← Product Code [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP) · K193525 # Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525) _HORIBA ABX SAS · CZP · Jun 26, 2020 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K193525 ## Device Facts - **Applicant:** HORIBA ABX SAS - **Product Code:** [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP.md) - **Decision Date:** Jun 26, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use Yumizen C1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings. Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings. Yumizen C1200 Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings. ## Device Story Yumizen C1200 Immunoglobulin A, G, and M reagents are liquid, ready-to-use immunoturbidimetric assays for use on the Yumizen C1200 clinical chemistry analyzer. The device measures the concentration of specific immunoglobulins in human serum or lithium heparin plasma samples via an antigen-antibody reaction. The analyzer performs photometric measurements to determine the turbidity resulting from this reaction. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Results are provided to clinicians to assist in diagnosing abnormal protein metabolism and immune system deficiencies. The device provides quantitative results that are used in conjunction with other clinical and laboratory findings to support patient management. ## Clinical Evidence Bench testing only. Performance validated via precision (repeatability, between-run, between-day, between-instrument, lot-to-lot), linearity (R² ≥ 0.998), and interference studies. Method comparison against predicate devices using 129 (IgA), 214 (IgG), and 153 (IgM) remnant serum samples showed high correlation (r ≥ 0.996) and Passing-Bablok slopes near 1.0. Reference ranges verified using blood bank samples. ## Technological Characteristics Liquid immunoturbidimetric reagents; TRIS buffer with goat anti-human IgA, IgG, or IgM antibodies. Traceable to ERM-DA470k/IFCC. Designed for use on Yumizen C1200 analyzers. Measuring ranges: IgA (10–700 mg/dL), IgG (75–3000 mg/dL), IgM (20–500 mg/dL). ## Regulatory Identification An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. ## Predicate Devices - Olympus IgA reagent (OSR6X171) ([K073489](/device/K073489.md)) - Olympus IgG reagent (OSR6X172) ([K073490](/device/K073490.md)) - Olympus IgM reagent (OSR6X173) ([K073487](/device/K073487.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ June 26, 2020 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION". Horiba ABX SAS Caroline Ferrer Regulatory Affairs Manager Parc Euromedecine, Rue du Caducee BP7290 Montpellier Cedex 4, 341184 France Re: K193525 Trade/Device Name: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E immunological test system Regulatory Class: Class II Product Code: CZP, DEW, CFN Dated: December 17, 2019 Received: December 19, 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, Ying (Katelin) Mao, Ph.D Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K193525 Device Name Yumizen C1200 Immunoglobulin A Yumizen C1200 Immunoglobuline G Yumizen C1200 Immunoglobulin M #### Indications for Use (Describe) Yumizen C1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings, Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings. Yumizen C1200 Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| |
X Prescription Use (Part 21 CFR 801 Subpart D)
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the HORIBA Medical logo. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter letters, is the word "Medical". There is also a number string that reads "007-510(d)". Section 007. 510(k) summary # SECTION 007: 510(k) Summary of K193525 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo is the text "Section 007. 510(k) summary" in a gray font. The text appears to be a section heading or title, possibly from a document or report. - 1- Date of Summary Date submitted : 26th June, 2020 ### 2- Company HORIBA ABX SAS HORIBA MEDICAL Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 France ### 3- Contact person Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com) Telephone: + (33) 4 67 14 1843 Fax: + (33) 4 67 14 1517 ### 4- Product Name Yumizen C1200 Immunoglobulin A (1300023881) Yumizen C1200 Immunoglobulin G (1300023883) Yumizen C1200 Immunoglobulin M (1300023884) ### 5- Device Name and Classification #### ● Intended use The devices involved by the 510(k) submission file are the following: | Device's names | Intended Use | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Yumizen C1200
