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Yumizen C1200 CRP reagent is intended for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and lithium heparin plased on an immunoturbidimetric assay. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infections, tissue injury and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.

Yumizen C1200 CRP (Licensed for USP6, 248, 597/ USP6, 828, 158 and equivalent patents in other countries) is a latex-enhanced immunoturbidimetric assay developed to accurately measure CRP levels in serum and plasma samples for conventional CRP ranges.

When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP antibody which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change, 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.

Reagents Yumizen C1200 CRP is ready-to-use.

Reagent 1: Buffer solution: Glycine buffer solution Reagent 2: Latex suspension: 0.20% w/v suspension of latex particles sensitized with anti-CRP antibodies (rabbit)

After measurements are taken, reagent cassettes should remain in the refrigerated tray.

Care should be taken not to interchange the caps with others cassettes.

Reagents with different lot numbers should not be interchanged or mixed.

This submission consists of the Yumizen C1200 CRP (1300023877) reagent for serum and plasma testing for Yumizen C1200 reagent CRP, the submission includes the controls Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer. The submission for Yumizen C1200 reagent CRP also includes the corresponding calibrator Yumizen C1200 CRP Cal (1300023899) for use on Yumizen C1200 Analyzer.

The acceptance criteria and study proving the device meets them are detailed below for the Yumizen C1200 CRP reagent.

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

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

• Limit of Quantitation (LOQ): Five samples were used, assayed over five days, with two runs of four replicates per sample per day (for each reagent lot). These samples came from diluting individual serum samples by commercial depleted serum.
• Linearity: Each level of a range of samples (covering 9.42 to 150.78 mg/L) was assayed 3 times. The highest concentration sample was pooled human sera spiked with CRP stock solution.
• Total Precision (20x2x2):
  • Sample Size: 240 measurements per sample/control (20 days * 2 series/day * 2 replicates/series * 3 analyzers * 3 reagent lots, assuming pooling of data) for 5 specimens (pooled human sera) and 2 controls (Yumizen C1200 Level 1 and 2 Protein Control).
  • Provenance: Pooled human sera were anonymous remnants of human sera specimens collected from routine clinical laboratory.
• Instrument Variability (3x5x2x3):
  • Sample Size: 90 measurements per sample/control (3 instruments * 5 days * 2 series/day * 3 replicates/series) for 6 samples (pooled human sera) and 2 controls (Yumizen C1200 Level 1 and 2 Protein Control).
  • Provenance: Pooled human sera were anonymous remnants of human sera specimens collected from routine clinical laboratory.
• Lot to Lot Variability (3x5x2x3):
  • Sample Size: 90 measurements per sample/control (3 reagent lots * 5 days * 2 series/day * 3 replicates/series) for 6 samples (pooled human sera) and 2 controls (Yumizen C1200 Level 1 and 2 Protein Control).
  • Provenance: Pooled human sera were anonymous remnants of human sera specimens collected from routine clinical laboratory.
• Interferences: Pooled Human sera were used. Substances were added to base sera at two different CRP concentrations (normal and high).
• Exogenous Interferences (Matrix Comparison): 38 paired samples (sera and heparinized plasma) from individual donors from a blood bank were evaluated. Only native samples were used.
• Method Comparison: 102 native samples were used, assayed in duplicate. These samples were anonymous remnants of human serum specimens collected from routine clinical laboratory.
• Reference Range: 80 "normal samples" from a blood bank were assayed in duplicates.

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 given text. For an in vitro diagnostic device like the Yumizen C1200 CRP, the "ground truth" for quantitative measurements is typically established through reference methods or established calibrators, not through expert consensus in the same way an imaging AI algorithm's ground truth might be. The reference ranges are verified against literature, not established by experts for the study itself.

4. Adjudication method for the test set

This information is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology reads for an AI algorithm), not for quantitative analytical performance studies of a laboratory instrument and reagent.

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 information is not applicable as this is an in vitro diagnostic device for C-reactive protein (CRP) measurement, not an AI-assisted diagnostic tool that involves human readers/interpreters.

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

This is a standalone diagnostic system (instrument + reagent) for measuring CRP. Its performance is entirely "algorithm only" in the sense that the instrument provides a quantitative result without human-in-the-loop interpretation of raw data, beyond operating the instrument and interpreting the numerical output. The studies detailed (linearity, precision, interference, method comparison) are all evaluating this standalone performance.

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

The "ground truth" for the performance characteristic studies of the Yumizen C1200 CRP reagent is established through:

• Reference methods and calibrators: For accuracy and linearity, performance is assessed against known concentrations or calibrated materials (e.g., using ERM-DA 474 or IRMM/ERM-DA472/IFCC for traceability).
• Statistical analysis: Precision measurements rely on statistical reproducibility.
• Comparative methods: Method comparison studies compare the device's results to a legally marketed comparator device (BECKMAN COULTER CRP reagent model: CRP LATEX REAGENT OSR6199 on Olympus AU400).
• Reference literature: The reference range for CRP is verified against established scientific literature.

