(335 days)
No
The device description and performance studies focus on a standard immunoturbidimetric assay for CRP measurement, which relies on chemical reactions and optical detection, not AI/ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic reagent used to measure C-reactive protein levels, which aids in evaluating injury, infections, and inflammatory disorders. It does not directly treat or cure any medical condition.
Yes
The device is intended for the "quantitative in vitro diagnostic determination of the C-reactive protein in human serum" and to "aid in evaluation of the amount of injury to body tissues and for evaluation of infections, tissue injury and inflammatory disorders." These are diagnostic purposes.
No
The device is a reagent for an in vitro diagnostic test, which is a physical component used in a laboratory setting. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and lithium heparin plasma". The phrase "in vitro diagnostic" is a direct indicator.
- Purpose: The purpose of the test is to "aid in evaluation of the amount of injury to body tissues and for evaluation of infections, tissue injury and inflammatory disorders," which are clinical conditions.
- Sample Type: The device analyzes human serum and plasma, which are biological specimens.
- Method: It uses an "immunoturbidimetric assay," a common laboratory technique for measuring substances in biological fluids.
- Regulatory Context: The mention of a predicate device (K142993) and a reference device (K051564) with K numbers indicates that this device is undergoing a regulatory process for medical devices, specifically IVDs.
- Intended User/Care Setting: The statement "For in vitro diagnostic use only. Not for point-of-care use" further confirms its classification as an IVD used in a laboratory setting.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a transplant organ, tissue or blood with a potential recipient, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
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.
Product codes
DCK
Device Description
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)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults: 20-60 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Measuring Range
The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2.
- Low concentrations samples assayed with two reagent lots, one instrument system, for five days. Five samples, two runs, four replicates per run per sample (for each reagent lot, each day), and one technician. Samples came from dilution of individual serum samples by commercial depleted serum.
- Linearity evaluated using a range of samples at different concentrations covering the desirable range, extended at the lowest and highest ends. Each level assayed 3 times. Highest concentration sample used was a pooled human sera sample spiked with CRP stock solution.
- Results:
| | Limit of detection | Limit of quantitation | Linearity Evaluated | Measuring range |
|----------------------------|--------------------|-----------------------|----------------------|------------------|
| Serum | 0.23 mg/L | 5 mg/L | 9.42 to 150.78 mg/L. | 5.0 to 160 mg/L, |
| Serum Post-dilution | NA | NA | up to 737.40 mg/L | until 800 mg/L | - Linearity (9.42 – 150.78 mg/L): Slope 1.026 (95%CI: 1.005 – 1.047), Intercept -1.33 (95% CI: -3.23 – +0.58), R2 0.9972.
The limit of quantitation and the linearity studies showed that claimed measuring range is appropriate.
Accuracy and Precision (CLSI document EP5-A3)
-
Total Precision: 20x2x2 study. Studied materials: Yumizen C1200 Level 1 Protein Control, Yumizen C1200 Level 2 Protein Control, Pooled human sera (anonymous remnants of human sera specimens).
-
Performed using 3 analyzers and 3 reagent lots. Dedicated controls and 5 specimens (low, medium, high) tested in duplicate for 20 days, two series per day.
-
Results:
| Sample | N | Mean (mg/L) | SD | %CV (Within-run) | SD | %CV (Between-run) | SD | %CV (Between-day) | SD (Between-instrument) | %CV (Between-instrument) | SD | %CV (Total) |
|-----------|-----|-------------|-------|------------------|-------|-------------------|-------|-------------------|-------------------------|--------------------------|-------|-------------|
| 1 | 240 | 5.06 | 0.042 | 0.8 | 0.053 | 1.0 | 0.125 | 2.5 | 0.037 | 0.7 | 0.147 | 2.9 |
| 2 | 240 | 9.79 | 0.075 | 0.8 | 0.075 | 0.8 | 0.083 | 0.8 | 0.052 | 0.5 | 0.144 | 1.5 |
| 3 | 240 | 27.61 | 0.208 | 0.8 | 0.388 | 1.4 | 0.629 | 2.3 | 0.000 | 0.0 | 0.768 | 2.8 |
| 4 | 240 | 65.33 | 0.597 | 0.9 | 0.582 | 0.9 | 0.921 | 1.4 | 0.303 | 0.5 | 1.279 | 2.0 |
| 5 | 240 | 141.27 | 2.546 | 1.8 | 0.000 | 0.0 | 2.372 | 1.7 | 0.976 | 0.7 | 3.614 | 2.6 |
| Control 1 | 240 | 16.57 | 0.130 | 0.8 | 0.235 | 1.4 | 0.338 | 2.0 | 0.000 | 0.0 | 0.432 | 2.6 |
| Control 2 | 240 | 74.88 | 0.637 | 0.9 | 0.888 | 1.2 | 0.847 | 1.1 | 0.567 | 0.8 | 1.494 | 2.0 | -
Within run CV limits: low 9.0%, middle 4.5%, high 3.8%. Total precision CV limits: low 12.0%, middle 6.0%, high 5.0%. Results are within specifications.
