Search Results

The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma. It is supplied as a two-reagent kit. The kit contains Reagent 1 (Glycine buffer) and Reagent 2 (Anti-CRP polyclonal antibodies adsorbed on latex particles). Two different sizes of the product are available. The submission also describes CRP Calibrators (CRP Calibrator Set, CRP Calibrator HS, and CRP Calibrator WR) which are prepared by diluting CRP with human serum and stabilized by adding sodium azide.

Here's an analysis of the acceptance criteria and study as described in the provided document:

Acceptance Criteria and Device Performance for CRP Vario

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly refers to an "Acceptance Criteria" column for Method Comparison in Table 15-3. For other performance characteristics, the "acceptance criteria" can be inferred by comparing the candidate device's stated performance to that of the predicate device, or by general statements about meeting recommendations or consistency with original submissions.

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

• Method Comparison Test Set:

  • High Sensitivity Method: N = 111 human serum samples
  • Standard Method: N = 119 human serum samples
  • Wide Range Method: N = 119 human serum samples
  • Data Provenance: The document states "Human serum samples, spanning the measuring range, were tested." No information is provided regarding the country of origin or whether the data was retrospective or prospective.

• Limit of Quantitation (LoQ) Test Set:

  • The study used serum pools diluted with SeraSub (a synthetic serum) to create 8 low-level analyte samples (0.08, 0.06, 0.05, 0.04, 0.03, 0.02, 0.01, and 0.005 mg/dL).
  • Each sample was tested in a minimum of 10 replicates per run, with 2 runs per day over 3 days, resulting in a total of 60 replicates per sample.

• Linearity Test Set:

  • A high CRP serum pool was mixed with a low serum pool to generate 12 concentrations.
  • Each concentration level was tested in triplicate determinations.

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

This section is not applicable to this type of device and study. The CRP Vario is an in vitro diagnostic device that quantifies C-reactive protein. Its performance is evaluated against reference methods (e.g., predicate devices, established analytical protocols) and CLSI guidelines, not against expert human interpretations of images or clinical reports. There are no "experts" establishing a subjective ground truth in the way described for AI in image analysis.

4. Adjudication Method for the Test Set

This section is not applicable. As an in vitro diagnostic device, the performance is determined by quantitative measurements and statistical comparisons with reference methods, not by adjudication of interpretations by multiple human readers.

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

No, an MRMC comparative effectiveness study was not done. This type of study evaluates human reader performance often in the context of imaging diagnostics. The CRP Vario is an in vitro diagnostic for laboratory analysis, not a device requiring human interpretation in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reported here (Method Comparison, Linearity, Limit of Quantitation) are standalone performance evaluations of the CRP Vario assay. The device itself is an automated immunoturbidimetric system (ARCHITECT c8000 system) for quantitative measurement, operating without human interpretation of the final result, beyond standard laboratory quality control and result reporting.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the CRP Vario was established by:

• Reference Methods / Predicate Device: For the Method Comparison study, the candidate CRP Vario (traceable to ERM-DA472/IFCC) was compared against a Beckman Coulter CRP Latex REF. OSR6199 (traceable to CRM 470) on an AU5800 platform.
• CLSI Guidelines: Formal CLSI (Clinical and Laboratory Standards Institute) protocols (EP09-A3 for Method Comparison, EP06-A for Linearity, EP17-A2 for LoQ) were followed, indicating that the acceptable statistical and analytical measures defined by these standards served as the basis for evaluating performance.
• Dilution Series / Known Concentrations: For Linearity and LoQ, the "ground truth" was derived from precisely prepared serum pools and their serial dilutions to known or targeted concentrations.

8. The Sample Size for the Training Set

This section is not applicable. The CRP Vario is a re-submission for a modification of an existing in vitro diagnostic device, not an AI/ML device that requires a distinct "training set" in the computational sense. Its performance is characterized through analytical verification and validation studies.

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

This section is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrents, in patients with stable coronary disease or acute coronary syndrome.

