(190 days)
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.
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.
This document describes the analytical performance characteristics of the Yumizen C1200 Immunoglobulin A, G, and M reagents, intended for quantitative in vitro diagnostic determination of immunoglobulins in serum and lithium heparin plasma. The study aims to demonstrate that the device meets acceptance criteria for various analytical parameters, ensuring its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Yumizen C1200 Immunoglobulin A Performance | Yumizen C1200 Immunoglobulin G Performance | Yumizen C1200 Immunoglobulin M Performance |
|---|---|---|---|---|
| Measuring Range | Appropriateness supported by LOD, LOQ, and linearity studies. | Serum: 0.10 to 7.00 g/L(Post-dilution): 7.00 to 21.00 g/L(Linearity Range): 0.21 - 6.60 g/L (Slope 1.027, R^2 0.9975) | Serum: 0.75 to 30.00 g/L(Post-dilution): 30.00 to 90.00 g/L(Linearity Range): 0.82 – 29.42 g/L (Slope 0.9965, R^2 0.9986) | Serum: 0.20 to 5.00 g/L(Post-dilution): 5.00 to 15.00 g/L(Linearity Range): 0.26 - 4.16 g/L (Slope 1.013, R^2 0.9994) |
| Precision | Within-Run CV: Low (≤4.5%), Middle (≤3.8%), High (≤3%)Total Precision CV: Low (≤6.0%), Middle (≤5.0%), High (≤4.0%) | Total Precision (Analyzer Variability): Control Level 1: 3.7%Control Level 2: 3.1%Samples: 1.7%-3.8% Lot-to-Lot Variability: Control Level 1: 1.2%Control Level 2: 1.1%Samples: 1.2%-4.1% | Total Precision (Analyzer Variability): Control Level 1: 2.9%Control Level 2: 3.3%Samples: 1.8%-3.0% Lot-to-Lot Variability: Control Level 1: 1.7%Control Level 2: 1.9%Samples: 1.4%-2.3% | Total Precision (Analyzer Variability): Control Level 1: 2.1%Control Level 2: 1.8%Samples: 1.3%-2.4% Lot-to-Lot Variability: Control Level 1: 1.6%Control Level 2: 1.7%Samples: 1.0%-2.7% |
| Interferences | Acceptable bias: +/-10% of value without interfering substances | Reported highest values for which no interferences >10% were observed for various substances (Hemoglobin, Triglycerides, Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen). | Reported highest values for which no interferences >10% were observed for various substances (Hemoglobin, Triglycerides, Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen). | Reported highest values for which no interferences >10% were observed for various substances (Hemoglobin, Triglycerides, Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen). |
| Matrix Comparison | No significant difference between serum and heparinized plasma specimens (implied by correlation and slope close to 1). | IgA: N=62 (paired serum/heparin plasma)Slope: 1.000Correlation: 0.999 | IgG: N=43 (paired serum/heparin plasma)Slope: 0.9929Correlation: 0.988 | IgM: N=43 (paired serum/heparin plasma)Slope: 1.000Correlation: 0.999 |
| Method Comparison | Demonstrated substantial equivalence through correlation with predicate device. | IgA: N=190 (native serum samples)Slope: 0.9941Correlation: 0.993 | IgG: N=214 (native serum samples)Slope: 1.016Correlation: 0.993 | IgM: N=153 (native serum samples)Slope: 1.005Correlation: 0.993 |
| Reagent Stability | Shelf life and on-board stability for opened reagents. | Closed: 24 months at 2-8°COn-Board (Opened): 6 weeks | Closed: 24 months at 2-8°COn-Board (Opened): 6 weeks | Closed: 24 months at 2-8°COn-Board (Opened): 6 weeks |
| Reference Range | Verification studies support established ranges through literature. | 0.70 - 4.00 g/L (70 - 400 mg/dL) | 7 – 16 g/L (700 - 1600 mg/dL) | 0.40 - 2.30 g/L (40 - 230 mg/dL) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Measuring Range (Linearity):
- IgA, IgG, IgM: Samples were "spiked" to create different concentrations, then serially diluted. The exact number of initial samples for spiking is not specified, but dilutions were "assayed in quadruplicate within a single run."