-
Instrument variability: 3x5x2x3 study. Study materials: Yumizen C1200 Level 1 Protein Control, Yumizen C1200 Level 2 Protein Control, Pooled human sera.
-
One reagent lot, three instrument systems, 2 controls and 6 samples tested in triplicate for 5 days, two series per day. Calibrations done at the beginning of the study.
-
Results:
| Sample | N | Mean (mg/L) | SD (Within-day) | %CV (Within-day) | SD (Between-day) | %CV (Between-day) | SD (Within-instrument) | %CV (Within-instrument) | SD (Between-instrument) | %CV (Between-instrument) | SD (Total) | %CV (Total) |
|-----------|----|-------------|-----------------|------------------|------------------|-------------------|------------------------|-------------------------|-------------------------|--------------------------|------------|-------------|
| 1 | 90 | 5.16 | 0.055 | 1.1 | 0.066 | 1.3 | 0.086 | 1.7 | 0.104 | 2.0 | 0.135 | 2.6 |
| 2 | 90 | 9.80 | 0.085 | 0.9 | 0.049 | 0.5 | 0.098 | 1.0 | 0.094 | 1.0 | 0.136 | 1.4 |
| 3 | 90 | 25.44 | 0.268 | 1.1 | 0.174 | 0.7 | 0.319 | 1.3 | 0.653 | 2.6 | 0.727 | 2.9 |
| 4 | 90 | 71.28 | 0.944 | 1.3 | 1.078 | 1.5 | 1.433 | 2.0 | 0.884 | 1.2 | 1.683 | 2.4 |
| 5 | 90 | 94.77 | 1.227 | 1.3 | 0.714 | 0.8 | 1.420 | 1.5 | 1.052 | 1.1 | 1.767 | 1.9 |
| 6 | 90 | 139.02 | 2.080 | 1.5 | 0.815 | 0.6 | 2.234 | 1.6 | 1.839 | 1.3 | 2.893 | 2.1 |
| Control 1 | 90 | 14.32 | 0.162 | 1.1 | 0.196 | 1.4 | 0.254 | 1.8 | 0.320 | 2.2 | 0.409 | 2.9 |
| Control 2 | 90 | 71.50 | 1.024 | 1.4 | 1.244 | 1.7 | 1.611 | 2.3 | 1.232 | 1.7 | 2.028 | 2.8 | -
Within Run CV limits: low 9.0%, middle 4.5%, high 3.8%. Total Precision CV limits: low 12.0%, middle 6.0%, high 5.0%. Results are within specifications.
-
Lot to Lot variability: 3x5x2x3 study. Study materials: Yumizen C1200 Level 1 Protein Control, Yumizen C1200 Level 2 Protein Control, Pooled human sera.
-
Three reagent lots, one instrument system, 2 controls and 6 samples tested in triplicate for 5 days, two series per day. Calibrations done at the beginning of the study.