Immunoglobulin A | Yumizen C1200 Immunoglobulin A reagent is intended for the
quantitative in vitro diagnostic determination of Immunoglobulin A (IgA)
in serum and lithium heparin plasma by immunoturbidimetry on Yumizen
analyzers. Measurement of this immunoglobulin aids in the diagnosis of
abnormal protein metabolism and the body's lack of ability to resist
infectious agents. This test should be used in conjunction with other
laboratory and clinical findings. | | Yumizen C1200
Immunoglobulin G | Yumizen C1200 Immunoglobulin G reagent is intended for the
quantitative in vitro diagnostic determination of Immunoglobulin G (IgG)
in serum and lithium heparin plasma by immunoturbidimetry on Yumizen
analyzers. Measurement of this immunoglobulin aids in the diagnosis of
abnormal protein metabolism and the body's lack of ability to resist
infectious agents. This test should be used in conjunction with other
laboratory and clinical findings. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter blue letters, is the word "Medical." Section 007. 510(k) summary | Yumizen C1200
Immunoglobulin M | Yumizen C1200 Immunoglobulin M reagent is intended for the
quantitative in vitro diagnostic determination of Immunoglobulin M (IgM)
in serum and lithium heparin plasma by immunoturbidimetry on Yumizen
analyzers. Measurement of this immunoglobulin aids in the diagnosis of
abnormal protein metabolism and the body's lack of ability to resist
infectious agents. This test should be used in conjunction with other
laboratory and clinical findings. | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### Classification and Description ● | Trade/Proprietary Name: | Yumizen C1200 Immunoglobulin A | |-------------------------|-------------------------------------------------------------------------| | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5510: Immunoglobulins A, G, M, D, and E immunological test systems | | Product Code: | CZP | | Panel: | Immunology (82) | | Trade/Proprietary Name: | Yumizen C1200 Immunoglobulin G | | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5510: Immunoglobulins A, G, M, D, and E immunological test | | Product Code: | DEW | | Panel: | Immunology (82) | | Trade/Proprietary Name: | Yumizen C1200 Immunoglobulin M | | Device Class: | Class II / 510(k) required | | Classification Name: | §866.5510: Immunoglobulins A, G, M, D, and E immunological test system | | Product Code: | CFN | | Panel: | Immunology (82) | ### 6- Substantial Equivalence Information The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a smaller, gray font. The text appears to be a section heading or title, possibly from a document or report. ### Predicate Device Name and 510(k) number: | Candidate device | Predicate device | Predicate Manufacturer | Predicate
510(k)
number | |-----------------------------------|-----------------------------------|------------------------|-------------------------------| | Yumizen C1200
Immunoglobulin A | Olympus IgA reagent
(OSR6X171) | BECKMAN COULTER | K073489 | | Yumizen C1200
Immunoglobulin G | Olympus IgG reagent
(OSR6X172) | BECKMAN COULTER | K073490 | | Yumizen C1200
Immunoglobulin M | Olympus IgM reagent
(OSR6X173) | BECKMAN COULTER | K073487 | The following tables show the similarities and differences and demonstrates substantial equivalence between the candidate device and its predicate device identified below. ### a. Yumizen C1200 Immunoglobulin A ### i. Comparison with predicate Device : Similarities | Item | Predicate K073489 | Candidate | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | OSR6X171 | Yumizen C1200 Immunoglobulin A
(1300023881) | | Intended Use | System reagent for the quantitative
determination of IgA immunoglobulins in
human serum and plasma on Beckman
Coulter AU analyzers.
The spectrum of abnormalities in serum
immunoglobulin concentrations is broad.
Abnormal concentrations range from a
virtual absence of one or more of the three
major classes of immunoglobulin (IgG,
IgA, and IgM) to polyclonal increases in
one or more immunoglobulins.
Measurement of these immunoglobulins
aids in the diagnosis of abnormal protein
metabolism and the body's lack of ability
to resist infectious agents.