- Precision (Total Precision: analyzer variability - 20x2x2 study):
- IgA, IgG, IgM: 5 human sera samples and 2 levels of Yumizen C1200 Protein Control. Tested with "two replicates per run, two runs per day for 20 days on each of three analyzers" (n=240 per sample).
- Precision (Lot to Lot variability study: 3x5x2x3):
- IgA, IgG, IgM: 5 human sera samples and 2 levels of Yumizen C1200 Protein Control. Tested in "triplicates per run, two runs per day for five days on each of three lots" (n=90 per sample).
- Interferences: The exact sample size is not stated, but the study implies testing samples with varying concentrations of interfering substances to determine acceptable bias.
- Matrix Comparison:
- IgA: 62 paired samples (serum and heparinized plasma) from single donors.
- IgG: 45 paired samples (serum and heparinized plasma) from single donors. Of these, 43 were used for correlation analysis.
- IgM: 43 paired samples (serum and heparinized plasma) from single donors.
- Method Comparison:
- IgA: 190 "native samples" from human serum.
- IgG: 214 "native samples" from human serum.
- IgM: 153 "native samples" from human serum.
Data Provenance: The human serum samples used for precision, matrix comparison, and method comparison studies were "anonymous remnants of human serum specimens collected from blood bank." "Spiked" samples were used for linearity studies, and "normal samples" from a blood bank were used for reference range verification. The document does not explicitly state the country of origin, but the manufacturer is based in France. The studies appear to be prospective analytical performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned for establishing ground truth in these analytical performance studies. The studies rely on established CLSI guidelines for evaluation and comparison with a legally marketed predicate device. The ground truth for quantitative measurements is the direct measurement by the devices themselves and comparison against predicate devices or known spiked concentrations.
4. Adjudication Method for the Test Set
Not applicable. These are analytical performance studies for an in vitro diagnostic device, not studies involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the analytical performance of an in vitro diagnostic reagent and analyzer system, not a device requiring human interpretation for diagnostic purposes where MRMC studies would typically be conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this can be considered a standalone performance study. The Yumizen C1200 system (reagents and analyzer) performs the quantitative determination of immunoglobulins. The studies evaluate the analytical capabilities of the system itself, such as accuracy (via method comparison, linearity), precision, interference, and stability, without direct human intervention in the result generation or diagnostic interpretation loop. The intent is to demonstrate the device's ability to accurately measure predefined analytes.
7. Type of Ground Truth Used
The ground truth for these analytical performance studies is established through:
- Known concentrations: For linearity studies, spiked samples with known concentrations were used.
- Predicate device measurements: For method comparison, results from the candidate device were compared against measurements obtained from legally marketed predicate devices (Beckman Coulter's Olympus IgA, IgG, IgM reagents on AU analyzers).
- CLSI guidelines and established methodologies: The studies adhere to CLSI guidelines (e.g., EP05-A3 for precision, EP17-A2 for detection capability, EP06-A for linearity, EP25-A for stability, C28-A3 for reference intervals, EP-9A3 for method comparison) which define accepted methods for evaluating analytical performance and establishing performance characteristics.
- Literature-established reference ranges: For reference range verification, the device's measurements on "normal" samples were compared against ranges cited in scientific literature (e.g., Dati et al., 1996).
8. Sample Size for the Training Set
The document does not explicitly delineate a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic reagent and analyzer system, not an AI/ML-based diagnostic algorithm that typically undergoes a distinct training phase with a dedicated dataset. The performance studies described here are for analytical validation rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this in vitro diagnostic device. The analytical evaluations described involve testing the reagent and instrument system, not training a learning algorithm.
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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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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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) |
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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.
