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The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 Antitrypsin deficiency. The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the SPIFE A1AT kit does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlines general regulatory requirements. It does not include the specifics of the performance study, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Details about expert involvement in ground truth establishment or adjudication methods.
• Information on MRMC studies or effect sizes.
• Whether standalone performance was evaluated.
• The type of ground truth used.
• How ground truth was established for the training set.

To obtain this information, you would typically need to refer to the 510(k) summary or the full 510(k) submission for the device, which are often available through the FDA's public databases or directly from the manufacturer. The clearance letter itself only confirms the regulatory approval.

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The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings.

The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2EDTA as the anticoagulant. The V8 Nexus Hemoglobin UltraScreen method uses capillary zone electrophoresis (CZE) buffer with the V8 instrument for the separation of normal hemoglobins (A, A2, and F) and detection of major hemoglobin variants (S and C). The V8 AFSA2 Hemo Control is a control material derived from whole blood used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system.

The V8 Nexus Hemoglobin UltraScreen is a medical device for the separation of normal hemoglobins (A, A2, and F) and the detection of major hemoglobin variants (S and C) in human blood samples. The device uses capillary zone electrophoresis (CZE) and is indicated for in-vitro diagnostic use in patients 2 years of age and older.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the precision/reproducibility and comparison studies. For the precision studies, the acceptance criteria would be the measured standard deviation (SD) and coefficient of variation (CV) of the hemoglobin fractions. For comparison studies, the acceptance criteria are generally an R-value close to 1, a slope close to 1, and an intercept close to 0, along with acceptable confidence intervals.

Linearity Acceptance Criteria and Performance:

Limit of Detection (LOD) and Limit of Quantitation (LOQ) Acceptance Criteria and Performance:

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

The "test set" in this context refers to the clinical samples used for the comparison studies with the predicate device.

• Sample Size for Comparison Studies (Test Set): A total of 439 patient samples were used across three external sites.
  • Hb A quantitation: 320 samples
  • Hb A2 quantitation: 412 samples
  • Hb F quantitation: 175 samples
  • Presumptive Hb S: 143 samples
  • Presumptive Hb C: 33 samples
• Data Provenance: The data comes from three external sites, suggesting a multi-center study setup. The samples were "fresh venous K2-EDTA-anticoagulated whole blood," indicating that these were prospective or recently collected samples for analysis. The country of origin is not explicitly stated, but given the submitter's address (Beaumont, Texas, USA) and FDA submission, it is likely the studies were conducted in the USA.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the "ground truth" for the comparison studies was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491).

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison studies directly compared the performance of the V8 Nexus Hemoglobin UltraScreen to the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic assay for analyzing blood samples, not an image-based diagnostic that involves human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are standalone (algorithm only) performance assessments of the V8 Nexus Hemoglobin UltraScreen instrument. These are bench-top studies and comparison studies demonstrating the device's analytical performance on its own, without direct human intervention in the interpretation of the capillary electrophoresis data beyond routine laboratory procedures. The instrument is described as an "automated analyzer."

7. The Type of Ground Truth Used

• For the precision/reproducibility studies, the ground truth was the known composition/percentages of hemoglobin fractions in the controls (AFSA2 and AFSC hemoglobin controls) and patient samples.
• For the comparison studies, the ground truth was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491). This is a common approach for 510(k) submissions, where substantial equivalence to a legally marketed predicate device is demonstrated.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of a machine learning algorithm. This device is a quantitative assay using capillary zone electrophoresis (CZE), a well-established analytical technique. While the term "training" might apply to calibration or method development, a distinct "training set" with established ground truth as would be used for AI/ML validation is not detailed here. The studies focus on analytical validation (precision, linearity, LOD/LOQ, analytical specificity) and comparison to a predicate.

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

As no specific "training set" for an AI/ML algorithm is described, the method for establishing its ground truth is not applicable in this document. The device's performance is validated against established laboratory standards, controls, and a predicate device.

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V8 SP Normal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

V8 SP Abnormal Control is to be used as a qualitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

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I am sorry, but this document contains no information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Helena Laboratories for a device called "V8 SP Normal Control and V8 SP Abnormal Control". It primarily discusses the regulatory classification of the device and general compliance requirements, but does not include any performance data or study details.

Therefore, I cannot provide the requested information based on the provided text.

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The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's IgG, IgA, IgM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests.

