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.

Device Description

Not Found

AI/ML Overview

The document describes the analytical performance characteristics of three devices: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, and Yumizen C1200 Rheumatoid Factor. Each device is intended for the quantitative in vitro diagnostic determination of specific substances in human serum, and sometimes plasma, using immunoturbidimetric or turbidimetric assays.

Here's an analysis of the acceptance criteria and study details for each device:

Yumizen C1200 Ferritin

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Measuring Range (Serum)	N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies)	10 to 450 ng/mL
Limit of Detection (Serum)	N/A (determined according to CLSI EP17-A2)	6.30 ng/mL
Limit of Quantitation (Serum)	N/A (determined according to CLSI EP17-A2)	9.39 ng/mL
Linearity (Serum)	N/A (determined according to CLSI EP06-A)	Evaluated from 13.3 to 426.6 ng/mL (appropriate)
Total Precision (Analyzer Variability) - Within Run CV	Low level: ≤ 8.0%Middle level: ≤ 6.0%High level: ≤ 6.0%	Level 1 Control (47.58 ng/mL): 3.6%Level 2 Control (279.31 ng/mL): 1.1%Sample 1 (29.56 ng/mL): 5.5%Sample 2 (50.87 ng/mL): 4.1%Sample 3 (172.63 ng/mL): 1.4%Sample 4 (328.60 ng/mL): 1.3%Sample 5 (403.21 ng/mL): 1.0%
Total Precision (Analyzer Variability) - Total CV	Low level: ≤ 10.0%Middle & High level: ≤ 8.0%	Level 1 Control: 4.9%Level 2 Control: 2.1%Sample 1: 7.9%Sample 2: 5.1%Sample 3: 1.9%Sample 4: 4.3%Sample 5: 1.4%
Total Precision (Lot to Lot Variability) - Within Run CV	Low level: ≤ 8.0%Middle level: ≤ 6.0%High level: ≤ 6.0%	Level 1 Control (52.84 ng/mL): 4.6%Level 2 Control (281.87 ng/mL): 0.9%Sample 1 (19.09 ng/mL): 8.8%Sample 2 (34.05 ng/mL): 6.5%Sample 3 (51.53 ng/mL): 3.6%Sample 4 (192.31 ng/mL): 1.4%Sample 5 (407.38 ng/mL): 0.9%
Total Precision (Lot to Lot Variability) - Total CV	Low level: ≤ 10.0%Middle & High level: ≤ 8.0%	Level 1 Control: 6.4%Level 2 Control: 1.6%Sample 1: 11.8% (above criterion, but "pvalue with 5% acceptable remains acceptable")Sample 2: 6.5%Sample 3: 3.8%Sample 4: 2.8%Sample 5: 1.4%
Interferences (Bias)	+/- 10% of value without interfering substances	Hemoglobin: up to 500 mg/dLTriglycerides: up to 270.42 mg/dLTotal Bilirubin: up to 29.5 mg/dLDirect Bilirubin: up to 25.87 mg/dLAscorbic Acid: up to 5.98 mg/dLOthers specified in document
Prozone / Antigen Excess Effect	Detect and flag samples with underestimated results due to high concentration	Antigen excess observed > 5043 ng/mL; an alarm will flag and re-run these samples.
Method Comparison (Correlation with Predicate)	N/A (determined acceptable by high correlation)	Correlation (r²) = 0.999 (for 103 samples, 16.74 - 413.00 ng/mL range)
Closed Stability	N/A (defined by statement)	18 months, stored at 2-10°C, protected from light.
Open Stability (On-board)	N/A (defined by statement)	2 months
Reference Range Verification	Support establishing ranges vs. literature	Women: 10 - 120 ng/ml (µg/l)Men: 20 - 250 ng/ml (µg/l)

2. Sample Size and Data Provenance (for test set)

Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum specimens".
Method Comparison: 103 native sera samples. Origin: "Anonymous remnants of human serum specimens collected from blood bank." Retrospective.
Reference Range: Women: 50 "normal samples". Men: 95 "normal samples". Origin: "blood bank." Retrospective.

