← Product Code [DBF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF) · K191562 # Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562) _HORIBA ABX SAS · DBF · Mar 6, 2020 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K191562 ## Device Facts - **Applicant:** HORIBA ABX SAS - **Product Code:** [DBF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF.md) - **Decision Date:** Mar 6, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5340 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro diagnostic determination of ferritin in human serum by latex-enhanced immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, hemochromatosis (iron overload), and iron deficiency anemia. Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro diagnostic determination of transferrin in human serum and lithium heparin plasma by turbidimetry. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative in vitro diagnostic determination of rheumatoid factor in human serum by latex-enhanced immunoturbidimetric assay. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. ## Device Story Yumizen C1200 reagents are liquid, ready-to-use in vitro diagnostic assays for the Yumizen C1200 clinical chemistry analyzer. Ferritin and Rheumatoid Factor use latex-enhanced immunoturbidimetric methods; Transferrin uses turbidimetry. The analyzer processes human serum (or lithium heparin plasma for Transferrin) samples, measuring light absorbance changes to quantify analyte concentration. The system includes automated prozone detection to flag antigen excess and trigger automatic reruns. Results are provided to clinicians to assist in diagnosing iron metabolism disorders, anemia, malnutrition, and rheumatoid arthritis. The device is intended for professional use in clinical laboratory settings. ## Clinical Evidence No clinical studies were performed. Substantial equivalence is supported by analytical performance data, including precision (repeatability/reproducibility), linearity, limit of detection (LoB/LoD/LoQ), interference testing, and method comparison studies against predicate devices using clinical samples. Correlation coefficients (r) were 0.999 (Ferritin), 0.993 (Transferrin), and 0.992 (RF). ## Technological Characteristics Quantitative immunoturbidimetric assays. Ferritin/RF: latex-enhanced; Transferrin: standard turbidimetry. Reagents: liquid format, buffer solutions (Glycine or TRIS), and antibodies (rabbit anti-ferritin, goat anti-human transferrin, or denatured human IgG). Energy source: optical (turbidimeter). Connectivity: integrated with Yumizen C1200 analyzer. Traceability: NIBSC/WHO standards or ERM-DA470k/IFCC. ## Regulatory Identification A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia. ## Predicate Devices - Ferritin (OSR61203) ([K092505](/device/K092505.md)) - Transferrin Model: TRSF2 ([K012393](/device/K012393.md)) - Olympus RF Latex reagent (OSR61105) ([K060201](/device/K060201.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. March 6, 2020 Horiba ABX SAS Caroline Ferrer Regulatory Affairs Manager Parc Euromedecine, Rue Du Caducee BP 7290 Montpellier Cedex 4, 341184 France Re: K191562 Trade/Device Name: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, DDG, DHR Dated: June 11, 2019 Received: June 13, 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}------------------------------------------------ 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, Carolina Kagan, M.Sc. 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) k191562 Device Name Yumizen C1200 Ferritin Yumizen C1200 Transferrin Yumizen C1200 Rheumatoid Factor ### Indications for Use (Describe) Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro diagnostic determination of Ferritin in human serum by latex-enhanced immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, hemochromatosis (iron overload) and iron deficiency anemia. Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro diagnostic determination of transferrin in human serum and lithium heparin plasma by turbidimetry. Measurement of transferrin levels ads in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative in vitro diagnostic determination of rheumatoid factor in human serum by latex-enhanced immunoturbidimetric assay. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. Type of Use (Select one or both, as applicable) X 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 HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a gray font. The text appears to be part of a document or report. # 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo is the text "Section 007. 510(k) summary" in a gray font. The text appears to be a section heading or title, possibly from a document or report. - 1- Date of Summary Date submitted : 5th March, 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 Ferritin (1300023880) Yumizen C1200 Transferrin (1300023889) Yumizen C1200 Rheumatoid Factor (1300023888) ## 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
Ferritin | Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro
diagnostic determination of Ferritin in human serum by latex-enhanced
immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis
of diseases affecting iron metabolism, hemochromatosis (iron overload)
and iron deficiency anemia. | | Yumizen C1200
Transferrin | Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro
diagnostic determination of Transferrin in human serum and lithium
heparin plasma by turbidimetry.
Measurement of transferrin levels aids in the diagnosis of malnutrition,
acute inflammation, infection, and iron deficiency anemia. | | Yumizen C1200
Rheumatoid Factor | Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative
in vitro diagnostic determination of rheumatoid factor in human serum by
latex-enhanced immunoturbidimetric assay.
Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid
arthritis. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a gray font. The text appears to be part of a document or report. | Trade/Proprietary Name: | Yumizen C1200 Ferritin | |-------------------------|--------------------------------------------------------| | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5340: Ferritin immunological test system | | Product Code: | DBF | | Panel: | Immunology (82) | | Trade/Proprietary Name: | Yumizen C1200 Transferrin | | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5880: Transferrin immunological test system | | Product Code: | DDG | | Panel: | Immunology (82) | | Trade/Proprietary Name: | Yumizen C1200 Rheumatoid Factor | | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5775: Rheumatoid factor immunological test system | | Product Code: | DHR | | Panel: | Immunology (82) | - . This submission allows to evaluate the functionality of the Yumizen C1200 analyzer for immunology analytes (ie.immunoturbidimetry). #### Substantial Equivalence Information 6- 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
Ferritin | Ferritin ( OSR61203) | BECKMAN COULTER | K092505 | | Yumizen C1200
Transferrin | Transferrin Model :TRSF2 | Roche Diagnostics | K012393 | | Yumizen C1200
Rheumatoid Factor | Olympus RF Latex reagent
(OSR61105) | Olympus America, Inc. | K060201 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the HORIBA Medical logo. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter blue letters, is the word "Medical." The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below. ## b. Yumizen C1200 Ferritin ## i. Comparison with predicate Device : Similarities | Item | Predicate K092505 | Candidate | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Ferritin (OSR61203) | Yumizen C1200 Ferritin (1300023880) | | Intended Use | The Ferritin Reagent is for the
determination of ferritin concentrations in
human serum and plasma on the Beckman
Coulter AU clinical chemistry analyzers.
Serum ferritin is an indicator of body iron
stores: it has been shown to correlate with
stainable bone marrow iron. Measurements
of ferritin aid in the diagnosis of diseases
affecting iron metabolism, such as
hemochromatosis (iron overload) and iron
deficiency anemia. | Yumizen C1200 Ferritin reagent is
intended for the quantitative in vitro
diagnostic determination of Ferritin in
human serum by latex-enhanced
immunoturbidimetric assay.
Measurements of ferritin aid in the
diagnosis of diseases affecting iron
metabolism, hemochromatosis (iron
overload) and iron deficiency anemia. | | Reagent format | Liquid | Same | | Measurement | Quantitative | Same | | Method | Latex-enhanced immuno-turbidimetric
method | Same | | Product code | DBF | Same | | On board Stability | Once opened, the reagent cassette placed
in the refrigerator compartment is stable
for 60 days | Once opened, the reagent cassette placed
in the refrigerator compartment is stable
for 2 months (or 60 days). | | Calibration
Stability | The frequency of calibration for the
Ferritin procedure is every
30 days | The reagent is calibrated on Day 0. The
calibration stability is checked by testing
2 control specimens.
The calibration stability is
1 month
(or 30 days) | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the HORIBA Medical logo 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, possibly from a document or report. | Item | Predicate K092505 | Candidate | |------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------| | Device Name | Ferritin (OSR61203) | Yumizen C1200 Ferritin (1300023880) | | Instrument | Beckman Coulter AU400 Clinical
Chemistry Analyzer | Yumizen C1200 Clinical chemistry
analyzer | | Manufactured by | BECKMAN COULTER | HORIBA ABX SAS | | Sample type | Serum,
Li-heparin plasma
and EDTA plasma samples | Serum | | Packaging | Cassette of :
R1= 4 x 24 mL
R2= 4 x 12 mL | Cassette of :
R1: 6 x 11 mL
R2: 6 x 7 mL | | Shelf-life | Unopened, up to the stated expiry date
when stored at 2-8°C. | Stable up to the expiration date if stored
at 2-10°C. | | Analytical Range | Measuring Range
$8.0 - 450.0$ ng/mL | Measuring Range
$10 - 450$ ng/mL | | Reference range | Women: $10 - 158$ ng/mL
Men: $16 - 243$ ng/mL | Adults :
Women: $10 - 120$ ng/mL ( $\mu$ g/L)
Men: $20 - 250$ ng/mL ( $\mu$ g/L) | ## ii. Comparison with predicate Device: Differences Discussion on the analysis differences : - 1. Instrument: Yumizen C1200 Ferritin is used on Yumizen C1200 - 2. Packaging: Packaging is different; depends on cassette capacity. - 3. Reagent stability/ Shelf-life:storage temperature is different. - 4. Analytical range: the measuring range for Yumizen C1200 Ferritin is slightly higher on the lower end - 5. Reference range: Yumizen C1200 Ferritin has tighter reference range on the upper end for Women and slightly larger reference range on the upper end for Men. - Sample type: Yumizen C1200 Ferritin uses serum. 6. {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 blue letters, is the word "Medical". There is also some text that appears to be a code or part number, "007-510(1)". ## c. Yumizen C1200 Transferrin (1300023889) ## i. Comparison with predicate Device : Similarities | Item | Predicate k012393 | Candidate | |------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Transferrin Model :TRSF2 | Yumizen C1200 Transferrin
(1300023889) | | Intended Use | In vitro test for the quantitative
determination of transferrin in human
serum and plasma in Roche/Hitachi cobas
c systems. | Yumizen C1200 Transferrin reagent is
intended for the quantitative in vitro
diagnostic determination of Transferrin
in human and lithium heparin plasma by
turbidimetry.