-
Results:
| Sample | N | Mean (mg/L) | SD | %CV (Within-run) | SD | %CV (Between-day) | SD | %CV (Within-lot) | SD | %CV (Between-lot) | SD | %CV (Total) |
|-----------|----|-------------|-------|------------------|-------|-------------------|-------|------------------|-------|-------------------|-------|-------------|
| 1 | 90 | 5.21 | 0.056 | 1.1 | 0.064 | 1.2 | 0.085 | 1.6 | 0.080 | 1.5 | 0.117 | 2.2 |
| 2 | 90 | 9.74 | 0.119 | 1.2 | 0.019 | 0.2 | 0.120 | 1.2 | 0.178 | 1.8 | 0.215 | 2.2 |
| 3 | 90 | 24.70 | 0.273 | 1.1 | 0.207 | 0.8 | 0.343 | 1.4 | 0.273 | 1.1 | 0.438 | 1.8 |
| 4 | 90 | 71.70 | 0.701 | 1.0 | 1.143 | 1.6 | 1.341 | 1.9 | 1.493 | 2.1 | 2.007 | 2.8 |
| 5 | 90 | 95.65 | 0.939 | 1.0 | 1.236 | 1.3 | 1.552 | 1.6 | 0.603 | 0.6 | 1.665 | 1.7 |
| 6 | 90 | 139.38 | 1.833 | 1.3 | 1.588 | 1.1 | 2.425 | 1.7 | 1.177 | 0.8 | 2.696 | 1.9 |
| Control 1 | 90 | 13.95 | 0.126 | 0.9 | 0.187 | 1.3 | 0.226 | 1.6 | 0.112 | 0.8 | 0.252 | 1.8 |
| Control 2 | 90 | 72.78 | 0.974 | 1.3 | 1.025 | 1.4 | 1.414 | 1.9 | 1.268 | 1.7 | 1.899 | 2.6 | -
Within Run CV limits: low 9.0%, middle 4.5%, high 3.8% for serum. Total Precision CV limits: low 12.0%, middle 6.0%, high 5.0% for serum. Results are within specifications.
Interferences (CLSI guideline EP07-A2)
- Study materials: Pooled Human sera. Substances added to base sera at two CRP concentrations (normal and high). Serially diluted with same base sera for which same volume of diluent added instead of substance.
- Acceptable bias +/-10% of value without interfering substances.
- Results show highest values for which no interferences higher than 10% were observed for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen, Erythromycin, Gentamycin, Ampicillin, Prednisone, Methotrexate, Etanercept, Simvastatin, Omeprazole, and Rheumatoid Factor (Up to 400 IU/mL).
Exogenous interferences - Study of the coagulation effect on the CRP assay Matrix comparison
- Study materials: Anticoagulant: heparin-lithium. Samples: 38 individual donors from blood bank.
- Each paired sample (sera and heparinized plasma) obtained from single donor. Only native samples used.
- Results: For 38 samples, range 5.09–133.86 mg/L, Slope 0.9398 (95%CI: 0.8973 – 1.007), Intercept 0.3413 (95% CI: -0.1611 – +0.6459), R 0.996.
- Conclusion: No significant difference between serum and plasma with heparin specimens. Coagulation does not have an impact on CRP determination.
Method comparison with a comparator device (NCCLS (CLSI) EP-9A3 guidance)
- Study materials: Anonymous remnants of human serum specimens from routine clinical laboratory.
- 102 native samples assayed in duplicate, in ascendant and descendant order on 6 working days. Only first replicate of each method used for data analysis.
- Passing Bablok Regression:
| Sample (N) | Range (mg/L) | Slope (95%CI) | Intercept (95% CI) | R2 |
|------------|--------------|---------------------------|-----------------------------|-------|
| 102 | 5.25–144.48 | 0.9814 (0.9680 – 0.9976) | 0.1305 (-0.1357 – +0.6287) | 0.998 |
Reagent Stability (CLSI guideline EP25-A)
- Closed stability: Shelf Life of Yumizen C1200 CRP is 24 months, stable up to expiry date on label if stored at 2-10°C.
- Open stability: On-board reagent stability is 8 weeks.
Reference range (CLSI guideline EP28-A3)
- 80 "normal samples" from blood bank assayed in duplicates. Mean of duplicate results compared against reference ranges in literature.