Not Found

The provided text is a 510(k) Premarket Notification clearance letter for a device called "CRP Vario." This document primarily
confirms the FDA's determination of substantial equivalence for a medical device to
a legally marketed predicate device.

Crucially, this document focuses on regulatory clearance and does NOT contain the detailed study information required to answer the
questions about acceptance criteria and device performance.

Specifically, the document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• The "Indications for Use" section describes what the device is intended for (quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma, and its use as an aid in identification of individuals at risk for cardiovascular disease).

To answer your questions about the acceptance criteria and the study that proves the device meets them, one would typically
need access to the underlying 510(k) submission document itself or efficacy study reports, which are not part of this
publicly available clearance letter.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, training set size, or how ground truth was established.
3. Details about expert involvement (number, qualifications, adjudication methods).
4. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used.

Ask a specific question about this device

For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.

A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.

The provided text is a 510(k) premarket notification approval letter for a device called "CRP-ADVANCE." It describes the device's indications for use and general regulatory information but does not contain a study report or detailed acceptance criteria with performance results.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

Ask a specific question about this device

For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum.

The CRP-ADVANCE Multi-Calibrator Set, Cat. No. SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be use with the DCL CRP-ADVANCF Assay.

The provided document is a 510(k) premarket notification letter from the FDA regarding a CRP-ADVANCE Multi-Calibrator Set. This device is a calibrator used for in vitro diagnostic assays to quantify C-reactive protein in serum.

Given the nature of this device (a calibrator, not an AI/ML-driven diagnostic device or imaging device), the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, as typically applied to AI/ML or imaging diagnostics, is largely not applicable or would be addressed through different types of validation studies (e.g., analytical validation studies for calibrators).

Nevertheless, I will interpret the request based on the information that can be inferred or is typically required for such a device.

Here's an attempt to answer the questions, highlighting when information is not present in the provided document or is not applicable to this type of device:

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

The provided document (an FDA 510(k) clearance letter) does not contain detailed acceptance criteria or detailed performance data from a specific study. Instead, it states that the device is "substantially equivalent" to a legally marketed predicate device. For a calibrator, acceptance criteria would typically revolve around its ability to:

• Accurately assign values (e.g., target concentrations of C-reactive protein).
• Demonstrate stability over its shelf life.
• Show lot-to-lot consistency.
• Be compatible with the intended assay (DCL CRP-ADVANCE Assay).

The "reported device performance" is essentially the FDA's determination of substantial equivalence, meaning it performs as intended and is as safe and effective as the predicate device. Specific numerical performance metrics are not provided in this regulatory letter but would have been part of the 510(k) submission.

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 present in the FDA 510(k) clearance letter. For a calibrator, a "test set" wouldn't typically involve patient data in the way an AI diagnostic would. Instead, it would involve:

• A set of calibrator lots (for lot-to-lot variability studies).
• Reference materials or samples with known C-reactive protein concentrations (to verify assigned values).
• Samples tested on the DCL CRP-ADVANCE Assay using the calibrators.

The provenance (country, retrospective/prospective) is also not specified.

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 is not applicable in the context of this device. Calibrators do not have "ground truth" in the sense of expert human interpretation of images or clinical data. The "ground truth" for a calibrator would be its assigned concentration of C-reactive protein, which is established through rigorous analytical methods, often traceable to international reference standards or highly precise laboratory measurements, not subjective expert consensus.

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

This is not applicable for a calibrator. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers/experts when establishing ground truth for diagnostic decisions, typically in imaging or clinical scenarios.

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 not applicable to a calibrator. MRMC studies are used for evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. A calibrator is a foundational component of an assay; it doesn't involve human 'readers' or 'cases' in this manner, nor does it involve AI.

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

This is not applicable to a calibrator. A calibrator is a physical reagent set, not an algorithm, and does not have a "standalone performance" in the context of AI. Its performance is demonstrated through its ability to accurately calibrate an assay.

