(70 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for CRP, which is a chemical reaction-based measurement. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical metrics like precision, accuracy, and linearity, not on the performance of an AI/ML algorithm.
No
This device is an in vitro diagnostic (IVD) reagent used for the quantitative determination of C-reactive protein (CRP) in human samples, which helps in evaluating inflammation. It does not provide any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "quantitative in vitro diagnostic determination" of C-reactive protein, which is used to "evaluate conditions thought to be associated with inflammation." This directly aligns with the definition of a diagnostic device.
No
The device is a reagent for an in vitro diagnostic test, which is a chemical substance used in a laboratory setting to detect or measure a specific substance in a biological sample. This is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the 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". The phrase "in vitro diagnostic determination" is a clear indicator of an IVD.
- Device Description: The device description reiterates the intended use, again using the term "in vitro diagnostic determination".
- Performance Studies: The document details performance studies conducted on human serum and plasma samples, which is typical for an IVD used to analyze biological specimens.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K160712) is a strong indication that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DCK
Device Description
Not Found
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
Not Found
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. The reagent linearity was determined according to CLSI guideline EP06-A.
- Results: Serum: Limit of detection 0.13 mg/L, Limit of quantitation 0.16 mg/L, Linearity 0.03 to 11.53 mg/L, Measuring range 0.2 to 10 mg/L. For hsCRP with 1:5 dilution, the EMI is 10-50 mg/L.
Accuracy and Precision:
-
Repeatability (within-run precision) and Reproducibility (total precision) Serum samples.
- 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 %.
- Results with calibration every week (previous study):
- Low CRP Control: Mean(mg/L) 1.50, Total(%CV) 3.0
- Sample 1: Mean(mg/L) 0.34, Total(%CV) 5.9
- Sample 2: Mean(mg/L) 0.83, Total(%CV) 3.8
- Sample 3: Mean(mg/L) 4.13, Total(%CV) 3.1
- Sample 4: Mean(mg/L) 8.73, Total(%CV) 3.1
- Results with calibration only at the beginning of the study (new study):
- Low CRP Control: Mean(mg/L) 1.50, Total(%CV) 2.0
- Sample 1: Mean(mg/L) 0.39, Total(%CV) 6.2
- Sample 2: Mean(mg/L) 1.27, Total(%CV) 4.6
- Sample 3: Mean(mg/L) 3.00, Total(%CV) 2.1
- Sample 4: Mean(mg/L) 8.81, Total(%CV) 2.4
- The results are within the specifications.
-
Repeatability (within-run precision) for Heparin-Lithium sample.
- Study materials: Anonymous remnants of human Heparin-Lithium specimens collected from routine clinical laboratory.
- Description: 6 specimens (sample low, mid, high) were tested 20 times in a single run for each sample.
- Within run: CV limits, for the low (1 mg/L), middle (5 mg/L) and high level (9 mg/L) are respectively 9.0 %, 4.5 % and 3.8 %.
- Results:
- Sample 1 (N=20): Mean(mg/L) 0.35, Within-Run(%CV) 2.17
- Sample 2 (N=20): Mean(mg/L) 0.51, Within-Run(%CV) 2.11
- Sample 3 (N=20): Mean(mg/L) 1.25, Within-Run(%CV) 1.00
- Sample 4 (N=20): Mean(mg/L) 4.75, Within-Run(%CV) 2.27
- Sample 5 (N=20): Mean(mg/L) 7.77, Within-Run(%CV) 1.31
- Sample 6 (N=20): Mean(mg/L) 9.31, Within-Run(%CV) 0.69
- The results are within the specifications.
Interferences:
- The Interferences were determined according to the CLSI guideline EP07-A2. The acceptable bias is defined at +/-10% of the value without interfering substances.
- Results (highest values for no interference higher than 10%):
- Hemoglobin: 290 µmol/L (500 mg/dL)
- Triglycerides: 3.19 mmol/L (279 mg/dL)
- Total Bilirubin: 472 µmol/L (27.61 mg/dL)
- Direct Bilirubin: 520 µmol/L (30.41 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)
- Rheumatoid Factor: Up to 400 IU/mL
- Concerning Triglycerides Interferences: At 395 mg/dL triglycerides, there was a deviation of -11.2% per sample with 4.15 mg/L CRP, and at 517 mg/dL triglycerides, there was a deviation of -10.5% per sample with 0.83 mg/L CRP.
- Concerning Rheumatoid Factor Interferences: No significant influence is observed up to 400 IU/mL when tested at ~5 mg/L and ~9 mg/L CRP.
Matrix comparison serum vs heparin-lithium:
- Study materials: Individual donors from blood bank (in serum and plasma for each donor).