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- 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 C1200Immunoglobulin A | Yumizen C1200 Immunoglobulin A reagent is intended for thequantitative in vitro diagnostic determination of Immunoglobulin A (IgA)in serum and lithium heparin plasma by immunoturbidimetry on Yumizenanalyzers. Measurement of this immunoglobulin aids in the diagnosis ofabnormal protein metabolism and the body's lack of ability to resistinfectious agents. This test should be used in conjunction with otherlaboratory and clinical findings. |
| Yumizen C1200Immunoglobulin G | Yumizen C1200 Immunoglobulin G reagent is intended for thequantitative in vitro diagnostic determination of Immunoglobulin G (IgG)in serum and lithium heparin plasma by immunoturbidimetry on Yumizenanalyzers. Measurement of this immunoglobulin aids in the diagnosis ofabnormal protein metabolism and the body's lack of ability to resistinfectious agents. This test should be used in conjunction with otherlaboratory and clinical findings. |
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Section 007. 510(k) summary
| Yumizen C1200Immunoglobulin M | Yumizen C1200 Immunoglobulin M reagent is intended for thequantitative in vitro diagnostic determination of Immunoglobulin M (IgM)in serum and lithium heparin plasma by immunoturbidimetry on Yumizenanalyzers. Measurement of this immunoglobulin aids in the diagnosis ofabnormal protein metabolism and the body's lack of ability to resistinfectious agents. This test should be used in conjunction with otherlaboratory 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.
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Predicate Device Name and 510(k) number:
| Candidate device | Predicate device | Predicate Manufacturer | Predicate510(k)number |
|---|---|---|---|
| Yumizen C1200Immunoglobulin A | Olympus IgA reagent(OSR6X171) | BECKMAN COULTER | K073489 |
| Yumizen C1200Immunoglobulin G | Olympus IgG reagent(OSR6X172) | BECKMAN COULTER | K073490 |
| Yumizen C1200Immunoglobulin 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 quantitativedetermination of IgA immunoglobulins inhuman serum and plasma on BeckmanCoulter AU analyzers.The spectrum of abnormalities in serumimmunoglobulin concentrations is broad.Abnormal concentrations range from avirtual absence of one or more of the threemajor classes of immunoglobulin (IgG,IgA, and IgM) to polyclonal increases inone or more immunoglobulins.Measurement of these immunoglobulinsaids in the diagnosis of abnormal proteinmetabolism and the body's lack of abilityto resist infectious agents.For in vitro diagnostic use. | Yumizen C1200 Immunoglobulin Areagent is intended for the quantitative invitro diagnostic determination ofImmunoglobulin A (IgA) in serum andlithium heparin plasma byimmunoturbidimetry on Yumizenanalyzers. Measurement of thisimmunoglobulin aids in the diagnosis ofabnormal protein metabolism and thebody's lack of ability to resist infectiousagents. This test should be used inconjunction with other laboratory andclinical findings. |
| Reagent format | Liquid | Same |
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Section 007. 510(k) summary
| Item | Predicate K073489 | Candidate |
|---|---|---|
| Measurement | Quantitative | Same |
| Analytical Range | Measuring Range0.1 - 7.00 g/dL10-700 mg/L | Measuring Range0.10 - 7.00 g/dL10-700 mg/L |
ii. Comparison with predicate Device: Differences
| Item | Predicate K073489 | Candidate | |
|---|---|---|---|
| Device Name | OSR6X171 | Yumizen C1200 Immunoglobulin A(1300023881) | |
| Instrument | Olympus AU400 Clinical ChemistryAnalyzer | Yumizen C1200 Clinical chemistryAnalyzer | |
| 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 | |
| ReagentOn board Stability | 60 days | 6 weeks | |
| Reference range | 66-433 mg/dL0.66-4.33 g/L | 70-400 mg/dL0.70-4.00 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°C8 months at 4-8°C8 months at -20°C | |
| Sample type | Serum,Lithium-heparin plasmaEDTA plasma | SerumLithium-heparin plasma |
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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
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| Item | Predicate K073490 | Candidate |
|---|---|---|
| Device Name | OSR6X172 | Yumizen C1200 Immunoglobulin G(1300023883) |
| Instrument | Olympus AU400 Clinical ChemistryAnalyzer | Yumizen C1200 Clinical chemistryAnalyzer |
| 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 |
| ReagentOn board Stability | 90 days | 6 weeks |
| Reference range | 635-1741 mg/dL6.35-17.41 g/L | 700-1600 mg/dL7-16 g/L |
| Sample Stability | 2-8°C for up to 3 days | 1 week at 20-25°C3 months at 4-8°C>6 months at -20°C |
| Sample type | Serum,Lithium-heparin plasmaEDTA | SerumLithium-heparin plasma |
| Item | Predicate K073487 | Candidate |
| Device Name | OSR6X173 | Yumizen C1200 Immunoglobulin M(1300023884) |