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

For a calibrator, the "ground truth" for its values (C-reactive protein concentrations) would be established by:

• Traceability to a primary reference material or standard: Often established through highly accurate analytical techniques, possibly gravimetric or spectroscopic methods, benchmarked against international standards.
• Value assignment studies: Using precise analytical methods within a well-controlled laboratory environment to determine the concentration of the analyte in each calibrator level.

This is a measured, analytically derived ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable to a calibrator in the way it applies to AI/ML devices. Calibrators are not "trained" on data. Their formulation and characteristics are developed through chemical and biological engineering, and their values are assigned through analytical validation.

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

This is not applicable as there is no "training set" for a calibrator. The "ground truth" of the calibrator's assigned values is established through the analytical methods described in point 7.

Ask a specific question about this device

CRP Vario is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

CRP Calibrators (CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum and EDTA or lithium heparinized plasma samples.

CRP Control US is intended for use as an assayed quality control material for serum C-reactive protein analysis.

The Sentinel CRP Vario kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein (CRP) in human serum and in heparinized and EDTAplasma. Human CRP antigens in the sample bind to the specific anti-CRP antibody absorbed to latex particles, and agglutination occurs. This agglutination is detected as an absorbance change when read on an automated chemistry analyzer at wavelengths between 550 - 580 nm. The magnitude of the change in absorbance is proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration using the CRP Calibrator Set, CRP Calibrator US, or CRP Calibrator WR.

The Sentinel CRP Calibrator Set, CRP Calibrator US and CRP Calibrator WR are prepared by diluting purified CRP with normal human serum to reach CRP concentrations of 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 and 48.0 mg/dL.

By using the CRP Vario with the Sentinel calibrator kits, each used with specific analyzer settings called Methods, three measuring ranges can be achieved. The combinations of calibrators, method used and analytical ranges are listed in Table 5.1.

The Standard and the Wide Range Methods can be used with any available commercial quality control materials. The CRP Vario with the Ultrasensitive Method requires a Sentinel control, CRP Control US, for the approximate CRP concentration of 0.05 mg/dL to ensure the effectiveness of CRP measurements at very low CRP concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided K050836 510(k) summary for the Sentinel CRP Diagnostic Assay:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary provided does not explicitly state pre-defined acceptance criteria (e.g., a specific target for sensitivity, precision, or correlation coefficient). Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data presented is comparative, showing "equivalence" rather than meeting pre-set numerical thresholds.

However, based on the information provided, we can infer the performance aspects evaluated and summarize the reported findings:

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

The 510(k) summary does not explicitly state the sample size used for the performance evaluations (sensitivity, precision, prozone, interference, and method comparison).

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that the submitter is from Italy (Sentinel CH Srl) and the contact person is also based in Rome, Italy, the studies might have been conducted in Italy or Europe, but this is not explicitly stated. The summary does not indicate whether the data was retrospective or prospective.

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

This information is not applicable in the context of this diagnostic assay submission. The "ground truth" for quantitative laboratory tests like CRP is typically established by reference methods or accepted clinical laboratory practices, not by expert consensus interpreting images or clinical cases. The comparison is done against existing, cleared diagnostic devices or reference standards.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is not established through expert review requiring adjudication in this type of diagnostic assay. The comparison is a quantitative measurement against known values or an established predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it typically be relevant for this type of in-vitro diagnostic device (IVD). MRMC studies are usually associated with diagnostic imaging devices or other tests that rely on human interpretation of complex data, where reader variability is a significant factor. The Sentinel CRP Diagnostic Assay is an automated immunoassay.

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

Yes, the device performance described (sensitivity, precision, prozone, interference, method comparison) represents standalone performance. The Sentinel CRP Vario is an automated immunoassay where human interaction is primarily for sample loading, initiating the test, and interpreting the numerical result from the automated analyzer. The "performance data" section explicitly discusses evaluations of the assay itself.