For In Vitro Diagnostic Use Only.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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The provided document is an FDA 510(k) clearance letter for the "V8 Immunodisplacement Kit" and does not contain the detailed study information required to fully answer the request. This document primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.

Therefore, I cannot provide all the requested information. However, I can extract what is available and note what is missing.

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

This information is not available in the provided document. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail specific acceptance criteria or performance metrics from a study.

2. Sample size used for the test set and the data provenance

This information is not available in the provided document.

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

This information is not available in the provided document.

4. Adjudication method for the test set

This information is not available in the provided document.

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

This information is not available in the provided document. The device described (V8 Immunodisplacement Kit) is for in vitro diagnostic use involving capillary electrophoresis and visual evaluation of electrophoretograms. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or similar data.

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

This information is not available in the provided document. As mentioned, this device appears to be an in vitro diagnostic kit with visual evaluation by a human.

7. The type of ground truth used

This information is not available in the provided document. For this type of device (detection and characterization of monoclonal proteins), ground truth would likely involve established laboratory methods or clinical diagnoses.

8. The sample size for the training set

This information is not available in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context may not apply.

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

This information is not available in the provided document.

Summary of available information from the document:

• Device Name: V8 Immunodisplacement Kit
• Intended Use: Detection and characterization of monoclonal proteins (IgG, IgA, IgM, kappa (bound), and lambda (bound) light chains) in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit.
• Evaluation Method: Electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with suspect monoclonal proteins.
• Context of Use: Test results are to be used in conjunction with clinical findings and other laboratory tests.
• Regulatory Status: 510(k) clearance based on substantial equivalence to legally marketed predicate devices.
• Classification: Class II, Product Codes: CFF (Immunoglobulins A, G, M, D, and E immunological test systems).
• Prescription Use: Yes.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance, one would typically need to review the 510(k) submission summary or additional technical documentation provided by Helena Biosciences Europe to the FDA, which is not part of this clearance letter.

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Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aqqreqation of functional platelets is measured using an electronic impedance-base cell counter.

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This is an FDA Premarket Notification (510(k)) letter for the Plateletworks Arachidonic Acid device. This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device and can proceed to market.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the provided text, the following can be inferred or stated:

• Device Name: Plateletworks Arachidonic Acid (PW-ACA)
• Intended Use: An in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aggregation of functional platelets is measured using an electronic impedance-based cell counter.

Here's what cannot be found in the provided text:

• Acceptance criteria and reported device performance table
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

To obtain these details, one would typically need to refer to the 510(k) summary document, which is a public summary of the information provided in the 510(k) submission, including performance data and a discussion of substantial equivalence.

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The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings.

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I am sorry, but the provided text is a regulatory clearance letter from the FDA and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The document states that the device, "SPIFE® IFE-3 Pentavalent Kit, SPIFE® IFE-6 Pentavalent Kit, SPIFE® IFE-9 Pentavalent Kit, SPIFE® IFE-15 Pentavalent Kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" as: "The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings."

However, it does not provide any specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets), details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, ground truth, training set information), or effectiveness studies (MRMC or standalone performance).

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The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

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This document section appears to be an FDA 510(k) clearance letter for a medical device called "Actalyke® QC Kits QAC-HP, AQC-LP." It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding the acceptance criteria, device performance data, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General controls and regulations applicable to the device.
• The intended use of the device: "The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided document. This type of detailed study data is typically found in the 510(k) submission itself or in separate technical reports, not usually in the FDA clearance letter.

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The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von Willebrand's disease. "Nibeoous" reagents are used to quantitate the von Willebrand factor activity.

AggRAM Analyzer

The provided text is a 510(k) clearance letter for the HemoRam/AggRAM Analyzer System and its indications for use. It does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed devices.

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The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis

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The provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE 3000 Titan Gel IgG IEF Kit". This document primarily focuses on regulatory approval based on substantial equivalence, and not on the detailed reporting of a study that establishes acceptance criteria and proves the device meets them in the way modern AI/ML device submissions would.

Therefore, the information you're requesting regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.

The document states the indications for use: "The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis."

However, it does not include the detailed performance study results that would typically define "acceptance criteria" and "reported device performance" in the format you've requested. The FDA's 510(k) clearance process for this type of device (from 2003) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, de novo clinical trial data with predefined acceptance metrics and detailed statistical analysis on a test set.

In summary, the input text does not contain the information necessary to fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes and data provenance for test sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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