlines regulatory obligations.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

These details are typically found in the 510(k) submission itself or in separate technical documentation and clinical study reports, which are not included in this clearance letter.

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The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.

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This letter from the FDA is an approval for a medical device (N-Assay® TIA Apolipoprotein B Test Kit) and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a substantial equivalence (510(k)) pathway, which means the device was found to be as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies and acceptance criteria as would be needed for a Premarket Approval Application (PMA) for a novel device.

Therefore, I cannot fulfill your request using the provided text.

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