- Adults: 20-60 years
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
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June 25, 2020
Horiba ABX SAS Caroline Ferrer Regulatory Affairs Manager Parc Euromedecine, Rue du Caducee BP7290 Montpellier Cedex 4, 34184France
Re: K192028
Trade/Device Name: Yumizen C1200 CRP Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: July 25, 2019 Received: July 26, 2019
Dear Caroline Ferrer:
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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying (Katelin) Mao, Ph.D. Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K 192028
Device Name Yumizen C1200 CRP
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K192028 Yumizen C1200 Reagents
SECTION 007 : 510(k) Summary of K192028
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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K192028 Yumizen C1200 Reagents
- 1- Date of Summary Date submitted :25th June, 2020
2- Company
HORIBA ABX SAS HORIBA MEDICAL Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 France
3- Contact person
Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com) Telephone: + (33) 4 67 14 1843 Fax: + (33) 4 67 14 1517
4- Product Name
Yumizen C1200 CRP (1300023877)
5- Device Name and Classification
. Intended use
The devices involved by the 510(k) submission file are the following:
. Classification and Description
| Device's names | Intended Use |
|---|---|
| Yumizen C1200 | |
| CRP | Yumizen C1200 CRP reagent is intended for the quantitative in vitro |
| diagnostic determination of the C-reactive protein in human serum and | |
| lithium heparin plasma based 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. |
| Trade/Proprietary Name: | Yumizen C1200 CRP |
|---|---|
| Device Class: | Class II / 510(k) required |
| Classification Name: | §866.5270: C-reactive protein immunological test system |
| Product Code: | DCK |
| Panel: | Immunology (82) |
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K192028 Yumizen C1200 Reagents
- In this submission, HORIBA Medical presents Yumizen C1200 CRP with the Conventional application.
- Predicate: K142993 : QuickRead go CRP on QuickRead go CRP Analyzer / Orion Diagnostica, Oy
Comparator : K051564 : CRP reagent model : CRP LATEX REAGENT OSR6199 ● on Olympus AU400 Clinical Chemistry Analyzer / BECKMAN COULTER
- This submission allows to evaluate the functionality of the Yumizen C1200 analyzer for immunology analytes (ie.immunoturbidimetry).
6- Substantial Equivalence Information
The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below.
a. Predicate Device Name and 510(k) number
| Candidate device | Predicate device | Predicate Manufacturer | Predicate
510(k)
number |
|-------------------|------------------|------------------------|-------------------------------|
| Yumizen C1200 CRP | QuickRead go CRP | Orion Diagnostica, Oy | K142993 |
The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below.
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b. Yumizen C1200 CRP
Conventional method
i. Comparison with predicate Device : Similarities
| Device & Predicate Device(s) : | Predicate K142993 | Candidate K192028 |
|---|---|---|
| Device Trade Name | QuikRead Go CRP | Yumizen C1200 CRP (1300023877) |
| Intended Use | The QuikRead go CRP test is an | |
| immunoturbidimetric assay for the in vitro | ||
| quantitative determination of C-reactive | ||
| protein (CRP) in K2-EDTA and lithium | ||
| heparin whole blood, K2-EDTA and | ||
| lithium heparin plasma and in serum | ||
| samples. | ||
| The test is carried out by means of the | ||
| QuikRead go instrument. Measurement of | ||
| C-reactive protein aids in the evaluation of | ||
| injury to body tissues, and infection and | ||
| inflammatory disorders. The instrument | ||
| and assay are for use by trained | ||
| professionals in the clinical laboratory. For | ||
| in vitro diagnostic use only. | ||
| Not for point-of-care use. | Yumizen C1200 CRP reagent is | |
| intended for the quantitative in vitro | ||
| diagnostic determination of the C- | ||
| reactive protein in human serum and | ||
| lithium heparin plasma based 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. | ||
| Technology | Immunoturbidimetry | Same |
| Assay Type | Quantitative | Same |
| Analyte | C-reactive protein | Same |
| Product Code | DCK | Same |
| Reference Range | Results : |
| | Limit of
detection | Limit of
quantitation | Linearity Evaluated | Measuring range |
|----------------------------|-----------------------|--------------------------|----------------------|------------------|
| Serum | 0.23 mg/L | 5 mg/L | 9.42 to 150.78 mg/L. | 5.0 to 160 mg/L, |
| Serum
Post-
dilution | NA | NA | up to 737.40 mg/L | until 800 mg/L |
With Linearity – range 9.42 – 150.78 mg/L
| Range (mg/L) | Slope
(95%CI) | Intercept
(95% CI) | R2 |
|---------------|--------------------------|--------------------------|--------|
| 9.42 - 150.78 | 1.026
(1.005 – 1.047) | -1.33
(-3.23 – +0.58) | 0.9972 |
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9.2 Accuracy and Precision
Standards Followed CLSI document, EP5-A3
-
. Total Precision : 20x2x2
Study materials : -
Yumizen C1200 Level 1 Protein Control ı
-
i Yumizen C1200 Level 2 Protein Control
-
i Pooled human sera, anonymous remnants of human sera specimens collected from routine clinical laboratory.