Measurement of transferrin levels aids in
the diagnosis of malnutrition, acute
inflammation, infection, and iron
deficiency anemia. | | Sample type | Serum
plasma | Serum
plasma | | Reagent format | Liquid | Same | | Measurement | Quantitative | Same | | Method | Turbidimetry | Same | | Product code | DDG | Same | | Shelf-life | 2-8°C,
See expiration date on label | Stable up to the expiry date on the label
if stored at 2-8°C. | | Analytical Range | Measuring Range
0.1-5.2 g/L | Measuring Range
0.10-5.20 g/L | | Reference range | 200-360 mg/dL | 200-360 mg/dL | {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, in smaller blue letters, is the word "Medical." k191562 Yumizen C1200 Reagents ## ii. Comparison with predicate Device: Differences | Item | Predicate k012393 | Candidate | |--------------------|-----------------------------|-------------------------------------------------------------------------------------------------------| | Device Name | Transferrin Model : TRSF2 | Yumizen C1200 Transferrin
(1300023889) | | Instrument | Roche analyzer (Cobas C701) | Yumizen C1200 Clinical chemistry
analyzer | | Manufactured by | ROCHE | HORIBA ABX SAS | | On board Stability | 4 weeks | Once opened, the reagent cassette placed
in the refrigerated compartment is stable
for 6 weeks. | Discussion on the analysis differences : 1. Instrument & Manufacturer: Yumizen C1200 Transferrin is used on Yumizen C1200. Yumizen C1200 Transferrin is manufactured by HORIBA ABX SAS. 2. Reagent stability: the on board stability of Yumizen C1200 Transferrin is longer. Stability depends on the reagent composition and cassette capacity. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for HORIBA Medical in blue font. 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 larger document. ## d. Yumizen C1200 Rheumatoid Factor | Item | Predicate K060201 | Candidate | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Rheumatoid Factor reagent model :
OSR61105 | Yumizen C1200 Rheumatoid Factor
(1300023888) | | Intended Use | Olympus RF Latex System reagent for the
quantitative determination of Rheumatoid
Factor (RF) in human serum and plasma
on Olympus AU analyzers.
Measurement of rheumatoid factor may
aid in the diagnosis of rheumatoid arthritis | Yumizen C1200 Rheumatoid Factor
reagent is intended for the quantitative in
vitro diagnostic determination of
rheumatoid factor in human serum by
latex-enhanced immunoturbidimetric
assay.