7. The Type of Ground Truth Used

The ground truth for evaluating the Sentinel CRP Diagnostic Assay consisted of:

• Reference materials/standards: For evaluating sensitivity, precision, prozone, and interference, these would typically involve samples with known CRP concentrations (e.g., spiked samples, control materials).
• Results from a predicate device: For the method comparison study ("comparison between the Sentinel CRP assay and the Beckman Coulter IMMAGE Immunochemistry System CRP reagent"), the results obtained from the predicate device (Beckman Coulter IMMAGE) served as a form of "ground truth" or reference for demonstrating equivalence.

8. The Sample Size for the Training Set

The 510(k) summary does not provide information regarding a "training set" sample size. This concept of a distinct training set is more common for machine learning or AI-based devices rather than traditional in-vitro diagnostic assays, which are typically developed and validated using a series of experiments with various samples.

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

As no training set is explicitly mentioned or relevant for this type of IVD in the provided summary, information on how its ground truth was established is not provided. The development of such assays involves established chemical and immunological principles, and calibration is performed using materials of known concentration (as described for the calibrator sets), rather than learning from a "training set" with established ground truth in the AI sense.

Ask a specific question about this device

The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.

The CRP(II) Calibrator is intended to be used for the calibration of the CRP-Latex(II)X2 SEIKEN

The provided text describes a 510(k) submission for the "CRP(II) Calibrators" device. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.).

The document primarily focuses on the regulatory submission process and states that the calibrators are intended for use with the CRP-Latex(II)X2 SEIKEN assay kit. It mentions "Performance data" but then immediately states: "The CRP-Latex (II) "Seiken"X2 High Sensitivity Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement." This implies that a detailed study demonstrating the calibrator's performance against specific acceptance criteria, as one would typically expect for a device, is not explicitly provided in this summary. Instead, it relies on substantial equivalence to a predicate device for the assay performance.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's an attempt to answer based on the limited information given:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not available. The document does not describe a specific test set for the calibrator's performance. It relies on the substantial equivalence of the CRP-Latex(II)X2 SEIKEN High Sensitivity Assay to a predicate device.

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

• Not available. There is no mention of a test set requiring expert ground truth establishment for the calibrator.

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

• Not available.

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 applicable. This device is a calibrator for a laboratory assay, not an AI-assisted diagnostic tool that would involve human readers.

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

• Not applicable. This is a calibrator, not an algorithm or AI.

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

• Not available. Since no specific study details are provided for the calibrators, the type of ground truth for performance assessment is not mentioned. For the assay itself, typically, established reference methods or primary standards would serve as ground truth for accuracy and precision studies, but such studies are not detailed here for the calibrator.

8. The sample size for the training set:

• Not available. The document does not describe a training set for the calibrator.

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

• Not available.

Ask a specific question about this device

The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

The CRP-Latex (II)X2 SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated chemistry analyzer (the Hitachi 917 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

Here's a breakdown of the acceptance criteria and the study details for the CRP-Latex (II)X2 SEIKEN Assay Kit, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 451 donor samples were used for the comparative performance studies.
   • Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective.

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

   • This information is not provided in the given text. The "ground truth" for the comparative study was the measurement given by the predicate device (N High Sensitivity CRP Assay).

3. Adjudication method for the test set:

   • This information is not applicable as the "ground truth" was established by a predicate device's measurements, not by human expert assessment requiring adjudication.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

   • Yes, the performance reported is a standalone (algorithm only) performance, comparing the output of the CRP-Latex (II)X2 SEIKEN Assay Kit to a legally marketed predicate device. The device itself is an automated immunoassay, not one that typically involves a human-in-the-loop for its basic measurement function.

6. The type of ground truth used:

   • The "ground truth" for the comparative performance study was the measurements obtained from the legally marketed predicate device, the N High Sensitivity CRP Assay (Dade Behring Inc.).

7. The sample size for the training set:

   • This information is not provided in the text. The study describes performance testing against a predicate device, not the development or training of an algorithm that would typically require a separate training set.

