(190 days)
Not Found
No
The summary describes reagents for immunoturbidimetry, a standard laboratory technique, and does not mention any AI or ML components in the device description or performance studies.
No
This device is an in vitro diagnostic reagent used to measure immunoglobulin levels, aiding in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents are for "quantitative in vitro diagnostic determination" and aid "in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents."
No
The device described is a reagent for in vitro diagnostic testing, which is a chemical substance used in a laboratory setting, not a software-only medical device.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for all three reagents (IgA, IgG, and IgM) explicitly states they are "intended for the quantitative in vitro diagnostic determination".
- Purpose of Measurement: The text describes the measurement of these immunoglobulins as aiding "in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates a diagnostic purpose.
- Use with Biological Samples: The reagents are intended for use with "serum and lithium heparin plasma," which are biological samples taken from the human body.
- Performance Studies: The description of performance studies (Measuring Range, Accuracy and Precision, Interferences, Method comparison, etc.) are typical evaluations performed for IVD devices to demonstrate their analytical performance for diagnostic use.
Therefore, the Yumizen C1200 Immunoglobulin A, G, and M reagents are all IVD devices.
N/A
Intended Use / Indications for 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 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.
Product codes
CZP, DEW, CFN
Device Description
Immuno turbidimetric test. Endpoint determination of the concentration done by photometric measurement. It is an antigen-antibody reaction of the antibodies with the that is present in the sample.
Yumizen C1200 Immunoglobin A, G, and M are 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/IgG/IgM antibody (goat)
§ 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).
0
June 26, 2020
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
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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 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. |
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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.
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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 |
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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 | ||
| 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
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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) 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 |
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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 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:
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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:
| 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 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:
| IgG
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 | 6.59 | 1.2 | 0.8 | 1.8 | 1.7 | 2.9 |
| Yumizen
C1200 Level 2
Protein 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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Image /page/18/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a light gray color. The image is simple and contains only text and a logo.
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:
| IgG
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 | 6.36 | 0.9 | 1.3 | 1.6 | 0.6 | 1.7 |
| Yumizen
C1200
Level 2
Protein
Control | 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:
| IgM
Sample | N | Mean
(g/L) | Within-
Run
(%CV) | Between-
Run
(%CV) | Between-
Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|-------------------------------------------------|-----|---------------|-------------------------|--------------------------|--------------------------|---------------------------------|----------------|
| Yumizen
C1200
Level 1
Lipid
Control | 240 | 0.88 | 0.6 | 0.9 | 1.8 | 0.0 | 2.1 |
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Image /page/19/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in a bold, sans-serif font and is colored in blue. Below the word "HORIBA" is the word "Medical" in a smaller, lighter font, also in blue. The logo is simple and clean, with a focus on the company name.
Section 007. 510(k) summary
| IgM
Sample | N | Mean
(g/L) | Within-
Run
(%CV) | Between-
Run
(%CV) | Between-
Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|-------------------------------------------------|-----|---------------|-------------------------|--------------------------|--------------------------|---------------------------------|----------------|
| Yumizen
C1200
Level 2
Lipid
Control | 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:
| IgM
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 | 0.86 | 0.8 | 1.1 | 1.4 | 0.8 | 1.6 |
| Yumizen
C1200
Level 2
Protein
Control | 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.
20
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 |
| Acetylsalicylic | ||
| Acid | 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 |
| Acetylsalicylic | ||
| Acid | 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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Image /page/21/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a smaller font size than the logo.
| 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 |
| Acetylsalicylic | ||
| Acid | 3.62 mmol/L | 65.16 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 µmol/L | 20 mg/dL |
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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Image /page/22/Picture/0 description: The image shows the HORIBA Medical logo in blue. Below the logo, the text "Section 007. 510(k) summary" is displayed in a light gray font. The text appears to be a section heading or title, possibly from a document or report.
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.
23
Image /page/23/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a simple, sans-serif font and appears to be part of a document or report.
| 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 ՀՀ | |||||
| ﻝ 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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Image /page/24/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. The text is in a smaller font size than the logo and is left-aligned.
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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Image /page/25/Picture/0 description: The image shows the logo for HORIBA Medical. Below the logo is the text "Section 007. 510(k) summary". The text is in a light gray font. The image is simple and contains only text and a logo.
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.