| Intended Use | System reagent for the quantitativedetermination of IgM immunoglobulins inhuman serum and plasma on BeckmanCoulter AU analyzers.System reagent for the quantitativedetermination of IgM immunoglobulins inhuman serum and plasma on BeckmanCoulter AU analyzersThe spectrum of abnormalities in serumimmunoglobulin concentrations is broad.Abnormal concentrations range from avirtual absence of one or more of the threemajor classes of immunoglobulin (IgA,IgG, and IgM) to polyclonal increases inone or more immunoglobulins.Measurement of these immunoglobulinsaids in the diagnosis of abnormal proteinmetabolism and the body's lack of abilityto resist infectious agents.For in vitro diagnostic use. | Yumizen C1200 Immunoglobulin Mreagent is intended for the quantitative invitro diagnostic determination ofImmunoglobulin M (IgM) in serum andlithium heparin plasma byimmunoturbidimetry on Yumizenanalyzers. Measurement of thisimmunoglobulin aids in the diagnosis ofabnormal protein metabolism and thebody's lack of ability to resist infectiousagents.This test should be used in conjunctionwith other laboratory and clinicalfindings. |
| Reagent format | Liquid | Same |
| Measurement | Quantitative | Same |
| Procode | CFN | Same |
| Shelf-life | Stable up to expiry date on the label ifstored at 2-8°C. | Stable up to expiry date on the label ifstored at 2-8°C.Store protected fromlight. |
| Analytical Range | Measuring Range0.20-5.00 g/L20-500 mg/dL | Measuring Range0.20-5.00 g/L20-500 mg/dL |
| Item | Predicate K073487 | Candidate |
| Device Name | OSR6X173 | Yumizen C1200 Immunoglobulin M(1300023884) |
| Instrument | Olympus AU400 Clinical ChemistryAnalyzer | Yumizen C1200 Clinical chemistryAnalyzer |
| Manufactured by | BECKMAN COULTER | HORIBA ABX SAS |
| Packaging | 4x14mL (R1)4x11 mL (R2) | 6x20 mL (R1)6x20 mL (R2) |
| Method | Turbidimetry | Immunoturbidimetry |
| ReagentOn board Stability | 90 days | 6 weeks |
| Reference range | 0.45-2.81 g/L45-281 mg/dL | 0.4-2.30 g/L40-230 mg/dL |
| Sample Stability | 2-8°C for up to 3 days | 2 months at 20-25°C4 months at 4-8°C6 months at -20°C |
| Sample type | Serum,Lithium-heparin plasmaEDTA plasma | SerumLithium-heparin plasma |
ii. Comparison with predicate Device: Differences
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c. Yumizen C1200 Immunoglobulin M
i. Comparison with predicate Device : Similarities
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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:
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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.
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- . 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.
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Yumizen C1200 Immunoglobulin A ●
| Limit ofdetection | Limit ofquantitation | 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 |
| SerumPost-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 ofdetection | Limit ofquantitation | 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 |
| SerumPost-dilution | NA | NA | NA | 30.00 to 90.00 g/L |
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> 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 ofdetection | Limit ofquantitation | 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 |
| SerumPost-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:
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| 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:
| IgASample | N | Mean(g/L) | Within-Run(%CV) | Between-Run(%CV) | Between-Day(%CV) | Between-Instrument(%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 1ProteinControl | 240 | 1.17 | 0.8 | 2.9 | 0.7 | 2.0 | 3.7 |
| YumizenC1200Level 2ProteinControl | 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
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- 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:
| IgASample | N | Mean (g/L) | Within-Day(%CV) | Between-Day(%CV) | Within -Batch(%CV) | Between-Batch (%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 1ProteinControl | 90 | 1.17 | 1.0 | 0.7 | 1.2 | 0.1 | 1.2 |
| YumizenC1200Level 2ProteinControl | 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 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:
| IgGSample | N | Mean(g/L) | Within-Run(%CV) | Between-Run(%CV) | Between-Day(%CV) | Between-Instrument(%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200 Level 1Protein Control | 240 | 6.59 | 1.2 | 0.8 | 1.8 | 1.7 | 2.9 |
| YumizenC1200 Level 2Protein Control | 240 | 18.85 | 1.8 | 0.4 | 2.3 | 1.4 | 3.3 |
| Sample 1 | 240 | 3.14 | 1.1 | 0.5 | 1.1 | 1.8 | 2.4 |
| Sample 2 | 240 | 5.41 | 1.4 | 0.5 | 1.0 | 0.0 | 1.8 |
| Sample 3 | 240 | 10.27 | 1.5 | 0.4 | 1.5 | 1.3 | 2.5 |
| Sample 4 | 240 | 17.21 | 1.7 | 0.2 | 1.4 | 0.9 | 2.4 |
| Sample 5 | 240 | 22.36 | 2.1 | 0.0 | 1.8 | 1.1 | 3.0 |
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The results are within the specifications.