3. Number of experts and qualifications (for ground truth)

Not applicable as this is an in vitro diagnostic device for quantitative measurement, not an AI evaluation requiring expert adjudication. Ground truth is instrument-derived or defined by reference methods/literature.

4. Adjudication method (for test set)

Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study

No, not applicable for this type of IVD device.

6. Standalone performance (algorithm only)

Yes, the performance data presented is for the device operating in standalone mode (algorithm only) as a quantitative measurement system.

7. Type of ground truth used

Analytical Performance (LOD, LOQ, Linearity, Precision, Interferences, Prozone/Antigen Excess): The "ground truth" is established through well-defined laboratory analytical methods and standards (CLSI guidelines EP17-A2, EP06-A, EP05-A3, EP07-A2). It relies on the accuracy of the reference materials and methods used in these studies.
Method Comparison: Comparison against a legally marketed predicate device (Beckman Coulter Ferritin (OSR61203) [K092505]) is used as the reference, with correlation analysis.
Reference Range: Verification against established literature references (e.g., TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics).

8. Sample size for the training set

Not applicable. This is not a machine learning model that requires a "training set" in that sense. The device's calibration curve establishment and internal parameters would be set by the manufacturer using validated reference materials and methodologies.

9. How the ground truth for the training set was established

Not applicable.

Yumizen C1200 Transferrin

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Measuring Range (Serum/Plasma)	N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies)	0.10 to 5.20 g/L
Limit of Detection (Serum/Plasma)	N/A (determined according to CLSI EP17-A2)	0.002 g/L
Limit of Quantitation (Serum/Plasma)	N/A (determined according to CLSI EP17-A2)	0.07 g/L
Linearity (Serum/Plasma)	N/A (determined according to CLSI EP06-A)	Evaluated from 0.15 to 4.61 g/L (appropriate)
Total Precision (Analyzer Variability) - Within Run CV	Low level: ≤ 6.0%Middle level: ≤ 4.5%High level: ≤ 3.8%	Level 1 Control (1.24 g/L): 1.2%Level 2 Control (3.35 g/L): 1.5%Sample 1 (0.78 g/L): 1.0%Sample 2 (1.02 g/L): 1.2%Sample 3 (1.83 g/L): 1.3%Sample 4 (3.78 g/L): 1.5%
Total Precision (Analyzer Variability) - Total CV	Low level: ≤ 8.0%Middle & High level: ≤ 6.0%	Level 1 Control: 3.6%Level 2 Control: 3.6%Sample 1: 4.5%Sample 2: 3.2%Sample 3: 2.3%Sample 4: 2.7%
Total Precision (Lot to Lot Variability) - Within Run CV	Low level: ≤ 6.0%Middle level: ≤ 4.5%High level: ≤ 3.8%	Level 1 Control (1.29 g/L): 3.5%Level 2 Control (3.41 g/L): 1.7%Sample 1 (0.77 g/L): 4.2%Sample 2 (1.08 g/L): 1.5%Sample 3 (1.96 g/L): 1.3%Sample 4 (3.54 g/L): 2.6%
Total Precision (Lot to Lot Variability) - Total CV	Low level: ≤ 8.0%Middle & High level: ≤ 6.0%	Level 1 Control: 6.6%Level 2 Control: 3.0%Sample 1: 5.4%Sample 2: 3.3%Sample 3: 3.4%Sample 4: 3.4%
Interferences (Bias)	+/- 10% of value without interfering substances	Hemoglobin: up to 500 mg/dLTriglycerides: up to 353.28 mg/dLTotal Bilirubin: up to 43.84 mg/dLDirect Bilirubin: up to 23.86 mg/dLAscorbic Acid: up to 5.98 mg/dLOthers specified in document
Anticoagulant Study (Serum vs. Heparin Plasma)	No significant difference between serum and plasma	Correlation (r) = 0.995, Intercept = 0.04833, Slope = 0.9691 (59 paired samples)
Prozone / Antigen Excess Effect	No antigen excess detected within claimed range	No antigen excess detected up to 40 g/L.
Method Comparison (Correlation with Predicate)	N/A (determined acceptable by high correlation)	Correlation (r²) = 0.993 (for 115 samples, 0.37 - 4.81 g/L range)
Closed Stability	N/A (defined by statement)	24 months, stored at 2-8°C, protected from light.
Open Stability (On-board)	N/A (defined by statement)	6 weeks
Reference Range Verification	Support establishing ranges vs. literature	Normal range Transferrin - Serum: 2 - 3.6 g/l (200 - 360 mg/dl)

