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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 |
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(94 days)
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.
| Feature | Acceptance Criteria | Reported Device Performance (Candidate Device CRP Vario) | Met? |
|---|---|---|---|
| Method Comparison | |||
| High Sensitivity Method (Slope) | 0.95 – 1.05 | 0.969 (0.964 – 0.974) | Yes |
| High Sensitivity Method (R) | ≥ 0.975 | 1.000 | Yes |
| High Sensitivity Method (n) | ≥ 100 | 111 | Yes |
| Standard Method (Slope) | 0.95 – 1.05 | 0.956 (0.925 – 0.997) | Yes |
| Standard Method (R) | ≥ 0.975 | 1.000 | Yes |
| Standard Method (n) | ≥ 100 | 119 | Yes |
| Wide Range Method (Slope) | 0.95 – 1.05 | 0.976 (0.944 – 0.993) | Yes |
| Wide Range Method (R) | ≥ 0.975 | 1.000 | Yes |
| Wide Range Method (n) | ≥ 100 | 119 | Yes |
| Limit of Quantitation (LoQ) | |||
| LOQ for hsCRP | ≤ 0.03 mg/dL | "The LOQ results are consistent with the original submission." (Original submission stated 0.01 mg/dL for High Sensitivity Method, which is the hsCRP method). | Yes |
| LOQ for Standard and Wide Range Methods | ≤ 0.05 mg/dL | "The LOQ results are consistent with the original submission." (Original submission stated 0.02 mg/dL for Standard and Wide Range Methods). | Yes |
| Linearity | |||
| High Sensitivity Method | Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits. | Found to extend up to 16.00 mg/dL. | Yes |
| Standard Method | Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits. | Found to extend up to 32.00 mg/dL. | Yes |
| Wide Range Method | Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits. | Found to extend up to 48.00 mg/dL. | Yes |
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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