Search Results
Found 42 results
510(k) Data Aggregation
(358 days)
The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE.
The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.
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The provided text is a 510(k) premarket notification letter from the FDA to Kamiya Biomedical Company regarding their K-ASSAY Cystatin C Assay. It mostly discusses the regulatory approval process and includes a brief "Indications for Use Statement". It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed 510(k) summary.
Therefore, I cannot extract the specific information you requested. The document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for test sets.
- Information about MRMC comparative effectiveness studies, effect sizes, or standalone algorithm performance.
- Details on the type of ground truth used or how it was established.
- Sample size or ground truth establishment for a training set.
This document is a regulatory approval letter, not a scientific study report. To get the requested information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing analytical and clinical performance studies, which are not included in this letter.
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(345 days)
The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.
K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
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This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "K-Assay® Microalbumin" and "K-Assay® Microalbumin Calibrator". This type of document typically confirms that a new device is "substantially equivalent" to an already legally marketed device, but it does not specify acceptance criteria or detailed study results.
Therefore, the requested information about acceptance criteria and the study proving the device meets them cannot be extracted from the provided text. The document primarily focuses on regulatory approval and classification rather than performance metrics.
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(253 days)
The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.
For in vitro diagnostic use.
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This document is a 510(k) clearance letter from the FDA for a medical device, specifically an in-vitro diagnostic test. It confirms that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain the acceptance criteria, study details, or performance data of the device.
The letter states that the FDA has reviewed the premarket notification, but it does not present the data from the studies that would have been submitted as part of that notification.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate performance study report, which is not included here.
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(113 days)
The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.
For in vitro diagnostic use.
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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "K-Assay® Total IgE Assay" and "K-Assay® IgE Calibrator." This document primarily communicates the FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
It does NOT contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information on expert ground truth establishment (number, qualifications, adjudication method).
- Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
This type of information would typically be found in the device's original 510(k) submission, specifically in the performance study sections, which are not included in this FDA decision letter. The letter confirms clearance but does not provide the underlying study data.
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(114 days)
The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.
The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.
For in vitro diagnostic use.
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I am sorry. This document is a letter from the FDA regarding the 510(k) premarket notification for the K-Assay D-Dimer Immunoturbidimetric Assay and Calibrator. It primarily discusses regulatory classification and approval to market the device.
Based on the provided text, there is no information available about the acceptance criteria or a study proving the device meets acceptance criteria.
The document details the following:
- Device Name: K-Assay® D-Dimer Immunoturbidimetric Assay and K-Assay® D-Dimer Immunoturbidimetric Calibrator
- Regulation Number: 21 CFR 864.7320
- Regulation Name: Fibrinogen/fibrin degradation products assay
- Regulatory Class: Class II
- Product Code: DAP: GHH
- Indications For Use: The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay. For in vitro diagnostic use.
To answer your request, I would need a different document that describes the performance study details for this specific device.
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(78 days)
The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.
The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
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The provided text is a 510(k) clearance letter from the FDA for a device called "K-Assay® CRP (3)". This document primarily addresses the substantial equivalence of the device and its intended use. It does not contain the specific information required to answer the questions about acceptance criteria and the study that proves the device meets those criteria.
The document states the device's indications for use: "The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases."
To answer your detailed questions about acceptance criteria and studies, a different type of document, such as the full 510(k) submission summary or a scientific study report, would be needed. These documents typically outline analytical and clinical performance studies, their methodologies, and results against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
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(24 days)
The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.
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While the provided text describes the FDA's decision regarding the K-ASSAY® Lp(a) Controls device, it does not contain any information about acceptance criteria, study details, or performance data. The document is a 510(k) clearance letter (K023853), which states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the requested information. The text focuses on regulatory approval rather than the technical details of the device's performance study.
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(16 days)
The K-ASSAY® hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.
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This document is an FDA 510(k) clearance letter for the K-ASSAY® hs-CRP Controls. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methods.
Therefore, I cannot fulfill your request for the information outlined. This type of detail is typically found in the 510(k) submission itself or in a separate summary document provided by the manufacturer, not in the clearance letter.
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(66 days)
The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay.
For in vitro diagnostic use.
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This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for clearance, not that a specific performance study with acceptance criteria has been detailed in this document.
To provide the requested information, a separate study report or regulatory submission document detailing the performance evaluation of the K-Assay® Lipoprotein (a) Immunoturbidimetric Assay would be necessary.
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(53 days)
The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and in the diagnosis and management of iron-related disorders such as hemochromatosis (iron overload) and iron deficiency anemia. The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay. For in vitro diagnostic use.
Not Found
This document, a 510(k) premarket notification, indicates FDA clearance for a device but does not contain detailed information about the acceptance criteria and the study that proves the device meets them. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone performance directly from the provided text. This information would typically be found in the device's documentation, such as a validation report or clinical study summary, which is not included here.
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