- Description of Test Procedure/Method: 54 samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 CRP reagent. Each sample came from a single donor, collected in both serum and heparin-lithium tube.
- Results (Passing Bablok): N=54, Min=0.210 mg/L, Max=9.180 mg/L, Intercept=-0.003012, Slope=0.9787, Correlation=0.998.
- Conclusion: The results show there is no significant difference between Serum and Heparin-Lithium specimens for the method in evaluation.
Method comparison with a comparator device:
- Comparator: Study carried out using recommendations from NCCLS (CLSI) EP-9A3guidance.
- Samples: Anonymous remnants of human serum specimens from routine clinical laboratory, within candidate and comparator measuring range.
- Description: 138 native samples assayed in duplicate, in ascendant and descendant order on 6 working days.
- Results (Passing Bablok regression line equation): N=138, Min=0.200 mg/L, Max=9.570 mg/L, Intercept=-0.06852, Slope=0.9987, Correlation - r²=0.995.
Reagent Stability:
- Closed stability: Determined according to CLSI guideline EP25-A. Stable up to expiry date on the label if stored at 2-10°C. Shelf Life of Yumizen C1200 CRP is 24 months.
- Open stability: Determined according to CLSI guideline EP25-A. On-Board stability is 8 weeks.
Reference range:
- Serum / Plasma:
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol is a stylized representation of human services. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2019
Horiba ABX SAS Caroline Ferrer Regulatory Affairs Manager Parc Euromédecine, Rue du Caducée - BP7290 34184 Montpellier Cedex 4 France
Re: K191993
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 24, 2019 Received: July 25, 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
1
cies. You must comply with all the Act's
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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,
For: Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology 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) K191993
Device Name Yumizen C1200 CRP
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for HORIBA Medical in blue text. Below the logo is the text "Section 007. 510(k) summary" in a gray font. The text appears to be part of a document or presentation.
SECTION 007: 510(k) Summary
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.
510(k) Number : K191993
4
Image /page/4/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a smaller font size compared to the logo. The overall layout is simple and professional.
- 1- Date of Summary Date submitted : 25th September, 2019
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
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 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. |
| 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) |
5
Image /page/5/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a light gray font. The image is simple and contains only text and a logo.
- In this submission, HORIBA Medical presents Yumizen C1200 CRP with the High sensitive ● application.
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 | VITROS Chemistry Products
hsCRP Reagent | Ortho-Clinical Diagnostics,
Inc. | K160712 |
The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below.
6
Image /page/6/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a smaller font size than the logo. The background of the image is white.
b. Yumizen C1200 CRP
i. Comparison with predicate Device : Similarities
| Item | Predicate K160712 | Candidate |
|---|---|---|
| Device Name | VITROS Chemistry Products hsCRP | |
| Reagent | Yumizen C1200 CRP | |
| Intended Use | VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure C-reactive protein (CRP) in human serum and plasma. 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. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals. |
| Reagent format | Liquid | Same |
| Method | Immunoturbidimetry | Same |
| Measurement | Quantitative | Same |
| Product code | DCK | DCK |
| Sample type | Serum, | |
| and Lithium heparin plasma | Serum, | |
| and Lithium heparin plasma |
7
Image /page/7/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a gray font and is left-aligned.
| Item | Predicate K160712 | Candidate |
|---|---|---|
| Device Name | VITROS Chemistry Products hsCRP | |
| Reagent | Yumizen C1200 CRP | |
| Instrument | VITROS 4,1 FS/4600 Chemistry | Yumizen C1200 Clinical chemistry |
| Analyzer | ||
| Manufactured by | Ortho-Clinical Diagnostics, Inc. | HORIBA ABX SAS |
| Calibrators | VITROS Chemistry Products Calibrator | |
| Kit 17 | ||
| VITROS Chemistry Products FS | ||
| Calibrator 1 | ||
| VITROS Chemistry Products FS Diluent | ||
| Pack 2 (BSA/Saline) (for calibration only) | Yumizen C1200 CRPhs Cal | |
| (1300071246) | ||
| Controls | VITROS Chemistry Products hsCRP | |
| Performance Verifier I, II and III | Yumizen C1200 Level 1 CRPhs Control | |
| (1300071247) | ||
| Yumizen C1200 Level 2 CRPhs Control | ||
| (1300071248) | ||
| Analytical Range | 0.10 to 15.00 mg/L | 0.2 to 10 mg/L |
| Reagent | ||
| On board Stability | ≤ 4 weeks | 8 weeks |
| Shelf-life | Stable until the expiration date printed on | |
| the label when stored at 2-8°C | Stable up to expiry date on the label if | |
| stored at 2-10°C |
ii. Comparison with predicate Device: Differences
- Calibrators&Controls : Yumizen C1200 CRP uses Yumizen C1200 CRPhs Cal and 2 Levels of controls : Yumizen C1200 Level 1 CRPhs Control and Yumizen C1200 Level 2 CRPhs Control.
on Yumizen C1200 whereas the predicate uses VITROS Chemistry Products calibrator Kit 17.