2. Sample Size and Data Provenance (for test set)

Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum/plasma".
Method Comparison: 115 native samples. Origin: "Anonymous remnants of human serum specimens collected from CHU Nîmes (University Hospital Center)." Retrospective.
Anticoagulant Study: 59 paired serum/plasma samples. Origin: "single donors." Not specified if retrospective or prospective.
Reference Range: 85 "normal samples" (28 women + 57 men). Origin: "blood bank." Retrospective.

3. Number of experts and qualifications (for ground truth)

Not applicable.

4. Adjudication method (for test set)

Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study

No, not applicable.

6. Standalone performance (algorithm only)

Yes, the performance data presented is for the device operating in standalone mode (algorithm only).

7. Type of ground truth used

Analytical Performance: Established through CLSI guidelines (EP17-A2, EP06-A, EP05-A3, EP07-A2).
Method Comparison: Comparison against a legally marketed predicate device (Roche Diagnostics Transferrin Model :TRSF2 [K012393]).
Reference Range: Verification against established literature references (e.g., Dati et al., Eur. J Clin Chem. Cli Biochem. 1996).

8. Sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Yumizen C1200 Rheumatoid Factor

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Measuring Range (Serum)	N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies)	10 to 120 IU/mL
Limit of Detection (Serum)	N/A (determined according to CLSI EP17-A2)	4.07 IU/mL
Limit of Quantitation (Serum)	N/A (determined according to CLSI EP17-A2)	7.41 IU/mL
Linearity (Serum)	N/A (determined according to CLSI EP06-A)	Evaluated from 13.2 to 118.8 IU/mL (appropriate)
Total Precision (Analyzer Variability) - Within Run CV	Low level: ≤ 6.0%Middle level: ≤ 4.5%High level: ≤ 3.8%	Level 1 Control (40.99 IU/mL): 0.5%Level 2 Control (63.93 IU/mL): 0.4%Sample 1 (22.24 IU/mL): 1.2%Sample 2 (34.28 IU/mL): 0.8%Sample 3 (49.41 IU/mL): 0.5%Sample 4 (70.16 IU/mL): 0.5%Sample 5 (103.42 IU/mL): 0.8%
Total Precision (Analyzer Variability) - Total CV	Low level: ≤ 8.0%Middle & High level: ≤ 6.0%	Level 1 Control: 2.2%Level 2 Control: 2.5%Sample 1: 2.0%Sample 2: 2.2%Sample 3: 1.8%Sample 4: 1.6%Sample 5: 1.4%
Total Precision (Lot to Lot Variability) - Within Run CV	Low level: ≤ 6.0%Middle level: ≤ 4.5%High level: ≤ 3.8%	Level 1 Control (41.70 IU/mL): 1.8%Level 2 Control (67.05 IU/mL): 1.4%Sample 1 (17.30 IU/mL): 2.9%Sample 2 (30.88 IU/mL): 1.4%Sample 3 (53.08 IU/mL): 1.4%Sample 4 (70.24 IU/mL): 1.1%Sample 5 (102.14 IU/mL): 1.0%
Total Precision (Lot to Lot Variability) - Total CV	Low level: ≤ 8.0%Middle & High level: ≤ 6.0%	Level 1 Control: 1.9%Level 2 Control: 2.2%Sample 1: 3.1%Sample 2: 1.8%Sample 3: 3.2%Sample 4: 1.3%Sample 5: 1.8%
Interferences (Bias)	+/- 10% of value without interfering substances	Hemoglobin: up to 500 mg/dLTriglycerides: up to 526.75 mg/dLTotal Bilirubin: up to 31.32 mg/dLDirect Bilirubin: up to 25.34 mg/dLAscorbic Acid: up to 5.98 mg/dLOthers specified in document
Prozone / Antigen Excess Effect	Detect and flag samples with underestimated results due to high concentration	Antigen excess observed > 229 IU/mL; an alarm will flag and re-run these samples.
Method Comparison (Correlation with Predicate)	N/A (determined acceptable by high correlation)	Correlation (r²) = 0.992 (for 113 samples, 16.79 - 118.81 IU/mL range)
Closed Stability	N/A (defined by statement)	18 months, stored at 2-10°C.
Open Stability (On-board)	N/A (defined by statement)	1 month
Reference Range Verification	Support establishing ranges vs. literature	Normal range Rheumatoid Factor: Adult < 14 IU/ml