Measurement of rheumatoid factor may
aid in the diagnosis of rheumatoid
arthritis. | | Manufactured by | OLYMPUS AMERICA, INC | HORIBA ABX SAS | | Measurement | Quantitative | Quantitative | | Method | Latex-enhanced Immunoturbidimetry | Same | | Product code | DHR | Same | | Calibration
Stability | The frequency of calibration for the RF
Latex procedure is every 30 days. | The calibration stability is 1 month
(or 30 days) | | Reference range | Adult ≤ 14 IU/mL | Same | ## i. Comparison with predicate Device : Similarities {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a smaller, gray font. The text appears to be a section heading or title, possibly from a document or report. | Item | Predicate K060201 | Candidate | |------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Device Name | Rheumatoid Factor reagent model :
OSR61105 | Yumizen C1200 Rheumatoid Factor
(1300023888) | | Instrument | Olympus AU400 Clinical Chemistry
Analyzer | Yumizen C1200 Clinical chemistry
analyzer | | Sample type | Serum, plasma | Serum | | Reagent format | Liquid | Same | | Packaging | Cassette of :
R1= 4 x 24 mL
R2= 4 x 8mL | Cassette of :
R1: 6 x 13 mL
R2: 6 x 6 mL | | Analytical range | Measuring range :
5-120 IU/mL | Measuring range :
10 - 120 IU/mL | | Shelf-life | Until expiration date on label
(+2-8 °C) | Stable up to expiration date
if stored at 2-10°C | | On board Stability | Once opened, the reagent is stable
for 60 days in refrigerated compartment of
analyzer. | Once opened, the reagent cassette placed
in the refrigerator compartment is stable
for 1 month (or 30 days) | | Discussion on the analysis differences : | | | ## ii. Comparison with predicate Device: Differences 1. Instrument: Yumizen C1200 Rheumatoid Factor is used on Yumizen C1200 3. Packaging: Packaging is different; depends on cassette capacity. 4. Reagent stability: the on board stability Yumizen C1200 Rheumatoid Factor is shorter. The Shelf life is different. Stability depend on reagent composition and cassette capacity. 5.Analytical range: the measuring range for serum for Yumizen C1200 Rheumatoid factor is slightly tighter on the lower end 6. Sample type: Yumizen C1200 RF uses serum only. {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 the word "HORIBA" is the word "Medical" in a smaller, lighter blue font. The logo is simple and clean. k191562 Yumizen C1200 Reagents ### 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 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 ● ### c. Other reference cited - Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745) - CLSI EP09-A3 : Measurement Procedure Comparison and Bias Estimation Using Patient ● Samples - Third Edition - August 2013 {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo is the text "Section 007. 510(k) summary" in a light gray font. The text appears to be part of a document or report. ### 8- Analytical Performance Characteristics ### 8.1 Measuring Range #### Yumizen C1200 Ferritin ● 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 that claimed measuring range is appropriate. ### > Results : | | Limit of
detection | Limit of
quantitation | Linearity evaluated | Measuring range | |----------------------------|-----------------------|--------------------------|---------------------|------------------| | Serum | 6.30 ng/mL | 9.39 ng/mL | 13.3 - 426.6 ng/mL | 10 to 450 ng/mL | | Serum
Post-
dilution | NA | NA | NA | until 2250 ng/mL | #### ● Yumizen C1200 Transferrin 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 evaluated | Measuring range | |---------------------------------------|-----------------------|--------------------------|---------------------|------------------| | Serum/
Plasma | 0.002 g/L | 0.07 g/L | 0.15 - 4.61 g/L | 0.10 to 5.20 g/L | | Serum/
Plasma
Post-
dilution | NA | NA | NA | 15.60 until g/L | {14}------------------------------------------------ Image /page/14/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 smaller, gray font. The text appears to be a section heading or title, possibly from a document or report. #### Yumizen C1200 Rheumatoid Factor ● 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 that claimed measuring range is appropriate. ## 》 Results : | | Limit of detection | Limit of quantitation | Linearity evaluated | Measuring range | |------------------------|--------------------|-----------------------|---------------------|------------------| | Serum | 4.07 IU/mL | 7.41 IU/mL | 13.2 - 118.8 IU/mL | 10 to 120 IU/mL | | SerumPost