For in vitro diagnostic use. | Yumizen C1200 Immunoglobulin A
reagent is intended for the quantitative in
vitro diagnostic determination of
Immunoglobulin A (IgA) in serum and
lithium heparin plasma by
immunoturbidimetry on Yumizen
analyzers. Measurement of this
immunoglobulin aids in the diagnosis of
abnormal protein metabolism and the
body's lack of ability to resist infectious
agents. This test should be used in
conjunction with other laboratory and
clinical findings. | | Reagent format | Liquid | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below "HORIBA" is the word "Medical" in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name. Section 007. 510(k) summary | Item | Predicate K073489 | Candidate | |------------------|---------------------------------------------------|----------------------------------------------------| | Measurement | Quantitative | Same | | Analytical Range | Measuring Range
0.1 - 7.00 g/dL
10-700 mg/L | Measuring Range
0.10 - 7.00 g/dL
10-700 mg/L | # ii. Comparison with predicate Device: Differences | Item | Predicate K073489 | Candidate | | |-------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--| | Device Name | OSR6X171 | Yumizen C1200 Immunoglobulin A
(1300023881) | | | Instrument | Olympus AU400 Clinical Chemistry
Analyzer | Yumizen C1200 Clinical chemistry
Analyzer | | | Manufactured by | BECKMAN COULTER | HORIBA ABX SAS | | | Method | Turbidimetry | Immunoturbidimetry | | | Packaging | 4x14 mL (R1)
4x11 mL (R2) | 6x20 mL (R1)
6x20 mL (R2) | | | Product code | CFN | CZP | | | Reagent
On board Stability | 60 days | 6 weeks | | | Reference range | 66-433 mg/dL
0.66-4.33 g/L | 70-400 mg/dL
0.70-4.00 g/L | | | Sample Stability | Stable up to 3 days when stored 2-8°C
< -20°C stability claim was not defined
(specified) | 8 months at 20-25°C
8 months at 4-8°C
8 months at -20°C | | | Sample type | Serum,
Lithium-heparin plasma
EDTA plasma | Serum
Lithium-heparin plasma | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for HORIBA Medical in blue font. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be a heading or title for a document or section of a document. K193525 Yumizen C1200 Reagents ### b. Yumizen C1200 Immunoglobulin G #### Predicate K073490 Item Candidate Yumizen C1200 Immunoglobulin G Device Name OSR6X172 (1300023883) Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in System reagent for the quantitative vitro diagnostic determination of determination of IgG immunoglobulins in Immunoglobulin G (IgG) in serum and human serum and plasma on Beckman lithium heparin plasma by Coulter AU analyzers. immunoturbidimetry on Yumizen analyzers. Measurement of this Intended Use The measurement of IgG aids in the immunoglobulin aids in the diagnosis of diagnosis of abnormal protein metabolism abnormal protein metabolism and the and the body's lack of ability to resist body's lack of ability to resist infectious infectious agents. agents. This test should be used in For in vitro diagnostic use. conjunction with other laboratory and clinical findings. Reagent format Liquid Same Measurement Quantitative Same Stable up to expiry date on the label if Stable up to expiry date on the label if stored at 2-8°C.Store protected from Shelf-life stored at 2-8°C. light. Measuring Range Measuring Range Analytical Range 0.75 - 30.00 g/L 0.75 - 30.00 g/L 75-3000 mg/dL 75-3000 mg/dL ### i. Comparison with predicate Device : Similarities {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for HORIBA Medical in blue font. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be a section heading or title within a larger document. | Item | Predicate K073490 | Candidate | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | OSR6X172 | Yumizen C1200 Immunoglobulin G
(1300023883) | | Instrument | Olympus AU400 Clinical Chemistry
Analyzer | Yumizen C1200 Clinical chemistry
Analyzer | | Manufactured by | BECKMAN COULTER | HORIBA ABX SAS | | Packaging | 4x22mL (R1)
4x20 mL (R2) | 6x20 mL (R1)
6x20 mL (R2) | | Method | Turbidimetry | Immunoturbidimetry | | Product code | CFN | DEW | | Reagent
On board Stability | 90 days | 6 weeks | | Reference range | 635-1741 mg/dL
6.35-17.41 g/L | 700-1600 mg/dL
7-16 g/L | | Sample Stability | 2-8°C for up to 3 days | 1 week at 20-25°C
3 months at 4-8°C
>6 months at -20°C | | Sample type | Serum,
Lithium-heparin plasma
EDTA | Serum
Lithium-heparin plasma | | Item | Predicate K073487 | Candidate | | Device Name | OSR6X173 | Yumizen C1200 Immunoglobulin M
(1300023884) | | Intended Use | System reagent for the quantitative
determination of IgM immunoglobulins in
human serum and plasma on Beckman
Coulter AU analyzers.