8. The sample size for the training set

This information is not applicable as this is an in vitro diagnostic device, not a machine learning or AI model that requires a "training set." The development of the reagent and instrument might involve internal optimization, but it's not described in terms of a formal "training set" like an AI model.

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

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

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Yumizen C1200 CRP reagent is intended for use as a high sensitive assay for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

Yumizen C1200 CRP reagent is intended for use as a high sensitive assay for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.

The provided text describes the analytical performance characteristics of the Yumizen C1200 CRP device, supporting its substantial equivalence claim for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various analytical performance characteristics (measuring range, accuracy, precision, interferences, matrix comparison, method comparison, and reagent stability) but does not explicitly state acceptance criteria in a single, dedicated table with pass/fail results. Instead, it presents the study methods and the results obtained, often followed by a statement indicating whether the results are "within specifications" or "appropriate." The acceptance criteria are implicitly defined by the chosen CLSI guidelines and the internal specifications of HORIBA Medical.

Based on the information provided, here's a table summarizing the reported device performance and the implicit acceptance as demonstrated by the study results:

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

• Measuring Range (Linearity): Not explicitly stated how many samples were used, but the method refers to CLSI EP06-A.

• Accuracy and Precision:

  • Serum: 240 measurements for each of 5 samples/controls (internal control, Sample 1-4) in both "calibration every week" and "calibration only at beginning" studies.
  • Heparin-Lithium: 20 measurements for each of 6 specimens.

• Interferences: Not explicitly stated how many samples were tested for each interfering substance, but the study method refers to CLSI EP07-A2.

• Matrix Comparison (Serum vs. Heparin-Lithium): 54 samples.

• Method Comparison (with comparator device): 138 native samples.

• Data Provenance:

  • The document states "Anonymous remnants of human serum specimens collected from routine clinical laboratory" for some studies (precision for lithium-heparin, method comparison). For the matrix comparison, it mentions "individual donors from blood bank (in serum and plasma for each donor)".
  • The studies appear to be retrospective as they use "remnants" and "collected" samples.
  • The country of origin is not explicitly stated, but the manufacturer (HORIBA ABX SAS) is based in Montpellier, France, suggesting the studies were likely conducted in France or a European context.

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

This device (Yumizen C1200 CRP) is an in vitro diagnostic device for quantitative measurement of C-reactive protein (CRP) in human serum and plasma. For such devices, ground truth is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods (e.g., mass spectrometry, or comparison to a cleared predicate device).
• Certified Reference Materials: Samples with a known and certified concentration of the analyte.

The document does not mention the use of human experts (like radiologists for image analysis) to establish ground truth for the test set of this type of device. The accuracy and precision are determined by comparing results to expected values or reference materials, and the method comparison is done against a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. As described above, for IVD devices like this, ground truth is established through analytical precision and accuracy, reference methods, and comparison against a predicate device, not through human reader adjudication like in imaging studies.

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

No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret images. This device is a laboratory assay; therefore, MRMC studies are not applicable.

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

Yes, the entire analytical performance evaluation (measuring range, precision, interference, matrix comparison, method comparison, stability) describes the standalone performance of the Yumizen C1200 CRP device. This is typical for IVD devices where the result is generated solely by the analyzer and reagent system, without human interpretive input altering the result itself.

7. The Type of Ground Truth Used:

• Certified Reference Materials/Control Materials: Used for precision and accuracy studies (e.g., "Low CRP Control (internal control)").
• Native Patient Samples: Used for matrix comparison and method comparison studies (comparison against a predicate device).
• Spiked Samples: Used for interference studies (adding known interferents to samples).
• Reference Methods/Predicate Device: The predicate device (VITROS Chemistry Products hsCRP Reagent K160712) served as the comparative "ground truth" for method comparison and demonstrating substantial equivalence. The document explicitly states the method comparison was carried out using recommendations from CLSI EP-9A3 ("Measurement Procedure Comparison and Bias Estimation Using Patient Samples").

8. The Sample Size for the Training Set:

The document describes pre-market validation studies for a medical device submitted for 510(k) clearance. For traditional IVD devices (non-AI/ML based), there isn't typically a "training set" in the machine learning sense. The "training" of the device is inherent in its design, calibration, and manufacturing process. The studies described are validation and verification studies to demonstrate performance.

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

Not applicable, as there is no "training set" in the context of an AI/ML device for this traditional IVD product. The calibration curves for the device are established during the development phase using calibrator materials, which would have their values traceable to a higher-order reference method or standard. The document mentions "Yumizen C1200 CRPhs Cal" as the calibrator used, and its properties would be traceable to ensure accurate measurements.

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