-dilution | NA | NA | NA | until 1200 IU/mL | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for HORIBA Medical, followed by the text "Section 007. 510(k) summary". The HORIBA logo is in blue, with the word "HORIBA" in a larger, bolder font than the word "Medical" below it. The text "Section 007. 510(k) summary" is in a smaller, gray font. ### 8.2 Accuracy and Precision Repeatability (within-run precision) and Reproducibility (total precision) #### Yumizen C1200 Ferritin ● #### A Total Precision : analyzer variability - 20x2x2 study Within Run : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0% and 6.0% for serum Total Precision : CV limits, for the low, middle and high level are respectively 10.0 %, 8.0 % for serum. | Sample | N | Mean
(ng/mL) | Within-Run
(%CV) | Between-Run
(%CV) | Between-Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) | |---------------------------------------------|-----|-----------------|---------------------|----------------------|----------------------|---------------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 240 | 47.58 | 3.6 | 0.0 | 1.5 | 3.1 | 4.9 | | Yumizen C1200
Level 2 Protein
Control | 240 | 279.31 | 1.1 | 0.0 | 1.6 | 0.8 | 2.1 | | Sample 1 | 240 | 29.56 | 5.5 | 2.2 | 2.2 | 4.7 | 7.9 | | Sample 2 | 240 | 50.87 | 4.1 | 1.9 | 0.0 | 2.4 | 5.1 | | Sample 3 | 240 | 172.63 | 1.4 | 0.3 | 0.6 | 1.1 | 1.9 | | Sample 4 | 240 | 328.60 | 1.3 | 3.6 | 2.0 | 0.0 | 4.3 | | Sample 5 | 240 | 403.21 | 1.0 | 0.6 | 0.6 | 0.4 | 1.4 | {16}------------------------------------------------ Image /page/16/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." - > Lot to Lot variability : 3x5x2x3 Within Run : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0 % and 6.0 % for serum Total Precision : CV limits, for the low, middle and high level are respectively 10.0 %, 8.0 % and 8.0 % for serum. | Sample | N | Mean
(ng/mL) | Within-
Run
(%CV) | Between-
Day (%CV) | Within-
Batch
(%CV) | Between-
Batch
(%CV) | Total
(%CV) | |---------------------------------------------|----|-----------------|-------------------------|-----------------------|---------------------------|----------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 90 | 52.84 | 4.6 | 4.5 | 6.4 | 0.0 | 6.4 | | Yumizen C1200
Level 2 Protein
Control | 90 | 281.87 | 0.9 | 0.7 | 1.1 | 1.2 | 1.6 | | Sample 1 | 90 | 19.09 | 8.8 | 4.8 | 10.0 | 6.3 | 11.8 | | Sample 2 | 90 | 34.05 | 6.5 | 0.0 | 6.5 | 0.5 | 6.5 | | Sample 3 | 90 | 51.53 | 3.6 | 0.0 | 3.6 | 1.1 | 3.8 | | Sample 4 | 90 | 192.31 | 1.4 | 0.0 | 1.4 | 2.5 | 2.8 | | Sample 5 | 90 | 407.38 | 0.9 | 0.0 | 0.9 | 1.0 | 1.4 | Although the %CV of Within Day and Total Precision are superior to the Acceptance criteria, the pvalue with 5% acceptable remains acceptable for sample 1. {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below the main logo. Below the logo is the text "Section 007. 510(k) summary" in a gray font. The text appears to be a section heading or title within a document. #### Yumizen C1200 Transferrin ● ## > Total Precision : analyzer variability - 20x2x2 study Within Run : CV limits, for the low, middle and high level are respectively 6.0 %, 4.5 % and 3.8 % for serum and plasma Total Precision : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0 % for serum and plasma. | Sample | N | Mean
(g/L) | Within-
Run
(%CV) | Between-
Run (%CV) | Between-
Day (%CV) | Between-
Instrument
(%CV) | Total
(%CV) | |---------------------------------------------|-----|---------------|-------------------------|-----------------------|-----------------------|---------------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 240 | 1.24 | 1.2 | 0.7 | 2.1 | 2.5 | 3.6 | | Yumizen C1200
Level 2 Protein
Control | 240 | 3.35 | 1.5 | 0.6 | 1.4 | 2.8 | 3.6 | | Sample 1 | 240 | 0.78 | 1.0 | 0.5 | 2.3 | 3.7 | 4.5 | | Sample 2 | 240 | 1.02 | 1.2 | 0.3 | 1.7 | 2.5 | 3.2 | | Sample 3 | 240 | 1.83 | 1.3 | 0.5 | 1.3 | 1.3 | 2.3 | | Sample 4 | 240 | 3.78 | 1.5 | 0.6 | 1.1 | 1.9 | 2.7 | {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, in smaller, lighter blue letters, is the word "Medical." ## ► Lot to Lot variability : 3x5x2x3 Within Run : CV limits, for the low, middle and high level are respectively 6.0 %, 4.5 % and 3.8 % for serum and plasma Total Precision : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0 % for serum and plasma. | Sample | N | Mean
(g/L) | Within-
Run
(%CV) | Between-
Day (%CV) | Within-
Batch
(%CV) | Between-
Batch
(%CV) | Total