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 lot (n=90 per sample). The results are summarized below:
| IgGSample | N | Mean (g/L) | Within-Day(%CV) | Between-Day(%CV) | Within -Batch(%CV) | Between-Batch (%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 1ProteinControl | 90 | 6.36 | 0.9 | 1.3 | 1.6 | 0.6 | 1.7 |
| YumizenC1200Level 2ProteinControl | 90 | 18.21 | 1.3 | 1.3 | 1.8 | 0.4 | 1.9 |
| Sample 1 | 90 | 3.06 | 1.2 | 1.7 | 2.0 | 1.0 | 2.3 |
| Sample 2 | 90 | 5.30 | 1.2 | 0.8 | 1.4 | 0.8 | 1.6 |
| Sample 3 | 90 | 9.94 | 1.0 | 0.8 | 1.3 | 1.0 | 1.6 |
| Sample 4 | 90 | 16.66 | 1.3 | 1.1 | 1.7 | 1.1 | 2.0 |
| Sample 5 | 90 | 21.84 | 1.1 | 0.9 | 1.4 | 0.4 | 1.4 |
The results are within the specifications.
Yumizen C1200 Immunoglobulin M ●
- 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:
| IgMSample | N | Mean(g/L) | Within-Run(%CV) | Between-Run(%CV) | Between-Day(%CV) | Between-Instrument(%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 1LipidControl | 240 | 0.88 | 0.6 | 0.9 | 1.8 | 0.0 | 2.1 |
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Section 007. 510(k) summary
| IgMSample | N | Mean(g/L) | Within-Run(%CV) | Between-Run(%CV) | Between-Day(%CV) | Between-Instrument(%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 2LipidControl | 240 | 2.73 | 0.6 | 0.8 | 1.2 | 0.9 | 1.8 |
| Sample 1 | 240 | 0.56 | 0.9 | 0.8 | 2.5 | 0.3 | 2.4 |
| Sample 2 | 240 | 1.20 | 0.5 | 0.6 | 1.4 | 0.6 | 1.7 |
| Sample 3 | 240 | 1.61 | 0.5 | 0.5 | 1.0 | 0.7 | 1.4 |
| Sample 4 | 240 | 2.09 | 0.6 | 0.5 | 1.0 | 0.4 | 1.3 |
| Sample 5 | 240 | 4.43 | 0.7 | 0.8 | 0.7 | 1.3 | 1.8 |
The results are within the specifications.
- 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 lot (n=90 per sample). The results are summarized below:
| IgMSample | N | Mean (g/L) | Within-Day(%CV) | Between-Day(%CV) | Within -Batch(%CV) | Between-Batch (%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|
| YumizenC1200Level 1ProteinControl | 90 | 0.86 | 0.8 | 1.1 | 1.4 | 0.8 | 1.6 |
| YumizenC1200Level 2ProteinControl | 90 | 2.76 | 1.0 | 0.8 | 1.3 | 1.1 | 1.7 |
| Sample 1 | 90 | 0.53 | 1.0 | 0.8 | 1.3 | 2.4 | 2.7 |
| Sample 2 | 90 | 1.19 | 0.8 | 0.3 | 0.9 | 0.5 | 1.0 |
| Sample 3 | 90 | 1.60 | 0.7 | 0.5 | 0.9 | 0.6 | 1.1 |
| Sample 4 | 90 | 2.09 | 0.9 | 0.4 | 1.0 | 1.0 | 1.4 |
| Sample 5 | 90 | 4.44 | 1.2 | 0.8 | 1.4 | 1.0 | 1.8 |
The results are within the specifications.