2. Sample Size and Data Provenance (for test set)

Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum".
Method Comparison: 113 native samples. Origin: "Anonymous remnants of human serum specimens collected from blood bank." Retrospective.
Reference Range: 60 "normal samples". Origin: "blood bank." Retrospective.

3. Number of experts and qualifications (for ground truth)

Not applicable.

4. Adjudication method (for test set)

Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study

No, not applicable.

6. Standalone performance (algorithm only)

Yes, the performance data presented is for the device operating in standalone mode (algorithm only).

7. Type of ground truth used

Analytical Performance: Established through CLSI guidelines (EP17-A2, EP06-A, EP05-A3, EP07-A2).
Method Comparison: Comparison against a legally marketed predicate device (Olympus RF Latex reagent (OSR61105) [K060201]).
Reference Range: Verification against established literature references (e.g., Tietz NW, Clinical Guide to Laboratory Tests, 3rd ed. 1990).

8. Sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

General Notes on the Studies:

The studies were designed to evaluate the analytical performance of the IVD reagents and the Yumizen C1200 analyzer according to recognized CLSI (Clinical and Laboratory Standards Institute) guidelines, which are standard for in vitro diagnostic device validation.
The term "acceptance criteria" is often implied by the CLSI guidelines themselves and the high correlation/precision values that are typical for these types of assays to demonstrate substantial equivalence to predicate devices. Explicit numerical acceptance criteria are sometimes only stated for the precision studies (e.g., %CV limits).
For the method comparison studies, the high correlation coefficients (r²) indicate good agreement with the predicate devices, supporting the claim of substantial equivalence.
The "test set" concept from AI/ML is not directly applicable here. The samples used for performance evaluation are analytical samples, control materials, and patient samples that cover the measuring range and demonstrate various performance characteristics of the assay.

Summary

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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

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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

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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 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.

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)

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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.

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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 C1200Ferritin	Yumizen C1200 Ferritin reagent is intended for the quantitative in vitrodiagnostic determination of Ferritin in human serum by latex-enhancedimmunoturbidimetric assay. Measurements of ferritin aid in the diagnosisof diseases affecting iron metabolism, hemochromatosis (iron overload)and iron deficiency anemia.
Yumizen C1200Transferrin	Yumizen C1200 Transferrin reagent is intended for the quantitative in vitrodiagnostic determination of Transferrin in human serum and lithiumheparin plasma by turbidimetry.Measurement of transferrin levels aids in the diagnosis of malnutrition,acute inflammation, infection, and iron deficiency anemia.
Yumizen C1200Rheumatoid Factor	Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitativein vitro diagnostic determination of rheumatoid factor in human serum bylatex-enhanced immunoturbidimetric assay.Measurement of rheumatoid factor may aid in the diagnosis of rheumatoidarthritis.