Description of Test Procedure/Method
This evaluation was performed using 3 analyzers using 3 reagent lot.
The dedicated controls and 5 specimens covering the measuring range (low, medium and high) were tested in duplicate for 20 days, two series per day.
Within run : CV limits, for the low, middle and high level are respectively 9.0 %, 4.5 % and 3.8 %. Total precision: CV limits, for the low, middle and high level are respectively 12.0 %, 6.0 % and 5.0 %.
| Sample | N | Mean
(mg/L) | | Within-run | | Between-run | | Between-day | Between-
instrument | | | Total |
|-----------|-----|----------------|-------|------------|-------|-------------|-------|-------------|------------------------|-----|-------|-------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 240 | 5.06 | 0.042 | 0.8 | 0.053 | 1.0 | 0.125 | 2.5 | 0.037 | 0.7 | 0.147 | 2.9 |
| 2 | 240 | 9.79 | 0.075 | 0.8 | 0.075 | 0.8 | 0.083 | 0.8 | 0.052 | 0.5 | 0.144 | 1.5 |
| 3 | 240 | 27.61 | 0.208 | 0.8 | 0.388 | 1.4 | 0.629 | 2.3 | 0.000 | 0.0 | 0.768 | 2.8 |
| 4 | 240 | 65.33 | 0.597 | 0.9 | 0.582 | 0.9 | 0.921 | 1.4 | 0.303 | 0.5 | 1.279 | 2.0 |
| 5 | 240 | 141.27 | 2.546 | 1.8 | 0.000 | 0.0 | 2.372 | 1.7 | 0.976 | 0.7 | 3.614 | 2.6 |
| Control 1 | 240 | 16.57 | 0.130 | 0.8 | 0.235 | 1.4 | 0.338 | 2.0 | 0.000 | 0.0 | 0.432 | 2.6 |
| Control 2 | 240 | 74.88 | 0.637 | 0.9 | 0.888 | 1.2 | 0.847 | 1.1 | 0.567 | 0.8 | 1.494 | 2.0 |
The results are within the specifications.
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- Instrument variability : 3x5x2x3 ●
- Yumizen C1200 Level 1 Protein Control Study materials: - Yumizen C1200 Level 2 Protein Control - Pooled human sera, anonymous remnants of human sera specimens collected
from routine clinical laboratory
Description of Test Procedure/Method
The experimental is:
- One reagent lot -
- -Three instruments systems
- -2 controls and 6 samples tested in triplicate for 5 days, two series per day.
- -Calibrations are done at the beginning of the study.
Within Run : CV limits, for the low, middle and high level are respectively 9.0 %, 4.5 % and 3.8 % Total Precision : CV limits, for the low, middle and high level are respectively 12.0 %, 6.0 % and 5.0 %.
