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The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay contains the following: strip wells coated with ZnT8 (96 wells in total) and supplied as 12 strips of 8 wells in a frame and sealed in a foil bag with desiccant; ready-to-use 4 levels of calibrators (10, 20, 75, and 500 U/mL, 5x0.7 mL each); one each ready-to-use positive I, positive II and negative control serum (1x0.7 mL); Zinc T8 Biotin (lyophilized) 3x5.5 mL (reconstituted); ready-to-use reconstitution buffer for Zinc T8 Biotin 2x15 mL (colored red); Streptavidin Peroxidase (SA-POD dilute before use) 1x0.7 mL; ready-to-use diluent for SA-POD 1x15 mL; ready-to-use peroxidase substrate (TMB) 1x15 mL; concentrated wash solution (dilute with deionized water before use) 1x125 mL and ready-to-use stop solution 1x12 mL.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds that the device must meet. Instead, it describes performance characteristics that were evaluated and determined to be acceptable for classification. The "clinical validation results must demonstrate clinical sensitivity and clinical specificity for the test values based on the presence or absence of Type 1 diabetes mellitus." The benefits and risks section effectively summarizes what was found and deemed acceptable.

Therefore, the table below reflects the presented clinical performance data which, given the overall conclusion, can be interpreted as the device meeting the implied acceptance criteria.

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

• Test Set Sample Size: 569 clinically defined patient samples.
  • 323 patients with Type 1 diabetes mellitus (T1D).
  • 246 patients from non-target disease groups (60 Type 2 diabetes mellitus, and 186 other autoimmune/medical conditions).
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, as the patients were "clinically defined" with existing diagnoses.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth for the clinical sample diagnoses. It simply states that the "diagnosis of Type 1 diabetes mellitus must be based on clinical history, physical examination, and laboratory tests, such as one or more pancreatic or insulin autoantibody test." Similarly, "Diseases for the differential groups must be based on established diagnostic criteria and clinical evaluation."

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for establishing the ground truth diagnoses for the clinical test set. It refers to diagnoses being "clinically defined" or based on "established diagnostic criteria and clinical evaluation."

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

No, an MRMC comparative effectiveness study was not done. This study assesses the standalone performance of the KRONUS Zinc Transporter 8 Autoantibody ELISA Assay. The device is intended to be used "in conjunction with other clinical and laboratory findings," but its performance is evaluated in isolation against clinical diagnoses.

6. If a Standalone Performance Study Was Done:

Yes, a standalone study was done. The performance characteristics (sensitivity, specificity) presented for the KRONUS ZnT8Ab ELISA Assay are based on the device's output alone compared to the clinical diagnoses of the 569 patient samples.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth for the test set was clinical diagnosis, based on:

• "clinical history, physical examination, and laboratory tests, such as one or more pancreatic or insulin autoantibody test" for Type 1 diabetes mellitus.
• "established diagnostic criteria and clinical evaluation" for the differential diagnosis groups.

This can be categorized as a form of clinical diagnosis/expert assessment, although the involvement of specific "experts" is not detailed.

8. The Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" for the development of the assay's core diagnostic algorithm (e.g., how the assay generates its U/mL values). The closest approximation to a "training" or "development" process is the determination of the assay cut-off.

• Assay Cut-off Determination: The cut-off of 15 U/mL was determined by testing 397 US healthy blood donors. This can be considered the dataset used to establish the "normal" range and thus define the threshold for a positive result.

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

For the assay cut-off determination:

• Ground Truth: The 397 individuals were identified as "healthy blood donors." This implies their healthy status was the ground truth against which the assay results were compared to set the cut-off.
• Method: 99% (394/397) of these healthy individuals were negative for ZnT8Ab. The mean and SD of results from these donors were used to establish the cut-off, with the goal of identifying 99th percentile or similar for negatives.

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The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

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The provided document describes a 510(k) premarket notification for a medical device, specifically the KRONUS Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit. It establishes substantial equivalence to a predicate device, but does not contain the information required to answer your specific questions about acceptance criteria and proof of performance through a study.

The document is a regulatory approval letter from the FDA, confirming that the device can be marketed. It details the device name, regulation number, regulatory class, product code, and indications for use. Key information like sample sizes, ground truth establishment, expert qualifications, and detailed study results are typically found in the submission itself, which is not provided here.

Therefore, I cannot provide the requested information based solely on the text you've given me. To answer your questions, I would need access to the actual 510(k) submission data, specifically the sections that detail the validation studies and performance data.

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The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semiquantitative determination of antibodies to voltage gated calcium channels in human serum. The VGCC antibody may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS). The assay result is not to be used alone and is to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically the "Kronus Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit." The document formally states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

FDA 510(k) clearance letters generally do not include the detailed study design, acceptance criteria tables, sample sizes, ground truth establishment, or expert qualifications that you've asked for. These details are typically found in the 510(k) submission itself, which is often a much longer and more technical document.