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9.3 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.
| Serum | ||
|---|---|---|
| Hemoglobin | 290 $ \u03bcmol/L $ | 500 mg/dL |
| Triglycerides | 6.07 mmol/L | 531.13 mg/dL |
| Total Bilirubin | 500 $ \u03bcmol/l $ | 29.25 mg/dL |
| Direct Bilirubin | 389 $ \u03bcmol/l $ | 22.76 mg/dL |
| Ascorbic Acid | 340 $ \u03bcmol/L $ | 5.98 mg/dL |
| AcetylsalicylicAcid | 3.62 mmol/L | 65.16 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 $ \u03bcmol/L $ | 20 mg/dL |
Yumizen C1200 Immunoglobulin A .
Yumizen C1200 Immunoglobulin G ●
| Serum | ||
|---|---|---|
| Hemoglobin | 290 $\mu$ mol/L | 500 mg/dL |
| Triglycerides | 5.22 mmol/L | 456.75 mg/dL |
| Total Bilirubin | 668 $\mu$ mol/L | 39.05 mg/dL |
| Direct Bilirubin | 314 $\mu$ mol/L | 18.36 mg/dL |
| Ascorbic Acid | 340 $\mu$ mol/L | 5.98 mg/dL |
| AcetylsalicylicAcid | 3.62 mmol/L | 65.16 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 $\mu$ mol/L | 20 mg/dL |
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| Serum | ||
|---|---|---|
| Hemoglobin | 145 μmol/l | 250 mg/dL |
| Triglycerides | 5.95 mmol/L | 520.63 mg/dL |
| Total Bilirubin | 477 µmol/l | 27.88 mg/dL |
| Direct Bilirubin | 223 µmol/l | 13.06 mg/dL |
| Ascorbic Acid | 340 µmol/L | 5.98 mg/dL |
| AcetylsalicylicAcid | 3.62 mmol/L | 65.16 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 µmol/L | 20 mg/dL |
Yumizen C1200 Immunoglobulin M ●
9.4 Matrix comparison on predicate device
● Yumizen C1200 Immunoglobulin A
Description:
62 samples were evaluated in duplicate on Yumizen C1200 analyzer using Yumizen C1200 IgA reagent. For this study, each paired samples (sera and heparinized plasma) has been obtained from single donor.
| Immunoglobulin A (IgA, g/L) | ||||||
|---|---|---|---|---|---|---|
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
| Serum | 62 | 0.32 | 5.43 | 0.000 | 1.000 | 0.999 |
| Heparin Plasma | 5.44 |
Conclusion :
The results show there is not significant difference between serum specimens and plasma with heparin specimens.
● Yumizen C1200 Immunoglobulin G
Description:
45 samples were evaluated in duplicate on Yumizen C1200 analyzer using Yumizen C1200 IgG reagent. For this study, each paired samples (sera and heparinized plasma) has been obtained from single donor.
| Immunoglobulin G (IgG, g/L) | ||||||
|---|---|---|---|---|---|---|
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
| Serum | 43 | 8.10 | 17.06 | 0.1703 | 0.9929 | 0.988 |
| Heparin Plasma | 8.26 | 16.95 |
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Conclusion :
The results show there is no significative difference between serum specimens and plasma with heparin specimens.
● Yumizen C1200 Immunoglobulin M
Description of Test Procedure/Method
43 samples were evaluated on Yumizen C1200 analyser using Yumizen C1200 Immunoglobulin M reagent. For this study, each paired samples (sera and heparinized plasma) has been obtained from single donor.
| Immunoglobulin M (IgM, g/L) | ||||||
|---|---|---|---|---|---|---|
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
| Serum | 43 | 0.29 | 2.80 | -0.01 | 1.000 | 0.999 |
| Plasma | 0.29 | 2.78 |
Conclusion
The results show there is no significative difference between serum specimens and plasma with heparin specimens.
9.5 Method comparison with a predicate device
. Yumizen C1200 Immunoglobulin A
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.