- Analytical range: The measuring range for Yumizen C1200 CRP is different.
Concerning low value, it is similar but slightly lower than the predicate value.
Concerning high value, it is lower than the predicate value.
8
Image /page/8/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter gray letters, is the word "Medical."
| Item | Predicate K160712 | Candidate |
|---|---|---|
| 4.On board stability: | The on board stability of Yumizen C1200CRP is longer. | |
| Stability depends on the reagent composition and cassette capacity. | ||
| 5.Shelf-life | Yumizen C1200 CRP has a reagent stability up to the expiration date when unopened and stored in 2-10°C. |
9
Image /page/9/Picture/0 description: The image shows the logo for HORIBA Medical in blue text. Below the logo is the text "Section 007. 510(k) summary" in a gray font. The text appears to be the title of a document or section within a document.
7- Special Control/Guidance Document Referenced
a. Standards Followed
The following standards & FDA guidance documents have been used to support this submission:
CLSI Guidelines:
- CLSI EP05-A3:Evaluation of Precision of Quantitative Measurement Procedures- Third Edition - October 2014
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement ● Procedures - Second Edition - June 2012
- CLSI EP09-A3: Measurement Procedure Comparison and Biais Estimation Using Patient ● Samples- Third Edition - August 2013
- . CLSI EP06-A: Evaluation of the Linearity of Quantitative measurement Procedures A Statistical Approach - First Edition - April 2003
- CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical ● laboratory- Third Edition - November 2008
- CLSI EP25-A : Evaluation of Stability of In Vitro Diagnostic reagents- First Edition-September 2009
b. FDA Guidances Followed
- Guidance for Industry and FDA Staff : Format for Traditional and Abbreviated 510(k)s - 2005
- Refuse To Accept (RTA) Policy for 510(k) - Guidance for Industry and Food and Drug Administration Staff - Document issued on: February 21, 2019.
- . Guidance for Industry and FDA Staff : eCopy Program for Medical Device Submissions -2015
- Guidance for Industry and FDA Staff : Review Criteria for Assessment of C-Reactive Protein ● (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP Assays) - Document issued on : September 22, 2005
c. Others Guidances followed
- Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745)
10
Image /page/10/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a smaller font size compared to the logo.
8- Analytical Performance Characteristics
8.1 Measuring Range
The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2. The reagent linearity was determined according to CLSI guideline EP06-A. The limit of quantitation and the linearity studies showed measuring range is appropriate.
≫ Results :
| | Limit of
detection | Limit of
quantitation | Linearity | Measuring range |
|-------|-----------------------|--------------------------|---------------------|-----------------|
| Serum | 0.13 mg/L | 0.16 mg/L | 0.03 to 11.53 mg/L. | 0.2 to 10 mg/L |
For hsCRP with 1:5 dilution, the EMI is 10-50 mg/L.
11
Image /page/11/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a simple, sans-serif font and appears to be part of a document or report.
8.2 Accuracy and Precision
- Repeatability (within-run precision) and Reproducibility (total precision) Serum samples .
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 %.
Results with calibration every week (previous study):
| Sample | N | Mean
(mg/L) | Within-Run
(%CV) | Between-Run
(%CV) | Between-Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|---------------------------------------|-----|----------------|---------------------|----------------------|----------------------|---------------------------------|----------------|
| Low CRP Control
(internal control) | 240 | 1.50 | 1.5 | 1.8 | 1.9 | 0.0 | 3.0 |
| Sample 1 | 240 | 0.34 | 4.7 | 2.8 | 2.3 | 0.1 | 5.9 |
| Sample 2 | 240 | 0.83 | 1.6 | 2.6 | 0.9 | 2.1 | 3.8 |
| Sample 3 | 240 | 4.13 | 0.6 | 1.7 | 1.7 | 1.9 | 3.1 |
| Sample 4 | 240 | 8.73 | 0.8 | 2.5 | 1.2 | 1.0 | 3.1 |
Results with calibration only at the beginning of the study (new study):
| Sample | N | Mean
(mg/L) | Within-Run
(%CV) | Between-Run
(%CV) | Between-Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|---------------------------------------|-----|----------------|---------------------|----------------------|----------------------|---------------------------------|----------------|
| Low CRP Control
(internal control) | 240 | 1.50 | 1.3 | 0.4 | 1.0 | 1.1 | 2.0 |
| Sample 1 | 240 | 0.39 | 4.8 | 0.0 | 1.6 | 3.7 | 6.2 |
| Sample 2 | 240 | 1.27 | 3.3 | 1.7 | 1.7 | 2.1 | 4.6 |
| Sample 3 | 240 | 3.00 | 1.3 | 1.4 | 0.7 | 0.6 | 2.1 |
| Sample 4 | 240 | 8.81 | 0.8 | 0.4 | 1.6 | 1.5 | 2.4 |
The results are within the specifications.