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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	Predicate510(k)number
Yumizen C1200Ferritin	Ferritin ( OSR61203)	BECKMAN COULTER	K092505
Yumizen C1200Transferrin	Transferrin Model :TRSF2	Roche Diagnostics	K012393
Yumizen C1200Rheumatoid Factor	Olympus RF Latex reagent(OSR61105)	Olympus America, Inc.	K060201

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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 thedetermination of ferritin concentrations inhuman serum and plasma on the BeckmanCoulter AU clinical chemistry analyzers.Serum ferritin is an indicator of body ironstores: it has been shown to correlate withstainable bone marrow iron. Measurementsof ferritin aid in the diagnosis of diseasesaffecting iron metabolism, such ashemochromatosis (iron overload) and irondeficiency anemia.	Yumizen C1200 Ferritin reagent isintended for the quantitative in vitrodiagnostic determination of Ferritin inhuman serum by latex-enhancedimmunoturbidimetric assay.Measurements of ferritin aid in thediagnosis of diseases affecting ironmetabolism, hemochromatosis (ironoverload) and iron deficiency anemia.
Reagent format	Liquid	Same
Measurement	Quantitative	Same
Method	Latex-enhanced immuno-turbidimetricmethod	Same
Product code	DBF	Same
On board Stability	Once opened, the reagent cassette placedin the refrigerator compartment is stablefor 60 days	Once opened, the reagent cassette placedin the refrigerator compartment is stablefor 2 months (or 60 days).
CalibrationStability	The frequency of calibration for theFerritin procedure is every30 days	The reagent is calibrated on Day 0. Thecalibration stability is checked by testing2 control specimens.The calibration stability is1 month(or 30 days)

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Item	Predicate K092505	Candidate
Device Name	Ferritin (OSR61203)	Yumizen C1200 Ferritin (1300023880)
Instrument	Beckman Coulter AU400 ClinicalChemistry Analyzer	Yumizen C1200 Clinical chemistryanalyzer
Manufactured by	BECKMAN COULTER	HORIBA ABX SAS
Sample type	Serum,Li-heparin plasmaand EDTA plasma samples	Serum
Packaging	Cassette of :R1= 4 x 24 mLR2= 4 x 12 mL	Cassette of :R1: 6 x 11 mLR2: 6 x 7 mL
Shelf-life	Unopened, up to the stated expiry datewhen stored at 2-8°C.	Stable up to the expiration date if storedat 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/mLMen: $16 - 243$ 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
1. Packaging: Packaging is different; depends on cassette capacity.
1. Reagent stability/ Shelf-life:storage temperature is different.
1. Analytical range: the measuring range for Yumizen C1200 Ferritin is slightly higher on the lower end
1. 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.

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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 quantitativedetermination of transferrin in humanserum and plasma in Roche/Hitachi cobasc systems.	Yumizen C1200 Transferrin reagent isintended for the quantitative in vitrodiagnostic determination of Transferrinin human and lithium heparin plasma byturbidimetry.Measurement of transferrin levels aids inthe diagnosis of malnutrition, acuteinflammation, infection, and irondeficiency anemia.
Sample type	Serumplasma	Serumplasma
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 labelif stored at 2-8°C.
Analytical Range	Measuring Range0.1-5.2 g/L	Measuring Range0.10-5.20 g/L
Reference range	200-360 mg/dL	200-360 mg/dL

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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 chemistryanalyzer
Manufactured by	ROCHE	HORIBA ABX SAS
On board Stability	4 weeks	Once opened, the reagent cassette placedin the refrigerated compartment is stablefor 6 weeks.

Discussion on the analysis differences :

Instrument & Manufacturer: Yumizen C1200 Transferrin is used on Yumizen C1200.

Yumizen C1200 Transferrin is manufactured by HORIBA ABX SAS.

Reagent stability: the on board stability of Yumizen C1200 Transferrin is longer.

Stability depends on the reagent composition and cassette capacity.