8. How the ground truth for the training set was established:

   • This information is not provided as a separate training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

Ask a specific question about this device

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.

The provided text describes the 510(k) summary for Good Biotech Corp.'s CRPex CRP Controls, intended for use as an assayed quality control material for serum C-reactive protein (CRP) analysis. It focuses on demonstrating substantial equivalence to a predicate device, Roche CRP T Control N.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are primarily demonstrating substantial equivalence to a predicate device by showing comparable characteristics. The "performance" is implicitly the C-reactive protein concentration range.

Note: While the exact "acceptance criteria" for the concentration ranges aren't explicitly stated as numerical targets that were met, the submission implies that these ranges are deemed acceptable for the intended use and demonstrate equivalence to the predicate control.

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

This document does not provide information on sample sizes used for a test set or data provenance for performance studies. As a quality control material, the "study" typically involves determining the assigned values and stability of the control, rather than a diagnostic performance study on patient samples.

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

This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values of CRP within the control, established through rigorous analytical methods and reference materials, rather than expert consensus on diagnostic images or clinical data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which are not applicable to the evaluation of a quality control material.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This document does not mention an MRMC comparative effectiveness study. MRMC studies are typically conducted for diagnostic devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. This is not applicable to a CRP control material.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable to the given device. The CRPex CRP Controls are a material used to assess the performance of other assay systems, not a standalone diagnostic algorithm. The "performance" of the controls themselves relates to their stability, homogeneity, and accurately assigned values, which are evaluated through analytical methods.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" refers to the assigned C-reactive protein concentrations within the various control levels (L, M, H). This would be established through:

• Quantitative analytical methods: Using a reference method or a highly accurate clinical analyzer calibrated against certified reference materials.
• Traceability to international standards: Ensuring the assigned values are traceable to recognized CRP standards.

The document states that the controls have "assigned C-reactive protein concentration," indicating this type of ground truth was established.

8. Sample Size for the Training Set

This information is not provided. As a quality control material, there isn't a "training set" in the context of machine learning or AI. The development of the control involves formulation, testing for stability, homogeneity, and value assignment, not training an algorithm.

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

This is not applicable as there is no "training set" in the context of this device. The ground truth (assigned CRP concentrations) for the control material itself would be established through analytical testing and value assignment protocols, as described in point 7.

Ask a specific question about this device

Good Biotech Corp. CRPex-BR C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.

Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.

This document describes the CRPex-BR C-reactive protein LIT assay, a device for the quantitative determination of C-reactive protein in serum. The submission aims to demonstrate its substantial equivalence to the predicate device, K-ASSAY CRP (1).

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

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format. However, substantial equivalence is claimed based on a correlation study comparing the CRPex-BR C-reactive protein LIT kit with the predicate device, K-ASSAY CRP (1). The performance is reported as a regression analysis and correlation coefficient:

Additional characteristics for substantial equivalence were presented, indicating the CRPex-BR device aims to match the predicate device in aspects such as intended use, methodology, test objective, test principle, type of test, specimen type, operating requirement, calibrator, sample volume, reagent volume, wavelength selection, and assay range. The interference results are also presented for comparison.

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

• Sample size for the test set: N = 94
• Data provenance: The document does not specify the country of origin of the data. It's also not explicitly stated whether the study was retrospective or prospective, but given it's a correlation study with patient samples, it's likely retrospective or a cross-sectional prospective study comparing results from the two devices on collected samples.

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

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" is typically established by comparative measurement to a gold standard or a well-established predicate device, rather than expert review of images or clinical cases. The predicate device (K-ASSAY CRP (1)) served as the reference for comparison, and its measurements were presumably used as the 'truth' for evaluating the new device.

4. Adjudication method for the test set

This information is not applicable/not provided for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or clinical outcomes, where human experts might disagree. For an assay comparing quantitative measurements, the comparison is directly between the numerical results of the two devices.