(%CV) | |---------------------------------------------|----|---------------|-------------------------|-----------------------|---------------------------|----------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 90 | 1.29 | 3.5 | 5.3 | 6.3 | 1.7 | 6.6 | | Yumizen C1200
Level 2 Protein
Control | 90 | 3.41 | 1.7 | 1.2 | 2.1 | 2.2 | 3.0 | | Sample 1 | 90 | 0.77 | 4.2 | 2.7 | 5.0 | 2.0 | 5.4 | | Sample 2 | 90 | 1.08 | 1.5 | 0.9 | 1.7 | 2.8 | 3.3 | | Sample 3 | 90 | 1.96 | 1.3 | 0.2 | 1.3 | 3.2 | 3.4 | | Sample 4 | 90 | 3.54 | 2.6 | 0.7 | 2.7 | 2.1 | 3.4 | {19}------------------------------------------------ Image /page/19/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. #### Yumizen C1200 Rheumatoid Factor . ## > Total Precision : analyzer variability - 20x2x2 study Within Run : CV limits, for the low, middle and high level are respectively 6.0 %, 4.5 % and 3.8 % for serum Total Precision : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0 % for serum. | Sample | N | Mean
(IU/mL) | Within-
Run
(%CV) | Between-
Run (%CV) | Between-
Day (%CV) | Between-
Instrument
t (%CV) | Total
(%CV) | |---------------------------------------------|-----|-----------------|-------------------------|-----------------------|-----------------------|-----------------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 240 | 40.99 | 0.5 | 0.4 | 1.2 | 1.7 | 2.2 | | Yumizen C1200
Level 2 Protein
Control | 240 | 63.93 | 0.4 | 0.6 | 1.6 | 1.8 | 2.5 | | Sample 1 | 240 | 22.24 | 1.2 | 0.9 | 0.9 | 1.0 | 2.0 | | Sample 2 | 240 | 34.28 | 0.8 | 1.3 | 1.3 | 0.9 | 2.2 | | Sample 3 | 240 | 49.41 | 0.5 | 1.0 | 0.5 | 1.3 | 1.8 | | Sample 4 | 240 | 70.16 | 0.5 | 0.4 | 0.8 | 1.3 | 1.6 | | Sample 5 | 240 | 103.42 | 0.8 | 0.6 | 0.7 | 0.5 | 1.4 | {20}------------------------------------------------ Image /page/20/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." ## ► Lot to Lot variability : 3x5x2x3 Within Run : CV limits, for the low, middle and high level are respectively 6.0 %, 4.5 % and 3.8 % for serum Total Precision : CV limits, for the low, middle and high level are respectively 8.0 %, 6.0 % for serum. | Sample | N | Mean
(IU/mL) | Within-
Run
(%CV) | Between-
Day (%CV) | Within-
Batch
(%CV) | Between-
Batch
(%CV) | Total
(%CV) | |---------------------------------------------|----|-----------------|-------------------------|-----------------------|---------------------------|----------------------------|----------------| | Yumizen C1200
Level 1 Protein
Control | 90 | 41.70 | 1.8 | 0.3 | 1.8 | 0.6 | 1.9 | | Yumizen C1200
Level 2 Protein
Control | 90 | 67.05 | 1.4 | 0.5 | 1.5 | 1.6 | 2.2 | | Sample 1 | 90 | 17.30 | 2.9 | 0.7 | 3.0 | 0.8 | 3.1 | | Sample 2 | 90 | 30.88 | 1.4 | 0.6 | 1.6 | 0.9 | 1.8 | | Sample 3 | 90 | 53.08 | 1.4 | 0.9 | 1.6 | 2.7 | 3.2 | | Sample 4 | 90 | 70.24 | 1.1 | 0.8 | 1.3 | 0.0 | 1.3 | | Sample 5 | 90 | 102.14 | 1.0 | 0.4 | 1.1 | 1.4 | 1.8 | {21}------------------------------------------------ Image /page/21/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. ## 8.3 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. #### Yumizen C1200 Ferritin ● | Serum | | | |-------------------------|-------------|--------------| | Hemoglobin | 290 µmol/L | 500 mg/dL | | Triglycerides | 3.09 mmol/L | 270.42 mg/dL | | Total Bilirubin | 504 µmol/l | 29.5 mg/dL | | Direct Bilirubin | 442 µmol/l | 25.87 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 | | 500 IU/mL | | Deferoxamine | 400 µmol/L | 22.43 mg/dL | | Prednisone | 500 µmol/L | 17.92 mg/dL | | Methotrexate | 3000 µmol/L | 136 mg/dL | | Ferrous Sulfate | 1 mmol/L | 15.19 mg/dL | | Ampicillin | 250 µmol/L | 8.7 mg/dL | | Azithromycin | 20 µmol/L | 1.49 mg/dL | | Rifampicin | 100 µmol/L | 8.20 mg/dL | | Diltiazem | 10 µmol/L | 0.41 mg/dL | | Simvastatin | 10 µmol/L | 0.42 mg/dL | {22}------------------------------------------------ Image /page/22/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 written in a simple, sans-serif font and is left-aligned. ### Yumizen C1200 Transferrin ● | Serum/Plasma | | | |-------------------------|-------------|--------------| | Hemoglobin | 290 µmol/L | 500 mg/dL | | Triglycerides | 4.04 mmol/L | 353.28 mg/dL | | Total Bilirubin | 749 µmol/l | 43.84 mg/dL | | Direct Bilirubin | 408 µmol/l | 23.86 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 | 400 IU/mL | | ### • Yumizen C1200 Rheumatoid Factor | Serum | | | |-------------------------|-------------|--------------| | Hemoglobin | 290 µmol/l | 500 mg/dL | | Triglycerides | 6.02 mmol/l | 526.75 mg/dL | | Total Bilirubin | 535 µmol/l | 31.32 mg/dL | | Direct Bilirubin | 433 µmol/l | 25.34 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 | {23}------------------------------------------------ Image /page/23/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 light gray color and appears to be part of a document or report. ### 8.4 Yumizen C1200 Transferrin : Anticoagulant study ### Study materials : Anticoagulant : heparin-lithium Samples: single donors 59 paired serum/ plasma samples were evaluated on Yumizen C1200 analyser using Yumizen C1200 Transferrin reagent. For this study, each paired samples (sera and heparinized plasma) has been obtained from single donor. | Passing Bablok | N | Min | Max | Intercept | Slope | Correlation | |--------------------------------------------|----|-------|-------|-----------|--------|-------------| | Transferrin:
serum sample
(g/L) | 59 | 1.933 | 3.786 | | | | | Transferrin:
Heparin
sample
(g/L) | 59 | 1.901 | 3.724 | 0.04833 | 0.9691 | 0.995 | Conclusion : The results show there is not significative difference between serum and plasma with heparin specimens -> coagulation does not have an impact on Transferrin determination. {24}------------------------------------------------ Image /page/24/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 smaller, gray font. The text appears to be a section heading or title, possibly from a document or report. ### 8.5 Prozone / Antigen excess effect For each analyte, a range of high concentration samples is prepared in order to identify a high dose hook effect. #### Yumizen C1200 Ferritin ● An antigen excess effect is observed for samples with a concentration higher than 5043 ng/mL, as they have a rate which could be inside the calibration range and the assay could give underestimated results, but remaining inside the pathological range. For such samples, a prozone alarm will flag the samples having concentration higher than 5043 ng/mL. The flagged sample will be automatically rerun by the analyzer. #### ● Yumizen C1200 Transferrin No antigen excess has been detected up to a concentration of 40 g/L. #### ● Yumizen C1200 Rheumatoid Factor An antigen excess effect is observed for samples with a concentration higher than 229 IU/mL, as they have a rate which could be inside the calibration range and the assay could give underestimated results, but remaining inside the pathological range. For such samples, a prozone alarm will flag the samples having concentration higher than 229 IU/mL. The flagged sample will be automatically rerun by the analyzer. {25}------------------------------------------------ Image /page/25/Picture/0 description: The image shows the logo for HORIBA Medical at the top. The text "Medical" is written in a smaller font size below the word HORIBA. Below the logo, the text "Section 007. 510(k) summary" is written in a gray font. The text appears to be part of a document or report. ### 8.6 Method comparison with a predicate device #### Yumizen C1200 Ferritin ● This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Samples: Anonymous remnants of human serum specimens collected from blood bank. These samples are in the candidate measuring range and predicate measuring range. 103 native sera 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. | Passing Bablok | N | Min | Max | Intercept | Slope | Correlation – r2 | |----------------|-----|-------|--------|-----------|--------|------------------| | (ng/mL) | 103 | 16.74 | 413.00 | 2.105 | 0.9142 | 0.999 | #### ● Yumizen C1200 Transferrin This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Samples: Anonymous remnants of human serum specimens collected from CHU Nîmes (University Hospital Center). 115 native samples have been assayed in duplicate, in ascendant order and descendant order on 5 working days. Only the first replicate of each method will be used for the data analysis reported below. | Passing Bablok | N | Min | Max | Intercept | Slope | Correlation - r² | |----------------|-----|------|------|-----------|--------|------------------| | (g/L) | 115 | 0.37 | 4.81 | 0.006364 | 0.9455 | 0.993 | #### Yumizen C1200 Rheumatoid Factor ● This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Samples: Anonymous remnants of human serum specimens collected from blood bank. These samples are in the candidate measuring range and predicate measuring range. 