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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 thequantitative determination of RheumatoidFactor (RF) in human serum and plasmaon Olympus AU analyzers.Measurement of rheumatoid factor mayaid in the diagnosis of rheumatoid arthritis	Yumizen C1200 Rheumatoid Factorreagent is intended for the quantitative invitro diagnostic determination ofrheumatoid factor in human serum bylatex-enhanced immunoturbidimetricassay.Measurement of rheumatoid factor mayaid in the diagnosis of rheumatoidarthritis.
Manufactured by	OLYMPUS AMERICA, INC	HORIBA ABX SAS
Measurement	Quantitative	Quantitative
Method	Latex-enhanced Immunoturbidimetry	Same
Product code	DHR	Same
CalibrationStability	The frequency of calibration for the RFLatex 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

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Item	Predicate K060201	Candidate
Device Name	Rheumatoid Factor reagent model :OSR61105	Yumizen C1200 Rheumatoid Factor(1300023888)
Instrument	Olympus AU400 Clinical ChemistryAnalyzer	Yumizen C1200 Clinical chemistryanalyzer
Sample type	Serum, plasma	Serum
Reagent format	Liquid	Same
Packaging	Cassette of :R1= 4 x 24 mLR2= 4 x 8mL	Cassette of :R1: 6 x 13 mLR2: 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 dateif stored at 2-10°C
On board Stability	Once opened, the reagent is stablefor 60 days in refrigerated compartment ofanalyzer.	Once opened, the reagent cassette placedin the refrigerator compartment is stablefor 1 month (or 30 days)
Discussion on the analysis differences :

ii. Comparison with predicate Device: Differences

Instrument: Yumizen C1200 Rheumatoid Factor is used on Yumizen C1200
Packaging: Packaging is different; depends on cassette capacity.
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

Sample type: Yumizen C1200 RF uses serum only.

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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

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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 ofdetection	Limit ofquantitation	Linearity evaluated	Measuring range
Serum	6.30 ng/mL	9.39 ng/mL	13.3 - 426.6 ng/mL	10 to 450 ng/mL
SerumPost-dilution	NA	NA	NA	until 2250 ng/mL

● Yumizen C1200 Transferrin

> Results :

	Limit ofdetection	Limit ofquantitation	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/PlasmaPost-dilution	NA	NA	NA	15.60 until g/L

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Yumizen C1200 Rheumatoid Factor ●

》 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

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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 C1200Level 1 ProteinControl	240	47.58	3.6	0.0	1.5	3.1	4.9
Yumizen C1200Level 2 ProteinControl	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

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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 C1200Level 1 ProteinControl	90	52.84	4.6	4.5	6.4	0.0	6.4
Yumizen C1200Level 2 ProteinControl	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.

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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 C1200Level 1 ProteinControl	240	1.24	1.2	0.7	2.1	2.5	3.6
Yumizen C1200Level 2 ProteinControl	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

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► 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 C1200Level 1 ProteinControl	90	1.29	3.5	5.3	6.3	1.7	6.6
Yumizen C1200Level 2 ProteinControl	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

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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-Instrumentt (%CV)	Total(%CV)
Yumizen C1200Level 1 ProteinControl	240	40.99	0.5	0.4	1.2	1.7	2.2
Yumizen C1200Level 2 ProteinControl	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

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► 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 C1200Level 1 ProteinControl	90	41.70	1.8	0.3	1.8	0.6	1.9
Yumizen C1200Level 2 ProteinControl	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

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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
AcetylsalicylicAcid	3.62 mmol/L	65.16 mg/dL
Ibuprofen	2.43 mmol/L	50.10 mg/dL
Acetaminophen	1324 µmol/L	20 mg/dL
RheumatoidFactor		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

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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
AcetylsalicylicAcid	3.62 mmol/L	65.16 mg/dL
Ibuprofen	2.43 mmol/L	50.10 mg/dL
Acetaminophen	1324 µmol/L	20 mg/dL
RheumatoidFactor	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
AcetylsalicylicAcid	3.62 mmol/L	65.16 mg/dL
Ibuprofen	2.43 mmol/L	50.10 mg/dL
Acetaminophen	1324 µmol/L	20 mg/dL

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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:Heparinsample(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.

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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.

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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

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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.

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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.

Men: 20 - 250 ng/ml (µg/1)

Reference:

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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.

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.

Normal range Rhumatoid Factor Adult < 14 IU/ml

Reference:

Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia: WB Saunders Company, 1990.

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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.

Regulation Number and Section

§ 866.5340 Ferritin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).