(267 days)
Not Found
No
The summary describes standard in vitro diagnostic assays (immunoturbidimetric and turbidimetric) and their analytical performance characteristics. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical validation methods.
No
Explanation: This device is an in vitro diagnostic (IVD) reagent used for quantitative measurements of biomarkers (Ferritin, Transferrin, Rheumatoid Factor) to aid in the diagnosis of various conditions. It does not provide any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Yumizen C1200 reagents are intended for "quantitative in vitro diagnostic determination" of various substances, and that "Measurements… aid in the diagnosis of diseases." This clearly indicates its role in diagnosis.
No
The device is described as a reagent for in vitro diagnostic determination using a latex-enhanced immunoturbidimetric assay and turbidimetry, which are laboratory methods involving physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents are "intended for the quantitative in vitro diagnostic determination" of Ferritin, Transferrin, and Rheumatoid Factor in human serum and plasma. It also clearly states that these measurements "aid in the diagnosis of diseases." This language is a key indicator of an IVD.
- Nature of the Tests: The tests described (latex-enhanced immunoturbidimetric assay and turbidimetry) are laboratory tests performed on biological samples (serum and plasma) to provide information about a patient's health status. This is the core function of an IVD.
- Clinical Significance: The document links the measurement of these analytes to the diagnosis of specific medical conditions (iron metabolism disorders, hemochromatosis, iron deficiency anemia, malnutrition, acute inflammation, infection, rheumatoid arthritis). This demonstrates the clinical utility of the device in aiding medical diagnosis.
- Performance Studies: The detailed performance studies (measuring range, accuracy, precision, interferences, method comparison, reagent stability, reference range) are typical evaluations required for IVD devices to demonstrate their analytical performance and suitability for clinical use.
- Predicate Devices: The mention of predicate devices with K numbers (K092505, K012393, K060201) indicates that these reagents are being compared to previously cleared IVD devices, which is a common regulatory pathway for new IVDs.
- Intended User/Care Setting: The intended user is a "Clinical laboratory," which is where IVD tests are typically performed.
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DBF, DDG, DHR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Characteristics
Measuring Range
Yumizen C1200 Ferritin
- Study Type: Limit of detection and quantitation determined according to CLSI guideline EP17-A2. Linearity determined according to CLSI guideline EP06-A.
- Results:
- Serum:
- Limit of detection: 6.30 ng/mL
- Limit of quantitation: 9.39 ng/mL
- Linearity evaluated: 13.3 - 426.6 ng/mL
- Measuring range: 10 to 450 ng/mL
- Serum Post-dilution:
- Measuring range: until 2250 ng/mL
- Serum:
Yumizen C1200 Transferrin
- Study Type: Limit of detection and quantitation determined according to CLSI guideline EP17-A2. Linearity determined according to CLSI guideline EP06-A.
- Results:
- Serum/Plasma:
- Limit of detection: 0.002 g/L
- Limit of quantitation: 0.07 g/L
- Linearity evaluated: 0.15 - 4.61 g/L
- Measuring range: 0.10 to 5.20 g/L
- Serum/Plasma Post-dilution:
- Measuring range: 15.60 until g/L
- Serum/Plasma:
Yumizen C1200 Rheumatoid Factor
- Study Type: Limit of detection and quantitation determined according to CLSI guideline EP17-A2. Linearity determined according to CLSI guideline EP06-A.
- Results:
- Serum:
- Limit of detection: 4.07 IU/mL
- Limit of quantitation: 7.41 IU/mL
- Linearity evaluated: 13.2 - 118.8 IU/mL
- Measuring range: 10 to 120 IU/mL
- Serum Post-dilution:
- Measuring range: until 1200 IU/mL
- Serum:
Accuracy and Precision
Yumizen C1200 Ferritin
- Total Precision (analyzer variability - 20x2x2 study)
- Sample Size: 240 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 47.58 ng/mL, Total CV 4.9%
- Yumizen C1200 Level 2 Protein Control: Mean 279.31 ng/mL, Total CV 2.1%
- Sample 1: Mean 29.56 ng/mL, Total CV 7.9%
- Sample 2: Mean 50.87 ng/mL, Total CV 5.1%
- Sample 3: Mean 172.63 ng/mL, Total CV 1.9%
- Sample 4: Mean 328.60 ng/mL, Total CV 4.3%
- Sample 5: Mean 403.21 ng/mL, Total CV 1.4%
- Lot to Lot variability (3x5x2x3)
- Sample Size: 90 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 52.84 ng/mL, Total CV 6.4%
- Yumizen C1200 Level 2 Protein Control: Mean 281.87 ng/mL, Total CV 1.6%
- Sample 1: Mean 19.09 ng/mL, Total CV 11.8%
- Sample 2: Mean 34.05 ng/mL, Total CV 6.5%
- Sample 3: Mean 51.53 ng/mL, Total CV 3.8%
- Sample 4: Mean 192.31 ng/mL, Total CV 2.8%
- Sample 5: Mean 407.38 ng/mL, Total CV 1.4%
Yumizen C1200 Transferrin
- Total Precision (analyzer variability - 20x2x2 study)
- Sample Size: 240 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 1.24 g/L, Total CV 3.6%
- Yumizen C1200 Level 2 Protein Control: Mean 3.35 g/L, Total CV 3.6%
- Sample 1: Mean 0.78 g/L, Total CV 4.5%
- Sample 2: Mean 1.02 g/L, Total CV 3.2%
- Sample 3: Mean 1.83 g/L, Total CV 2.3%
- Sample 4: Mean 3.78 g/L, Total CV 2.7%
- Lot to Lot variability (3x5x2x3)
- Sample Size: 90 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 1.29 g/L, Total CV 6.6%
- Yumizen C1200 Level 2 Protein Control: Mean 3.41 g/L, Total CV 3.0%
- Sample 1: Mean 0.77 g/L, Total CV 5.4%
- Sample 2: Mean 1.08 g/L, Total CV 3.3%
- Sample 3: Mean 1.96 g/L, Total CV 3.4%
- Sample 4: Mean 3.54 g/L, Total CV 3.4%
Yumizen C1200 Rheumatoid Factor
- Total Precision (analyzer variability - 20x2x2 study)
- Sample Size: 240 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 40.99 IU/mL, Total CV 2.2%
- Yumizen C1200 Level 2 Protein Control: Mean 63.93 IU/mL, Total CV 2.5%
- Sample 1: Mean 22.24 IU/mL, Total CV 2.0%
- Sample 2: Mean 34.28 IU/mL, Total CV 2.2%
- Sample 3: Mean 49.41 IU/mL, Total CV 1.8%
- Sample 4: Mean 70.16 IU/mL, Total CV 1.6%
- Sample 5: Mean 103.42 IU/mL, Total CV 1.4%
- Lot to Lot variability (3x5x2x3)
- Sample Size: 90 for each sample type
- Key Results:
- Yumizen C1200 Level 1 Protein Control: Mean 41.70 IU/mL, Total CV 1.9%
- Yumizen C1200 Level 2 Protein Control: Mean 67.05 IU/mL, Total CV 2.2%
- Sample 1: Mean 17.30 IU/mL, Total CV 3.1%
- Sample 2: Mean 30.88 IU/mL, Total CV 1.8%
- Sample 3: Mean 53.08 IU/mL, Total CV 3.2%