113 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. | Passing Bablok | N | Min | Max | Intercept | Slope | Correlation – r² | |----------------|-----|---------|----------|-----------|-------|------------------| | (IU/mL) | 113 | 16.7900 | 118.8100 | -1.11 | 1.014 | 0.992 | {26}------------------------------------------------ Image /page/26/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 the title or heading of a document or section within a document. The image is simple and focuses on the company name and the section title. ## 8.7 Reagent Stability #### 8.7.1 Closed stability The closed stability was determined according to the CLSI guideline EP25-A. #### Yumizen C1200 Ferritin ● Stability before opening: Stable up to the expiry date on the label if stored at 2-10°C. Store protected from light. The shelf life claim for HORIBA Medical reagent is 18 months. #### . Yumizen C1200 Transferrin ### Stability before opening: Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light. The shelf life claim for HORIBA Medical reagent is 24 months. #### ● Yumizen C1200 Rheumatoid Factor ## Stability before opening: Stable up to the expiry date on the label if stored at 2-10°C. The shelf life claim for HORIBA Medical reagent is 18 months. ## 8.7.2 Open stability The open stability was determined according to the CLSI guideline EP25-A. ### On board reagent Stability: - The reagent stability claim for the Yumizen C1200 Ferritin is 2 months. - The reagent stability claim for the Yumizen C1200 Transferrin is 6 weeks. - The reagent stability claim for the Yumizen C1200 Rheumatoid Factor is 1 month. {27}------------------------------------------------ Image /page/27/Picture/0 description: The image shows the logo for HORIBA Medical, followed by the text "Section 007. 510(k) summary". The logo is in blue, and the text is in gray. The text is likely a section heading or title within a larger document. ### 8.8 Reference range The Reference Range was determined according to the CLSI guideline EP28-A3. #### ● Yumizen C1200 Ferritin - A Adults data (bibliographic reference and study- see below) - . Women : 50 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assaved in duplicates. Only the first replicate of each method will be used for the data analysis reported below. Only the first replicate result 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. Women : 10 - 120 ng/ml (µg/l) Reference: Roberts W.L., McMillin G.A., Burtis C.A., Bruns D.E., Reference Information for the Clinical Laboratory, TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics. 4ème Ed; Burtis C.A., Ashwood E.R., Bruns D.E., (Elsevier Saunders eds. St Louis, USA); 2006, 2269. - . Men : 95 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates. Only the first replicate of each method will be used for the data analysis reported below. Only the first replicate result 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. Men: 20 - 250 ng/ml (µg/1) Reference: Roberts W.L., McMillin G.A., Burtis C.A., Bruns D.E., Reference Information for the Clinical Laboratory, TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics. 4ème Ed; Burtis C.A., Ashwood E.R., Bruns D.E., (Elsevier Saunders eds. St Louis, USA); 2006, 2269. {28}------------------------------------------------ k191562 Yumizen C1200 Reagents #### ● Yumizen C1200 Transferrin 85 "normal samples" (28 women + 57 men) from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates. Only the first replicate of each method will be used for the data analysis reported below. Only the first replicate result 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. Normal range Transferrin - Serum 2 - 3.6 g/l (200 - 360 mg/dl) based on CRM 470. ### Reference: Dati F., Schumann G, Thomas L, Aguzzi F, Baudner S. Bienvenu J. et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against IFCC/BCR/CAP Reference Material (CRM 470). Eur. J Clin Chem. Cli Biochem. 1996; 34: 517-20. #### . Yumizen C1200 Rheumatoid Factor 60 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates. Only the first replicate of each method will be used for the data analysis reported below. Only the first replicate result 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. Normal range Rhumatoid Factor Adult < 14 IU/ml Reference: Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia: WB Saunders Company, 1990. {29}------------------------------------------------ Image /page/29/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 image appears to be a snippet from a document or presentation. ### 8.9 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. #### Conclusions for Performance Testing 8.10 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. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K191562](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBF/K191562) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com