Therefore, I cannot provide the specific table and study information you've requested based solely on the provided text.

To answer your questions, one would need access to the actual 510(k) submission for K111956, which is generally not publicly available in its entirety without a Freedom of Information Act (FOIA) request to the FDA.

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The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).

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The provided text is an FDA 510(k) clearance letter for the KRONUS I123 Acetylcholine Receptor Blocking Antibody Kit (KRONUS Blocking AChRAb RIA Assay Kit). This document focuses on the regulatory approval process and includes the device’s indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and information based directly on the given text.

The information you are requesting, such as acceptance criteria and detailed study results, would typically be found in the manufacturer's 510(k) submission document itself, or potentially in a more comprehensive summary document provided by the FDA, but not in the clearance letter.

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The KRONUS TRAb ELISA Assay Kit is for the semi-quantitative determination of antibodies to the thyroid stimulating hormone receptor in human serum. The KRONUS TRAb ELISA Assay is useful as an aid in the diagnosis of Graves' Disease in conjunction with other clinical and laboratory findings.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the KRONUS TSH Receptor Autoantibody (TRAb) ELISA Kit. This document primarily focuses on the regulatory approval and substantial equivalence determination for an in vitro diagnostic (IVD) device, specifically an ELISA assay.

Therefore, the information typically requested for AI/ML device studies (such as acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance) is not available in these types of regulatory documents for IVD kits. These documents do not contain the detailed study protocols or results that would describe the performance against specific acceptance criteria for AI algorithms.

Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the format requested, as the information is not present in this regulatory letter.

This document confirms the device's classification and substantial equivalence to a predicate device, but it does not detail the specific performance studies and criteria that would be found in a clinical study report or a more technical submission for an AI/ML device.

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The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

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The provided text is a 510(k) clearance letter from the FDA for a medical device. This type of document confirms that a device is substantially equivalent to a previously marketed device, without requiring a full premarket approval application. It does not typically include the detailed technical study information that would allow me to populate the table and answer the specific questions about acceptance criteria and device performance as if it were an AI diagnostic device study.

Therefore, many of the questions cannot be answered based on the provided text alone. The text focuses on the regulatory clearance process rather than a detailed technical performance study.

However, I can extract what limited information is available and explain why other information is not present.

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

This information is not present in the provided document. The document is an FDA clearance letter, not a detailed study report. It mentions that the device is "substantially equivalent" to predicate devices, implying its performance is comparable, but does not provide specific acceptance criteria or reported performance metrics like sensitivity, specificity, or accuracy.

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

This information is not present in the provided document.

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)

This information is not present in the provided document.

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

This information is not present 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

There is no indication that an MRMC study was performed, and this device (KRONUS IA-2 Autoantibody RIA Assay Kit) is an in vitro diagnostic assay kit, not an AI-assisted diagnostic tool. Therefore, questions about human reader improvement with AI assistance are not applicable.

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

This question is not applicable as the device is an in vitro diagnostic assay kit, not an algorithm. The "standalone" performance would typically refer to the assay's performance itself, which is what would be evaluated. However, specific results from such an evaluation are not present in this document.

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

This information is not present in the provided document. For an assay kit, ground truth would typically be established through clinical diagnosis, often incorporating multiple factors beyond just the assay result.

8. The sample size for the training set

This information is not present in the provided document. For an in vitro diagnostic assay, there might not be a "training set" in the machine learning sense, but rather a set used for assay development and validation.

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

This information is not present in the provided document.

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The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

Not Found

This document is a 510(k) premarket notification letter from the FDA to KRONUS Market Development Associates, Inc. for their Insulin Autoantibody RIA Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

The letter only states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance for market. It refers to "indications for use" but does not provide performance metrics or study details.

Therefore, I cannot extract the requested information from the provided text.

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The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit

The provided text is related to a 510(k) premarket notification for a medical device called the "KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit." This document is a clearance letter from the FDA, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested in your prompt.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts or their qualifications, or adjudication methods for ground truth.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how ground truth was established for the training set.

The document is a clearance letter and focuses on the regulatory aspects of the FDA's decision, rather than the scientific and statistical details of the performance study. To get the requested information, one would typically need to review the actual 510(k) submission document or the device's Instructions for Use (IFU) or package insert, which would contain the performance study details.

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The KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.

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The provided K042248 document is a 510(k) clearance letter from the FDA for the Kronus I125 Acetylcholine Receptor Antibody Kit. This document does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria.

FDA 510(k) clearance letters primarily state that the device is substantially equivalent to a legally marketed predicate device and outline the regulatory classification and general controls. They typically do not include the raw data, study design, or performance metrics from the studies submitted in the 510(k) application itself.

Therefore, based solely on the provided text, I cannot extract the information required to populate the requested table and answer the study-related questions.

To answer your request, I would need access to the full 510(k) submission document or a summary of the performance data that was provided to the FDA by Kronus Market Development Associates.

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