| Sample | N | Mean
(mg/L) | Within-day | | Between-day | | Within-
instrument | | Between-
instrument | | Total | |
|-----------|----|----------------|------------|-----|-------------|-----|-----------------------|-----|------------------------|-----|-------|-----|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 90 | 5.16 | 0.055 | 1.1 | 0.066 | 1.3 | 0.086 | 1.7 | 0.104 | 2.0 | 0.135 | 2.6 |
| 2 | 90 | 9.80 | 0.085 | 0.9 | 0.049 | 0.5 | 0.098 | 1.0 | 0.094 | 1.0 | 0.136 | 1.4 |
| 3 | 90 | 25.44 | 0.268 | 1.1 | 0.174 | 0.7 | 0.319 | 1.3 | 0.653 | 2.6 | 0.727 | 2.9 |
| 4 | 90 | 71.28 | 0.944 | 1.3 | 1.078 | 1.5 | 1.433 | 2.0 | 0.884 | 1.2 | 1.683 | 2.4 |
| 5 | 90 | 94.77 | 1.227 | 1.3 | 0.714 | 0.8 | 1.420 | 1.5 | 1.052 | 1.1 | 1.767 | 1.9 |
| 6 | 90 | 139.02 | 2.080 | 1.5 | 0.815 | 0.6 | 2.234 | 1.6 | 1.839 | 1.3 | 2.893 | 2.1 |
| Control 1 | 90 | 14.32 | 0.162 | 1.1 | 0.196 | 1.4 | 0.254 | 1.8 | 0.320 | 2.2 | 0.409 | 2.9 |
| Control 2 | 90 | 71.50 | 1.024 | 1.4 | 1.244 | 1.7 | 1.611 | 2.3 | 1.232 | 1.7 | 2.028 | 2.8 |
The results are within the specifications.
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- Lot to Lot variability : 3x5x2x3 .
Study materials: - Yumizen C1200 Level 1 Protein Control
-
Yumizen C1200 Level 2 Protein Control
-
Pooled human sera, anonymous remnants of human sera specimens collected from routine clinical laboratory
Description of Test Procedure/Method The experimental is:
- -Three reagent lot
- -One instrument system
- -2 controls and 6 samples tested in triplicate for 5 days, two series per day.
- -Calibrations are done at the beginning of the study.
Within Run : CV limits, for the low, middle and high level are respectively 9.0 %, 4.5 % and 3.8 % for serum
Total Precision : CV limits, for the low, middle and high level are respectively 12.0 %, 6.0 % and 5.0 % for serum.
| Sample | N | Mean
(mg/L) | | Within-run | | Between-day | | Within-lot | | Between-lot | | Total |
|-----------|----|----------------|-------|------------|-------|-------------|-------|------------|-------|-------------|-------|-------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 90 | 5.21 | 0.056 | 1.1 | 0.064 | 1.2 | 0.085 | 1.6 | 0.080 | 1.5 | 0.117 | 2.2 |
| 2 | 90 | 9.74 | 0.119 | 1.2 | 0.019 | 0.2 | 0.120 | 1.2 | 0.178 | 1.8 | 0.215 | 2.2 |
| 3 | 90 | 24.70 | 0.273 | 1.1 | 0.207 | 0.8 | 0.343 | 1.4 | 0.273 | 1.1 | 0.438 | 1.8 |
| 4 | 90 | 71.70 | 0.701 | 1.0 | 1.143 | 1.6 | 1.341 | 1.9 | 1.493 | 2.1 | 2.007 | 2.8 |
| 5 | 90 | 95.65 | 0.939 | 1.0 | 1.236 | 1.3 | 1.552 | 1.6 | 0.603 | 0.6 | 1.665 | 1.7 |
| 6 | 90 | 139.38 | 1.833 | 1.3 | 1.588 | 1.1 | 2.425 | 1.7 | 1.177 | 0.8 | 2.696 | 1.9 |
| Control 1 | 90 | 13.95 | 0.126 | 0.9 | 0.187 | 1.3 | 0.226 | 1.6 | 0.112 | 0.8 | 0.252 | 1.8 |
| Control 2 | 90 | 72.78 | 0.974 | 1.3 | 1.025 | 1.4 | 1.414 | 1.9 | 1.268 | 1.7 | 1.899 | 2.6 |
The results are within the specifications.
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9.3 Interferences
The Interferences were determined according to the CLSI guideline EP07-A2.
Study of the interferences from the hemolysis, triglycerides, icteria (total and direct bilirubin) samples and from Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen, rheumatoid factor (RF), Erythromycin, Gentamycin, Ampicillin, Prednisone, Methotrexate, Etanercept, Simvastatin and Omeprazole on the CRP assay with the Yumizen C1200 CRP reagent on the Yumizen C1200.