129 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 | Min | Max | Intercept | Slope | Correlation | |
|---|---|---|---|---|---|---|
| َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ َ | 190 | 6.91 | 0.02379 | 0.9941 | 0.993 |
● Yumizen C1200 Immunoglobulin G
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.
214 native samples have been assayed in duplicate, in ascendant order and descendant order on 10 working days. Only the first replicate of each method will be used for the data analysis reported below.
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| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation - r2 |
|---|---|---|---|---|---|---|
| (g/L) | 214 | 0.96 | 28.94 | -0.1629 | 1.016 | 0.993 |
● Yumizen C1200 Immunoglobulin M
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.
153 native samples have been assayed in duplicate, in ascendant order and descendant order on 8 working days. Only the first replicate of each method will be used for the data analysis reported below.
| Passing Bablok | Min | Max | Intercept | Slope | Correlation - 1 | |
|---|---|---|---|---|---|---|
| (g/L | 1 ՀՀﻝ ﻟﯿﻨﮉ ﮐﺎ ﺭﻗﺒﮧ 1 ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩﯼ ﻓﮩﺮﺳﺖ ﺁﺑﺎﺩ ﻓﮩﺮﺳﺖ ﺁﺑﺎﺩ ﺍﯾﺮﺍﻥ ﻓﮩﺮﺳﺖ ﺁﺑﺎﺩ ﻓﺮﺍﻧﺴﯿﺴﯽ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ | 0.25 | 1 4.41 | 0.005113 | 1.005 | 0.993 |
9.6 Reagent Stability
Closed stability 9.6.1
The closed stability was determined according to the CLSI guideline EP25-A.
. Immunoglobulin A
Stability before opening: Stable up to the expiry date on the label if stored at 2-8°C. The Shelf Life of Yumizen C1200 Immunoglobulin A is 24 months.
Immunoglobulin G .
Stability before opening: Stable up to the expiry date on the label if stored at 2-8°C. The Shelf Life of Yumizen C1200 Immunoglobulin G is 24 months.
. Immunoglobulin M
Stability before opening: Stable up to the expiry date on the label if stored at 2-8°C. The Shelf Life of Yumizen C1200 Immunoglobulin M is 24 months.
8.6.2 Open stability
The open stability was determined according to the CLSI guideline EP25-A.
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On board reagent Stability:
- Yumizen C1200 Immunoglobulin A: The stability claim after opening, on-Board, is 6 weeks.
- Yumizen C1200 Immunoglobulin G: The stability claim after opening, on-Board, is 6 weeks.
- . Yumizen C1200 Immunoglobulin M: The stability claim after opening, on-Board, is 6weeks.
9.7 Reference range
The Reference Range was determined according to the CLSI guideline EP28-A3.
- . Ig A
58 "normal samples" (22 women + 36 men) from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates.
The first replicate results for each subject was compared against reference ranges cited in literature. The verification studies support in the following reference ranges which were established through literature.
0.70 - 4.00 g/l (70 - 400 mg/dl) based on CRM_DA470
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 the IFCC/BCR/CAP reference material (CRM 470). Eur. J. Clin. Chem. Clin. Biochem. (1996) 34: 517-20.
- . Ig G
44 "normal samples" (16 women + 28 men) from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates.
The first replicate results for each subject was compared against reference ranges cited in literature. The verification studies support in the following reference ranges which were established through literature.
7 – 16 g/l (700 -1600 mg/dl) based on CRM DA470
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 the IFCC/BCR/CAP reference material (CRM 470). Eur. J.Clin. Chem. Clin. Biochem. (1996) 34: 517-20.:
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K193525 Yumizen C1200 Reagents
● Ig M
74 "normal samples" (29 women + 45 men) from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates.
The first replicate results for each subject was compared against reference ranges cited in literature. The verification studies support in the following reference ranges which were established through literature.
0.40 - 2.30 g/l (40 - 230 mg/dl) based on CRM_DA470
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 the IFCC/BCR/CAP reference material (CRM 470). Eur. J. Clin. Chem. Clin. Biochem. (1996) 34: 517-20.
10. Proposed Labeling
The labeling is written as per the recommendations given in standard EN18113-2. It takes into account the requirements of 21 CFR Part 809.10.
11. Conclusions for Performance Testing
The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that each device is substantially equivalent to its predicate device.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).