System reagent for the quantitative
determination of IgM immunoglobulins in
human serum and plasma on Beckman
Coulter AU analyzers
The spectrum of abnormalities in serum
immunoglobulin concentrations is broad.
Abnormal concentrations range from a
virtual absence of one or more of the three
major classes of immunoglobulin (IgA,
IgG, and IgM) to polyclonal increases in
one or more immunoglobulins.
Measurement of these immunoglobulins
aids in the diagnosis of abnormal protein
metabolism and the body's lack of ability
to resist infectious agents.
For in vitro diagnostic use. | Yumizen C1200 Immunoglobulin M
reagent is intended for the quantitative in
vitro diagnostic determination of
Immunoglobulin M (IgM) in serum and
lithium heparin plasma by
immunoturbidimetry on Yumizen
analyzers. Measurement of this
immunoglobulin aids in the diagnosis of
abnormal protein metabolism and the
body's lack of ability to resist infectious
agents.
This test should be used in conjunction
with other laboratory and clinical
findings. | | Reagent format | Liquid | Same | | Measurement | Quantitative | Same | | Procode | CFN | Same | | Shelf-life | Stable up to expiry date on the label if
stored at 2-8°C. | Stable up to expiry date on the label if
stored at 2-8°C.Store protected from
light. | | Analytical Range | Measuring Range
0.20-5.00 g/L
20-500 mg/dL | Measuring Range
0.20-5.00 g/L
20-500 mg/dL | | Item | Predicate K073487 | Candidate | | Device Name | OSR6X173 | Yumizen C1200 Immunoglobulin M
(1300023884) | | Instrument | Olympus AU400 Clinical Chemistry
Analyzer | Yumizen C1200 Clinical chemistry
Analyzer | | Manufactured by | BECKMAN COULTER | HORIBA ABX SAS | | Packaging | 4x14mL (R1)
4x11 mL (R2) | 6x20 mL (R1)
6x20 mL (R2) | | Method | Turbidimetry | Immunoturbidimetry | | Reagent
On board Stability | 90 days | 6 weeks | | Reference range | 0.45-2.81 g/L
45-281 mg/dL | 0.4-2.30 g/L
40-230 mg/dL | | Sample Stability | 2-8°C for up to 3 days | 2 months at 20-25°C
4 months at 4-8°C
6 months at -20°C | | Sample type | Serum,
Lithium-heparin plasma
EDTA plasma | Serum
Lithium-heparin plasma | # ii. Comparison with predicate Device: Differences {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is written in a simple, sans-serif font and is left-aligned. # c. Yumizen C1200 Immunoglobulin M # i. Comparison with predicate Device : Similarities {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a smaller, gray font. The text appears to be a section heading or title, possibly from a document or report. # ii. Comparison with predicate Device: Differences # 7- Special Control/Guidance Document Referenced # a. Standards Followed : The following standards & FDA guidance documents have been used to support this submission: {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a smaller font size compared to the logo. The overall image appears to be a document header or title section. ### 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. References cited - Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745) ### 8- Device Description - a. Ig A #### . Method Immunoturbidimetric test. Endpoint determination of the concentration done by photometric measurement. It is an antigen-antibodyreaction of the antibodies with the that is present in the sample. - Reagent Yumizen C1200 Ig A Yumizen C1200 Immunoglobin A is ready-to-use. Reagent 1 (R1): TRIS pH 7.5 100 mmol/L NaCl 150 mmol/L Reagent 2 (R2): TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human IgA antibody (goat) < 1% # b. Ig G #### . Method Immunoturbidimetric test. Endpoint determination of the concentration done by photometric measurement. It is an antigen-antibodyreaction of the antibodies with the that is present in the sample. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be a heading or title for a document or section. - . Reagent Yumizen C1200 Ig G Yumizen C1200 Immunoglobin G is ready-to-use. Reagent 1 (R1): TRIS pH 7.5 100 mmol/L NaCl 150 mmol/L Reagent 2 (R2): TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human IgG antibody (goat) < 1% c. Ig M #### . Method Immunoturbidimetric test. Endpoint determination of the concentration done by photometric measurement. It is an antigen-antibody reaction of the antibodies present in the sample. . Reagent Yumizen C1200 Ig M Yumizen C1200 Immunoglobin M is ready-to-use. Reagent 1 (R1): TRIS pH 7.5 100 mmol/L NaCl 150 mmol/L Reagent 2 (R2): TRIS pH 8.0 100 mmol/L, NaCl 1150 mmol/L, Anti-human IgM antibody (goat) < 1% This submission consists in the Yumizen C1200 Immunoglobulin A (1300023881), Yumizen C1200 Immunoglobulin G (1300023883) and Yumizen C1200 Immunoglobulin M (1300023884) reagent for serum and plasma testing for Yumizen C1200 reagent. The Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer and the Yumizen C1200 Protein Cal (1300023893) for use on Yumizen C1200 Analyzer are sold separately. ### 9- Analytical Performance Characteristics ### 9.1 Measuring Range The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2. The reagent linearity was determined according to CLSI guideline EP06-A. The limit of quantitation and the linearity studies showed that claimed measuring range is appropriate. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for HORIBA Medical in blue text. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be part of a document or report. #### Yumizen C1200 Immunoglobulin A ● | | Limit of
detection | Limit of
quantitation | Linearity Evaluated | Measuring range | |----------------------------|-----------------------|--------------------------|---------------------|-------------------| | Serum | 0.009 g/L | 0.08 g/L | 0.21 - 6.60 g/L | 0.10 to 7.00 g/L | | Serum
Post-
dilution | NA | NA | NA | 7.00 to 21.00 g/L | # > Linearity The reagent linearity was determined according to CLSI guideline EP06-A. ### Description Samples used for this study are IgA spiked. The different concentrations in IgA were prepared based on the dilution of the highest concentration serum level with commercial depleted serum. Sample dilutions were assayed in quadruplicate within a single within the measuring range were used to determine linearity: | Range (mg/dL) | Slope
(95%CI) | Intercept
(95% CI) | R2 | |---------------|------------------------|---------------------------|--------| | 21 – 660 | 1.027
(1.012-1.043) | 0.004
(-0.060 – 0.051) | 0.9975 | #### ● Yumizen C1200 Immunoglobulin G | | Limit of
detection | Limit of
quantitation | Linearity Evaluated | Measuring range | |----------------------------|-----------------------|--------------------------|---------------------|--------------------| | Serum | 0.01 g/L | 0.53 g/L | 0.82 – 29.42 g/L | 0.75 to 30.00 g/L | | Serum
Post-
dilution | NA | NA | NA | 30.00 to 90.00 g/L | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a simple, sans-serif font and appears to be part of a document or report. ## > Linearity The reagent linearity was determined according to CLSI guideline EP06-A. ### Description Samples used for this study are IgG spiked. The different concentrations in IgG were prepared based on the dilution of the highest concentration serum level with commercial depleted serum. Sample dilutions were assayed in quadruplicate within a single run and samples within the measuring range were used to determine linearity: | IgG Range
(mg/dL) | Slope
(95% CI) | Intercept
(95% CI) | R2 | |----------------------|-------------------|-----------------------|--------| | 82-2942 | 0.9965 | 0.2541 | 0.9986 | | | (0.985 – 1.008) | (0.07-0.44) | | #### Yumizen C1200 Immunoglobulin M ● | | Limit of
detection | Limit of
quantitation | Linearity Evaluated | Measuring range | |----------------------------|-----------------------|--------------------------|---------------------|-------------------| | Serum | 0.01 g/L | 0.03 g/L | 0.26 - 4.16 g/L | 0.20 to 5.00 g/L | | Serum
Post-
dilution | NA | NA | NA | 5.00 to 15.00 g/L | ### > Linearity The reagent linearity was determined according to CLSI guideline EP06-A. Description Samples used for this study are IgM spiked. The different concentrations in IgM were prepared based on the dilution of the highest concentration serum level with commercial depleted serum. Sample dilutions were assayed in quadruplicate within a single within the measuring range were used to determine linearity: {16}------------------------------------------------ | IgM Range
(mg/dL) | Slope
(95% CI) | Intercept
(95% CI) | R2 | |----------------------|---------------------------|------------------------------|--------| | 26 – 416 | 1.013.