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 not applicable to this submission. MRMC studies are relevant for medical imaging AI devices where human readers interpret cases with and without AI assistance. This device is an in vitro diagnostic assay for C-reactive protein measurement, not an imaging interpretation tool. There is no human-in-the-loop interpretation intended for this device.

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

This concept is fundamentally applicable to this device, though the wording "algorithm only" is more typical for AI software. This device is an automated in vitro diagnostic assay. Its performance, as reported by the y = 0.976 x + 1.179 mg/L and R² = 0.998 correlation with the predicate device, represents its "standalone" performance. There is no human interpretation or intervention in the measurement process of the CRPex-BR assay itself, beyond operating the instrument and preparing samples.

7. The type of ground truth used

The ground truth for evaluating the CRPex-BR device was established by comparison to the results obtained from the predicate device, K-ASSAY CRP (1). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate is considered the established method.

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this. "Training set" is a concept primarily used in machine learning or AI where an algorithm learns from data. This device relies on chemical and immunoturbidimetric principles, not machine learning, so there is no "training set" in the AI sense.

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

As there is no "training set" in the AI sense for this device, this question is not applicable.

Ask a specific question about this device

Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.

The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples.

Here's an analysis of the provided text regarding the CRPex-HS CRP Calibrator Set, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the CRPex-HS CRP Calibrator Set is a 510(k) premarket notification for a device that is substantially equivalent to a predicate. As such, explicit "acceptance criteria" for performance are not typically presented in the same way they would be for a de novo device. Instead, the primary "acceptance criterion" is generally "substantial equivalence" to the predicate device.

For calibration devices, this usually involves demonstrating comparable performance characteristics, particularly in terms of correlation with the predicate device across a range of expected concentrations.

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

• Sample Size for Test Set: N = 67 (This refers to the number of data points used in the correlation study between the CRPex-BR CRP LIT Kit and the Wako CRP-UL predicate.)
• Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• This is a calibration device used with an immunoassay for measuring C-reactive protein. The "ground truth" for such a device is typically established through reference materials and methodologies, rather than expert consensus on diagnostic images or clinical outcomes.
• The document states that both the CRPex-HS CRP Calibrator Set and the predicate device are traceable to CAP/BCR/IFCC RPPHS, lot 91/0619. This implies that the 'ground truth' or accuracy of the calibrators is linked to this internationally recognized reference material, which would have been characterized by expert committees in the field of clinical chemistry/immunology. The number and specific qualifications of the experts involved in establishing this reference material are not provided within this 510(k) summary, as it's an external, established reference.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense. The test set involves quantitative comparison of CRP concentrations, not subjective interpretations requiring adjudication. The correlation study directly compares measurements from the test device's associated assay (CRPex-BR CRP LIT Kit) when calibrated by the test calibrator, against measurements given by the predicate calibrator.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a calibrator for an in vitro diagnostic assay, where direct human interpretation of the calibrator itself is not the primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not directly applicable in the typical sense for a calibrator. A calibrator is a physical substance used to set the measurement scale for an assay that then quantifies an analyte (CRP). It's not an "algorithm" in the way an AI diagnostic tool would be. However, the performance data provided (correlation, R²) effectively represents the "standalone" performance of the new calibrator in conjunction with its intended assay, compared to the predicate. The "human-in-the-loop" for this type of device would be the lab technician performing the assay, which is external to the calibrator's function itself.

7. The Type of Ground Truth Used

• The ground truth used for the CRP concentrations in the calibrators themselves is based on traceability to a recognized international reference material: CAP/BCR/IFCC RPPHS, lot 91/0619. This ensures the measured values of CRP in the calibrator are accurate and standardized.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. This device is a calibrator, not an AI system that learns from data.
• The reported "N = 67" likely refers to the number of samples or measurements in the correlation study (test set), not a training set.

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

• As a "training set" for an AI algorithm is not applicable here, this question is not relevant. The CRP concentrations in the calibrators are established through the manufacturing process and verified against the aforementioned international reference standard.

Ask a specific question about this device