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Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using the 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 is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.

Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control

The provided document is a 510(k) premarket notification letter for the Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control. It is a communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed study information required to answer your questions about acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter confirms substantial equivalence based on information submitted by the manufacturer, but it does not typically include the full technical and clinical study report itself. That information would be found in the manufacturer's 510(k) submission packet, which is much more extensive and generally not made public in detail alongside the clearance letter.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• 1. A table of acceptance criteria and the reported device performance: Not available in this document.
• 2. Sample sized used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
• 4. Adjudication method for the test set: Not available in this 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: Not available in this document. (This device is an in-vitro diagnostic kit for C-reactive protein, not an AI-assisted diagnostic imaging device for human readers.)
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. (This device is a quantitative assay, not an algorithm.)
• 7. The type of ground truth used: Not available in this document.
• 8. The sample size for the training set: Not available in this document.
• 9. How the ground truth for the training set was established: Not available in this document.

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Orion Diagnostica High Sensitivity CRP (HS-CRP) is an in vitro diagnostic assay intended for the quantification of low concentrations (ca. 0.25 - 10.0 mg/l) of C-reactive protein (CRP) in human serum or plasma (EDTA or heparin) by means of particle enhanced immunoturbidimetry using a Hitachi 911 or 917 analyzer. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

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The provided text is a 510(k) clearance letter from the FDA for the "Orion Diagnostica High Sensitivity CRP (HS-CRP)" device. It states that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use for quantifying C-reactive protein in human serum or plasma.

However, the document does not contain the detailed information requested regarding:

• Acceptance criteria and reported device performance (in a table format).
• Sample size and provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) study results or effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• Ground truth establishment for training sets.

This type of information is typically found in the 510(k) submission document itself, which is a much more extensive technical file than the clearance letter provided here. The clearance letter only confirms that the FDA has reviewed the submission and found the device substantially equivalent.

Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based solely on the provided text.

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Pyloriset EIA-G is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori. The product is intended for use to test patients with symptoms of gastrointestinal disorders.

Pyloriset EIA-G is a qualitative enzyme immunoassay.

The provided text is a 510(k) clearance letter for the Pyloriset EIA-G device and contains limited information regarding performance studies. Based on the available text, I can infer some details, but much of the requested information is not present.

Here's an attempt to answer your questions based only on the provided text, with clear indications where information is missing:

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

The document does not explicitly state acceptance criteria or provide a table of reported device performance. It only indicates that the device has been found "substantially equivalent" to a predicate device.

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

This information is not available in the provided text.

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 available in the provided text. The device is for "detection of Helicobacter pylori specific IgG antibodies in human serum," which typically relies on laboratory-based ground truth (e.g., culture, biopsy, or other validated H. pylori tests), not necessarily expert human review of images.

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

This information is not available in the provided text. Given it's an immunoassay, human adjudication in the traditional sense for image interpretation would not apply. Ground truth would be established by laboratory methods.

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 is an immunoassay for detecting antibodies, not an AI-powered diagnostic imaging device. Therefore, an MRMC study and its associated effect size on human readers are not applicable and not mentioned in the provided text.

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

The Pyloriset EIA-G is described as a "qualitative enzyme immunoassay." As an immunoassay, its performance is inherently "standalone" in the sense that it provides a result based on the chemical reaction. Performance studies for such devices typically evaluate their accuracy, sensitivity, and specificity against a gold standard, which would constitute standalone performance. However, specific details of such a study are not provided in the text.

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

The document states the device "is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori." For a device like this, the ground truth would typically be established through highly accurate and accepted methods for H. pylori infection diagnosis, such as:

• Histopathology (biopsy with identification of H. pylori)
• Culture of H. pylori from biopsy
• Urea breath test or stool antigen test (which are highly accurate for active infection)
• A combination of these or a validated reference assay.

However, the exact type of ground truth used in the studies for this specific device is not explicitly stated in the provided text.

8. The sample size for the training set

The provided text describes a 510(k) clearance letter for an immunoassay. The concept of a "training set" is primarily relevant to machine learning/AI algorithms. Immunoassays are based on biochemical reactions and do not typically involve "training sets" in the same way. The development and validation of an immunoassay involve optimizing reagents and protocols, and then testing on clinical samples. The sample size and methodology for such validation are not available in the provided text.

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

As with point 8, the concept of a "training set" for an immunoassay is not directly analogous to AI. Therefore, how ground truth for a "training set" was established is not applicable and not mentioned in the provided text. The ground truth for the clinical samples used in the performance study (if described) would be established by methods mentioned in point 7.

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