- Sample 4: Mean 70.24 IU/mL, Total CV 1.3%
- Sample 5: Mean 102.14 IU/mL, Total CV 1.8%
Interferences
- Study Type: Determined according to CLSI guideline EP07-A2. Acceptable bias is +/-10% of the value without interfering substances.
- Key Results: Highest values for which no interferences higher than 10% have been observed are listed in the tables for each analyte.
Yumizen C1200 Transferrin : Anticoagulant study
- Study Materials: 59 paired serum/plasma samples (heparin-lithium) from single donors.
- Key Results: No significant difference between serum and plasma with heparin specimens. Coagulation does not have an impact on Transferrin determination.
- Correlation: 0.995 (Passing Bablok)
Prozone / Antigen excess effect
- Yumizen C1200 Ferritin: Antigen excess observed for samples > 5043 ng/mL. A prozone alarm flags samples > 5043 ng/mL, which are then automatically rerun.
- Yumizen C1200 Transferrin: No antigen excess detected up to 40 g/L.
- Yumizen C1200 Rheumatoid Factor: Antigen excess observed for samples > 229 IU/mL. A prozone alarm flags samples > 229 IU/mL, which are then automatically rerun.
Method comparison with a predicate device
- Study Type: Carried out using recommendations from CLSI EP-9A3 guidance.
- Yumizen C1200 Ferritin
- Samples: 103 native sera samples from blood bank, assayed in duplicate.
- Correlation (r²): 0.999 (Passing Bablok)
- Yumizen C1200 Transferrin
- Samples: 115 native samples from CHU Nîmes (University Hospital Center), assayed in duplicate.
- Correlation (r²): 0.993 (Passing Bablok)
- Yumizen C1200 Rheumatoid Factor
- Samples: 113 native samples from blood bank, assayed in duplicate.
- Correlation (r²): 0.992 (Passing Bablok)
Reagent Stability
- Study Type: Determined according to CLSI guideline EP25-A.
- Closed stability
- Yumizen C1200 Ferritin: Stable up to expiry date (18 months) if stored at 2-10°C, protected from light.
- Yumizen C1200 Transferrin: Stable up to expiry date (24 months) if stored at 2-8°C, protected from light.
- Yumizen C1200 Rheumatoid Factor: Stable up to expiry date (18 months) if stored at 2-10°C.
- Open stability (On board reagent Stability)
- Yumizen C1200 Ferritin: 2 months.
- Yumizen C1200 Transferrin: 6 weeks.
- Yumizen C1200 Rheumatoid Factor: 1 month.
Reference range
- Study Type: Determined according to CLSI guideline EP28-A3. Verification studies support reference ranges established through literature.
- Yumizen C1200 Ferritin
- Adults:
- Women: 10 - 120 ng/ml (µg/l) (50 normal samples assayed)
- Men: 20 - 250 ng/ml (µg/1) (95 normal samples assayed)
- Adults:
- Yumizen C1200 Transferrin
- Normal range Transferrin - Serum: 2 - 3.6 g/l (200 - 360 mg/dl) based on CRM 470. (85 normal samples (28 women + 57 men) assayed)
- Yumizen C1200 Rheumatoid Factor
- Normal range Rhumatoid Factor Adult:
§ 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).
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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
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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 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)
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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 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. |
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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 |
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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 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) |
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| 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 :
-
- Instrument: Yumizen C1200 Ferritin is used on Yumizen C1200
-
- Packaging: Packaging is different; depends on cassette capacity.
-
- Reagent stability/ Shelf-life:storage temperature is different.
-
- Analytical range: the measuring range for Yumizen C1200 Ferritin is slightly higher on the lower end
-
- 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 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 |
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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 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 :
- 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 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
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| 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
-
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 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 |
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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 |
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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 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 |
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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 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.
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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 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 |
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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 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 |
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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-
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 |
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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 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 |
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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 |
| 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 |
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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 |
| 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 |
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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: | ||||||
| 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.
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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.
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.
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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.
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