12
Image /page/12/Picture/0 description: The image shows the logo for HORIBA Medical in blue text. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be a section heading or title within a document.
- Repeatability (within-run precision) for Heparin-Lithium sample
Study materials:
Anonymous remnants of human Heparin-Lithium specimens collected from routine clinical laboratory.The within-run precision is performed using one lot of reagent, one instrument in a single run.
Description:
6 specimens (sample low, mid, high) were tested 20 times in a single run for each sample.
Within run : CV limits, for the low (1 mg/L), middle (5 mg/L) and high level (9 mg/L) are respectively 9.0 %, 4.5 % and 3.8 %.
| Sample | N | Mean
(mg/L) | Within-Run
(%CV) | SD
(mg/L) |
|----------|----|----------------|---------------------|--------------|
| Sample 1 | 20 | 0.35 | 2.17 | 0.01 |
| Sample 2 | 20 | 0.51 | 2.11 | 0.01 |
| Sample 3 | 20 | 1.25 | 1.00 | 0.01 |
| Sample 4 | 20 | 4.75 | 2.27 | 0.11 |
| Sample 5 | 20 | 7.77 | 1.31 | 0.10 |
| Sample 6 | 20 | 9.31 | 0.69 | 0.06 |
The results are within the specifications.
13
Image /page/13/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter letters, is the word "Medical."
8.3 Interferences
The Interferences were determined according to the CLSI guideline EP07-A2. 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 | 3.19 mmol/L | 279 mg/dL |
| Total Bilirubin | 472 µmol/ | 27.61 mg/dL |
| Direct Bilirubin | 520 µmol/L | 30.41 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 |
| Rheumatoid | ||
| Factor | Up to 400 IU/mL |
Concerning Triglycerides Interferences :
At 395 mg/dL triglycerides, there was a deviation of -11.2% per sample with a concentration of 4.15 mg/L CRP, and at 517 mg/dL triglycerides, there was a deviation of -10.5% per sample with a concentration of 0.83 mg/L CRP.
Concerning Rheumatoid Factor Interferences :
"No significant influence is observed up to 400 IU/mL when tested at ~5 mg/L and ~9 mg/L CRP."
This information is included in the reagent Instruction for use.
14
Image /page/14/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, the word "Medical" is in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name.
8.4 Matrix comparison
● Matrix comparison serum vs heparin-lithium on Yumizen C1200
Study materials :
Anticoagulant : heparin-lithium
Samples: individual donors from blood bank (in serum and plasma for each donor)
Description of Test Procedure/Method
54 samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 CRP reagent. For this study, each sample came from single donor. Samples was collected both in serum and heparin-lithium tube.
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
|---|---|---|---|---|---|---|
| CRP | ||||||
| (mg/L) | 54 | 0.210 | 9.180 | -0.003012 | 0.9787 | 0.998 |
Conclusion :
The results show there is no significant difference between Serum and Heparin-Lithium specimens for the method in evaluation.
15
Image /page/15/Picture/0 description: The image shows the logo for HORIBA Medical in blue font. Below the logo, the text "Section 007. 510(k) summary" is displayed in a smaller, gray font. The text appears to be part of a document or report.
8.5 _ Method comparison with a comparator device
Comparator :
This study has been carried out using recommendations found in the NCCLS (CLSI) EP-9A3guidance. Samples: Anonymous remnants of human serum specimens collected from routine clinical laboratory. These samples are in the candidate measuring range and comparator measuring range.
138 native samples have been assayed in duplicate, in ascendant order and descendant order on 6 working days.
The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation - r² |
|---|---|---|---|---|---|---|
| CRP (mg/L) | 138 | 0.200 | 9.570 | -0.06852 | 0.9987 | 0.995 |
16
Image /page/16/Picture/0 description: The image shows the logo for HORIBA Medical, with the word "HORIBA" in blue and "Medical" in a smaller font size below it. Below the logo, the text "Section 007. 510(k) summary" is displayed in a gray font. The text appears to be a section heading or title, possibly from a document or report.
8.6 Reagent Stability
Closed stability 8.2.1
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 correct at 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.
17
Image /page/17/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, light blue letters, is the word "Medical."
Traditional 510(k): Original Submission Yumizen C1200 Reagents