Who is the manufacturer of Yumizen C1200 CRP?

HORIBA ABX SAS filed the 510(k) submission for Yumizen C1200 CRP (K192028).

What is the FDA product code for Yumizen C1200 CRP?

DCK. It is classified under 21 CFR 866.5270 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for Yumizen C1200 CRP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Yumizen C1200 CRP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Yumizen C1200 CRP

K192028 · HORIBA ABX SAS · DCK · Jun 25, 2020 · Immunology

Device Facts

Record ID	K192028
Device Name	Yumizen C1200 CRP
Applicant	HORIBA ABX SAS
Product Code	DCK · Immunology
Decision Date	Jun 25, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended 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.

Device Story

Yumizen C1200 CRP is a latex-enhanced immunoturbidimetric assay for quantitative measurement of C-reactive protein (CRP) in human serum and lithium heparin plasma. The device uses a reagent kit containing a buffer solution and a 0.20% w/v suspension of latex particles sensitized with rabbit anti-CRP antibodies. When mixed with a patient sample, CRP antigens bind to the sensitized latex particles, causing agglutination. This reaction is detected as an absorbance change on the Yumizen C1200 Clinical Chemistry Analyzer; the magnitude of change is proportional to the CRP concentration. The analyzer calculates the final concentration by interpolating from a calibration curve. The device is intended for use in clinical laboratory settings by trained professionals. Results assist clinicians in evaluating tissue injury, infections, and inflammatory disorders in conjunction with other clinical findings. The system provides automated, quantitative results, facilitating rapid assessment of inflammatory states.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP05-A3, EP17-A2, EP06-A, EP07-A2, EP09-A3). Precision studies (20x2x2) showed total CVs ranging from 1.5% to 2.9%. Linearity confirmed across 9.42–150.78 mg/L (R2=0.9972). Method comparison against a comparator device (N=102) yielded a slope of 0.9814 and R2=0.998. Interference testing confirmed no significant bias (>10%) for common endogenous substances and drugs. No clinical data.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: Glycine buffer and 0.20% w/v latex suspension sensitized with rabbit anti-CRP antibodies. Measuring range: 5.0 to 160 mg/L (up to 800 mg/L with dilution). Connectivity: Integrated with Yumizen C1200 Clinical Chemistry Analyzer. Stability: 24-month shelf life; 8-week on-board stability. Standards: CLSI EP05-A3, EP17-A2, EP06-A, EP28-A3, EP25-A.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of C-reactive protein in human serum and lithium heparin plasma to aid in evaluating tissue injury, infections, and inflammatory disorders. For use by trained professionals in clinical laboratories.

Regulatory Classification

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.

Predicate Devices

QuickRead go CRP (K142993)

Reference Devices

CRP LATEX REAGENT OSR6199 on Olympus AU400 Clinical Chemistry Analyzer (K051564)

Related Devices

K191993 — Yumizen C1200 CRP · HORIBA ABX SAS · Oct 3, 2019
K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY · Stanbio Laboratory · Oct 14, 2004
K242170 — K-ASSAY CRP (Ver.2) · Kamiya Biomedical Company, LLC · Apr 18, 2025
K051564 — OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH · Olympus America, Inc. · Aug 22, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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) #### 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 contains the logo for HORIBA Medical. The word "HORIBA" is written in a large, bold, blue font. Below the word "HORIBA" is the word "Medical" written in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name. 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. {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 in a smaller font size. The text is likely a section heading or title within a document. 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) | {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 gray font and appears to be part of a document. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains 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. # 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 | < 5 mg/L* | Same | *20 to 60 years {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is written in large, bold, blue letters. Below it, the word "Medical" is written in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name. ## ii. Comparison with predicate Device: Differences | Device & Predicate Device(s) : | Predicate K142993 | Candidate K192028 | |-----------------------------------|---------------------------------------------------------------------------------|----------------------------------------------| | Device Trade Name | QuikRead Go CRP | Yumizen C1200 CRP (1300023877) | | Instrument | QuikRead go Analyzer | Yumizen C1200 Clinical chemistry Analyzer | | Test | Microparticles | Latex particles | | Antibody | Anti-human CRP F(ab)2 fragment | Rabbit anti-CRP antibodies | | Sample Type | serum, plasma (Li-Heparin, K2-EDTA), whole blood (Li-heparin, K2-EDTA) | Serum, lithium heparin plasma | | Analytical Measuring Range | 5 to 200 mg/L: serum and plasma 5 to150 mg/L: whole blood | 5 to 160 mg/L | | Traceability | ERM-DA 474 | IRMM/ERM-DA472/IFCC | | Control | Control 1: ~30 mg/L Control 2: ~70 mg/L | Control 1: ~15 mg/L Control 2: ~80 mg/L | # 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 {8}------------------------------------------------ Image /page/8/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 appears to be part of a document. - CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures - Second Edition - June 2012 - 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 : 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. References Cited - Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745 ## 8- Device Description - Method 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. - Reagent : composition and Description Reagents Yumizen C1200 CRP is ready-to-use. Reagent 1: Buffer solution: Glycine buffer solution Reagent 2: {9}------------------------------------------------ Image /page/9/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. K192028 Yumizen C1200 Reagents 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. ## 9- Analytical Performance Characteristics #### 9.1 Measuring Range #### ● LOQ The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2. #### Description of Test Procedure/Method A range of low concentrations samples has been assayed following this conditions: - Two reagents lots - - One instrument system - - -Five days - -Five samples - Two run, four replicates per run per sample (for each reagent lot, each day) - - -1 technician {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo, the text "Section 007. 510(k) summary" is written in a light gray font. The text appears to be part of a document or report. Sample selection: Samples come from dilution of individual serum samples by commercial depleted serum. #### ● Linearity The reagent linearity was determined according to CLSI guideline EP06-A. Description: The linearity is evaluated using a range of samples, at different concentrations covering the desirable range, extended in the lowest and the highest ends. Each level has been assayed 3 times. The highest concentration sample used for this study is a pooled human sera sample spike with CRP stock solution. The limit of quantitation and the linearity studies showed that claimed measuring range is appropriate. - > 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 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below "HORIBA" is the word "Medical" in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name. ## 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. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in a smaller font and lighter blue color, is the word "Medical." - 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. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is written in large, bold, blue letters. Below the word "HORIBA" is the word "Medical" written in a smaller, lighter blue font. The logo is simple and clean, and the colors are consistent. - 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. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image contains 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". The logo is simple and clean, with a focus on the company name. ## 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 | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the HORIBA Medical logo. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, light blue letters, is the word "Medical." #### 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. {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "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. 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. {17}------------------------------------------------ Image /page/17/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below "HORIBA" is the word "Medical" in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name. #### 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 < 5 mg/L #### Reference.: Roberts WL, McMillin GA, Burtis CA, Bruns DE. Reference Information for the Clinical Laboratory, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics; 4th Ed., Burtis CA, Ashwood ER, Bruns DE (Elsevier Saunders eds., St Louis, USA), (2006): 2263. #### 9.8 Proposed Labeling The labeling is written as per the recommendations given in standard EN18113-2. It takes into account the requirements of 21 CFR Part 809.10. #### 9.9 Conclusions for Performance Testing The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that each device is substantially equivalent to its predicate device. {18}------------------------------------------------ Image /page/18/Picture/0 description: The image contains 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. Yumizen C1200 Reagents