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QuikRead go® CRP: The QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument. Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use.

QuikRead go® CRP Control Set: The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use.

QuikRead go® CRP Verification Set: The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use.

QuikRead go® Instrument: The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.

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This document is a 510(k) premarket notification for the QuikRead go® CRP system, which includes the QuikRead go® CRP assay, Control Set, Verification Set, and Instrument. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or the study details to prove the device meets those criteria.

The provided text only outlines the indications for use of the various components of the QuikRead go® CRP system and regulatory information from the FDA. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Details on the type of ground truth used (e.g., pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

To obtain this information, one 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 FDA clearance letter.

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Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.

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The provided text is related to an FDA 510(k) clearance for a diagnostic device, the Orion Diagnostica UniQ™ PINP RIA. However, it does not contain any information regarding acceptance criteria, device performance, specific study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training set details.

The document is a clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a predicate device but does not present the data from the studies that led to this determination.

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

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The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.

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This is a 510(k) premarket notification for a Class I quality control material (Orion Diagnostica QuikRead® CRP Verification Set). The provided document is an FDA clearance letter and the "Indications for Use" statement. It does not contain a study or data proving the device meets acceptance criteria.

The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. For Class I devices like this, detailed performance studies with acceptance criteria are typically not required as part of the 510(k) submission itself, as these are often well-established technologies. The focus is on demonstrating that the new device is substantially equivalent to an existing one.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present.
4. Adjudication method: Not applicable/present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a verification set, not an algorithm.
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present.
9. How the ground truth for the training set was established: Not applicable/present.

Summary based on the provided document:

The provided document is an FDA clearance letter for a Class I quality control material. It confirms that the Orion Diagnostica QuikRead® CRP Verification Set is substantially equivalent to predicate devices for its intended use of "verification of calibration and method validation of the QuikRead CRP System." However, the document does not include any performance study data, acceptance criteria, or details of ground truth establishment. For Class I devices, the 510(k) process primarily focuses on demonstrating substantial equivalence, rather than requiring extensive clinical performance studies that would typically involve acceptance criteria and ground truth validation as described in your request.

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Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli.

QuikRead CRP Control Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument.

For in vitro diagnostic use.

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This letter is a 510(k) clearance letter from the FDA. It does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies. The letter primarily states that the device, Orion Diagnostica QuikRead® CRP kit and its control set, is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate performance study report.

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