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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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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.

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