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510(k) Data Aggregation
(335 days)
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
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range | Limit of Quantitation (LOQ): Not explicitly stated as an acceptance criterion, but determined according to CLSI EP17-A2. | LOQ: 5 mg/L (Serum) |
| Linearity: Not explicitly stated as an acceptance criterion, but evaluated according to CLSI EP06-A. Range should cover desirable range and extend to lowest and highest ends. | Linearity Range: 9.42 to 150.78 mg/L (Serum) | |
| Measuring Range: Not explicitly stated as an acceptance criterion, but based on LOQ and linearity studies. | Measuring Range: 5.0 to 160 mg/L (until 800 mg/L with post-dilution) | |
| Accuracy and Precision | Within-run CV limits: Low level: 9.0%, Middle level: 4.5%, High level: 3.8% | Within-run CV: All reported values for samples and controls are well below the limits (e.g., 0.8% - 1.8%) |
| Total precision CV limits: Low level: 12.0%, Middle level: 6.0%, High level: 5.0% | Total Precision CV: All reported values for samples and controls are well below the limits (e.g., 1.5% - 2.9%) | |
| Interferences | Acceptable bias is defined at +/-10% of the value without interfering substances. | Highest reported values for various interferents show no interference higher than 10%. |
| Matrix Comparison | Not explicitly stated as an acceptance criterion, but results should show no significant difference between serum and plasma with heparin specimens. | Correlation (R) of 0.996 and slope (0.8973 – 1.007) and intercept (-0.1611 – +0.6459) for 38 samples; concluded "no significative difference." |
| Method Comparison | Not explicitly stated as an acceptance criterion, but evaluated using NCCLS (CLSI) EP-9A3. | Correlation (R2) of 0.998 and slope (0.9680 – 0.9976) and intercept (-0.1357 – +0.6287) for 102 samples. |
| Reagent Stability | Closed stability: Stable up to the expiry date on the label if stored at 2-10°C. | Shelf Life: 24 months. |
| Open stability (on-board): Not explicitly stated as an acceptance criterion, but assessed. | On-board stability: 8 weeks. | |
| Reference Range | Verification studies should support established reference ranges in literature for adults: 20-60 years < 5 mg/L. | Verification studies support the reference range of < 5 mg/L for adults (20-60 years). |
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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