(1.001 – 1.025) | – 0.087
(-0.115 – -0.059) | 0.9994 | ## 9.2 Accuracy and Precision The acceptance criteria for the assays were: Within Run: CV limits, for the low, middle and high level are respectively 4.5 %, 3.8 % and 3 %. Total Precision: CV limits, for the low, middle and high level are respectively 6.0 %, 5.0 % and 4.0% #### . Yumizen C1200 Immunoglobulin A Repeatability (within-run precision) and Reproducibility (total precision) - Total Precision: analyzer variability - 20x2x2 study Five human sera samples and two levels of Yumizen C1200 Protein Control were tested with two replicates per run, two runs per day for 20 days on each of three analyzers (n=240 per sample). The results are summarized below: | IgA
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 | 1.17 | 0.8 | 2.9 | 0.7 | 2.0 | 3.7 | | Yumizen
C1200
Level 2
Protein
Control | 240 | 3.65 | 0.9 | 2.1 | 1.4 | 1.7 | 3.1 | | Sample 1 | 240 | 0.62 | 0.9 | 1.0 | 1.2 | 1.7 | 2.5 | | Sample 2 | 240 | 1.12 | 0.7 | 1.0 | 1.2 | 0.0 | 1.7 | | Sample 3 | 240 | 2.39 | 0.8 | 1.3 | 1.4 | 1.5 | 2.6 | | Sample 4 | 240 | 4.31 | 1.0 | 2.9 | 1.3 | 2.0 | 3.8 | | Sample 5 | 240 | 5.47 | 0.9 | 1.2 | 1.5 | 2.0 | 2.9 | The results are within the specifications {17}------------------------------------------------ - Lot to Lot variability study: 3x5x2x3 . Five human sera samples and two levels of Yumizen C1200 Protein Control were tested in triplicates per run, two runs per day for five days on each of three lots (n=90 per sample). The results are summarized below: | IgA
Sample | N | Mean (g/L) | Within-
Day
(%CV) | Between-
Day
(%CV) | Within -
Batch
(%CV) | Between-
Batch (%CV) | Total
(%CV) | |---------------------------------------------------|----|------------|-------------------------|--------------------------|----------------------------|-------------------------|----------------| | Yumizen
C1200
Level 1
Protein
Control | 90 | 1.17 | 1.0 | 0.7 | 1.2 | 0.1 | 1.2 | | Yumizen
C1200
Level 2
Protein
Control | 90 | 3.71 | 1.1 | 0.0 | 1.1 | 0.2 | 1.1 | | Sample 1 | 90 | 0.63 | 1.0 | 0.5 | 1.2 | 0.0 | 1.2 | | Sample 2 | 90 | 1.13 | 3.0 | 2.8 | 4.1 | 0.0 | 4.1 | | Sample 3 | 90 | 2.43 | 1.0 | 0.6 | 1.2 | 0.3 | 1.2 | | Sample 4 | 90 | 4.33 | 2.0 | 1.4 | 2.4 | 0.0 | 2.4 | | Sample 5 | 90 | 5.63 | 1.2 | 0.2 | 1.2 | 0.3 | 1.3 | The results are within the specifications. #### . Yumizen C1200 Immunoglobulin G - Total Precision: analyzer vari… --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K193525](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K193525) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com