Description of Test Procedure/Method
Study materials: Pooled Human sera. Substances were added to the base sera at two different CRP concentrations (normal and high). The base sera with each substance was then serially diluted with the same base sera for which same volume of diluent was added instead of substance to adjust CRP concentration.
The acceptable bias is defined at +/-10% of the value without interfering substances.
These data in the following table represent the highest values for which no interferences higher than 10% have been observed.
| Serum | ||
|---|---|---|
| Hemoglobin | 290 µmol/L | 500 mg/dL |
| Triglycerides | 5.77 mmol/L | 504 mg/dL |
| Total Bilirubin | 607 µmol/ | 35.53 mg/dL |
| Direct Bilirubin | 393 µmol/L | 22.97 mg/dL |
| Ascorbic Acid | 340 µmol/L | 5.98 mg/dL |
| Acetylsalicylic | ||
| Acid | 3.62 mmol/L | 65.16 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 µmol/L | 20 mg/dL |
| Erythromycin | 200 µmol/L | 14.71 mg/dL |
| Gentamycin | 65 µmol/L | 3.11 mg/dL |
| Ampicillin | 250 µmol/L | 8.7 mg/dL |
| Prednisone | 0.500 µmol/L | 0.018 mg/dL |
| Methotrexate | 3000 µmol/L | 136 mg/dL |
| Etanercept | 0.05 µmol/L | 0.75 mg/dL |
| Simvastatin | 5 µmol/L | 0.21 mg/dL |
| Omeprazole | 25 µmol/L | 0.86 mg/dL |
| Rheumatoid | ||
| Factor | Up to 400 IU/mL |
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9.4 Exogenous interferences- Study of the coagulation effect on the CRP assay Matrix comparison
Study materials : Anticoagulant : heparin-lithium Samples: individual donors from blood bank
Description:
38 samples were evaluated on Yumizen C1200 analyser using Yumizen C1200 CRP reagent. For this study, each paired samples (sera and heparinized plasma) has been obtained from single donor.
Only native samples have been used for this study.
| Sample (N) | Range (mg/L) | Slope
(95%CI) | Intercept
(95% CI) | R |
|------------|--------------|----------------------------|-------------------------------|-------|
| 38 | 5.09–133.86 | 0.9398
(0.8973 – 1.007) | 0.3413
(-0.1611 – +0.6459) | 0.996 |
Conclusion :
The results show there is not significative difference between serum and plasma with heparin specimens
-> coagulation does not have an impact on CRP determination.
9.5 Method comparison with a comparator device
Study materials :
Samples: Anonymous remnants of human serum specimens collected from routine clinical laboratory.
Description:
This study has been carried out using recommendations found in the NCCLS (CLSI) EP-9A3 guidance.
These samples are in the candidate measuring range and comparator measuring range.
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102 native samples have been assayed in duplicate, in ascendant order and descendant order on 6 working days.
Only the first replicate of each method will be used for the data analysis reported below. The equation for the regression line using Passing Bablok was obtained.
Passing Bablok
| Sample (N) | Range
(mg/L) | Slope
(95%CI) | Intercept
(95% CI) | R2 |
|------------|-----------------|-----------------------------|-------------------------------|-------|
| 102 | 5.25–144.48 | 0.9814
(0.9680 – 0.9976) | 0.1305
(-0.1357 – +0.6287) | 0.998 |
9.6 Reagent Stability
8.6.1. Closed stability
The closed stability was determined according to the CLSI guideline EP25-A.
Stability before opening: Stable up to the expiry date on the label if stored at 2-10°C.
● CRP
The Shelf Life of Yumizen C1200 CRP is 24 months.
8.6.2 Open stability
The open stability was determined according to the CLSI guideline EP25-A.
On board reagent Stability:
The stability claim after opening, on-Board, is 8 weeks.
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9.7 Reference range
The Reference Range was determined according to the CLSI guideline EP28-A3.
- CRP
Serum
- A Adults data
80 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates.
The mean of the duplicate results for each subject was compared against reference ranges cited in literature. The verification studies support in the following reference ranges which were established through literature.
Adults: 20-60 years