(63 days)
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No
The summary describes in vitro diagnostic reagents and their analytical performance characteristics, with no mention of AI or ML.
No
This device is a diagnostic reagent used for in vitro determination of specific substances in human samples, which falls under the category of diagnostic devices, not therapeutic devices. Therapeutic devices are used for treatment or prevention of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents are "diagnostic reagent for quantitative in vitro determination of calcium" and "diagnostic reagent for quantitative in vitro determination of Creatinine," and that the measurements are "used in the diagnosis and treatment of" various diseases.
No
The device is a diagnostic reagent for use with a clinical chemistry analyzer, indicating it is a chemical substance and not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states that the reagents are "diagnostic reagents for quantitative in vitro determination of calcium in human serum, plasma and urine" and "diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine". The phrase "in vitro determination" is a key indicator of an IVD.
- Purpose: The intended use describes the measurement of calcium and creatinine for the "diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany" and "in the diagnosis and treatment of renal diseases, in monitoring renal dialysis". This clearly indicates the use of the device for diagnostic purposes.
- Sample Type: The device analyzes "human serum, plasma and urine", which are biological samples typically used in in vitro diagnostic testing.
- Method: The methods described (colorimetric and kinetic method using alkaline picrate) are common techniques used in clinical chemistry analyzers for in vitro diagnostic testing.
Therefore, the information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes
CJY, CGX
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
8.1 Measuring Range
Yumizen C1200 Calcium AS
- Limit of detection: Serum/plasma: 0.12 mmol/L or 0.48 mg/dL; Urine: 0.06 mmol/L or 0.24 mg/dL
- Limit of quantitation: Serum/plasma: 0.14 mmol/L or 0.57 mg/dL; Urine: 0.16 mmol/L or 0.64 mg/dL
- Linearity: Serum/plasma: 0.00 to 4.84 mmol/L or 0.00 to 19.40 mg/dL; Serum/plasma Post-dilution: Up to 13.5 mmol/L or 54.15 mg/dL; Urine: 0.00 to 4.84 mmol/L or 0.00 - 18.60 mg/dL; Urine Post-dilution: Up to 13.5 mmol/L or 54.15 mg/dL
- Measuring range: Serum/plasma: 1.00 - 4.50 mmol/L or 4.0 - 18.05 mg/dL; Serum/plasma Post-dilution: Up to 13.5 mmol/L or 54.15 mg/dL; Urine: 0.16 to 4.5 mmol/L or 0.64 - 18.05 mg/dL; Urine Post-dilution: Up to 13.5 mmol/L or 54.15 mg/dL
Yumizen C1200 Creatinine Jaffé
- Limit of detection: Serum/plasma: 3.83 µmol/L or 0.04 mg/dL; Urine: 81.91 µmol/L or 0.93 mg/dL
- Limit of quantitation: Serum/plasma: 20 µmol/L or 0.23 mg/dL; Urine: 235.61 µmol/L or 2.66 mg/dL
- Linearity: Serum/plasma: 0 - 2226.59 µmol/L or 0.00- 25.16 mg/dL; Serum/plasma Post-dilution: Until 4800 µmol/L or Until 54.24 mg/dL; Urine: 0 to 26896.10 µmol/L or 0 to 303.93 mg/dL; Urine Post-dilution: Until 75000 µmol/L or 875.5 mg/dL
- Measuring Range: Serum/plasma: 20 -1600 µmol/L or 0.23 - 18.08 mg/dL; Serum/plasma Post-dilution: Until 4800 µmol/L or Until 54.24 mg/dL; Urine: 261 to 25000 µmol/L or 3 to 282.5 mg/dL; Urine Post-dilution: Until 75000 µmol/L or 875.5 mg/dL
8.2 Accuracy and Precision
Yumizen C1200 Calcium AS
- Serum/Plasma:
- Within run: CV limits, for the low (1.8 mmol/L), middle (2.4 mmol/L) and high level (3.4 mmol/L) are 1.2 %.
- Total precision: CV limits, for the low (1.8 mmol/L), middle (2.4 mmol/L) and high level (3.4 mmol/L) are 1.6 %.
- Results for N Multi Control (N=240): Mean 2.22 mmol/L (8.91 mg/dL), Within-Run (%CV) 0.6, Total (%CV) 1.5.
- Results for P Multi Control (N=240): Mean 3.04 mmol/L (12.21 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 1.4.
- Results for Sample 1 (N=240): Mean 1.60 mmol/L (6.41 mg/dL), Within-Run (%CV) 0.8, Total (%CV) 1.7.
- Results for Sample 2 (N=240): Mean 2.42 mmol/L (9.70 mg/dL), Within-Run (%CV) 0.6, Total (%CV) 1.6.
- Results for Sample 3 (N=240): Mean 3.66 mmol/L (14.68 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 1.8.
- Urine:
- Within run: CV limits, for the low (1.0mM), middle (2.5mM) and high level (4.0mM) are 3.0 %.
- Total precision: CV limits, for the low (1.0mM), middle (2.5mM) and high level (4.0mM) are 4.0%.
- Results for Urine Level 1 Control (N=240): Mean 1.90 mmol/L (7.62 mg/dL), Within-Run (%CV) 0.7, Total (%CV) 3.8.
- Results for Urine Level 2 Control (N=240): Mean 2.80 mmol/L (11.23 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 3.9.
- Results for Sample 1 (N=240): Mean 0.73 mmol/L (2.92 mg/dL), Within-Run (%CV) 1.6, Total (%CV) 2.6.
- Results for Sample 2 (N=240): Mean 1.53 mmol/L (6.12 mg/dL), Within-Run (%CV) 0.8, Total (%CV) 2.1.
- Results for Sample 3 (N=240): Mean 2.07 mmol/L (8.28 mg/dL), Within-Run (%CV) 0.7, Total (%CV) 2.0.
- Results for Sample 4 (N=240): Mean 3.59 mmol/L (14.40 mg/dL), Within-Run (%CV) 0.6, Total (%CV) 1.7.
- Results for Sample 5 (N=240): Mean 4.26 mmol/L (17.07 mg/dL), Within-Run (%CV) 0.6, Total (%CV) 1.6.
Yumizen C1200 Creatinine Jaffé
- Serum/Plasma:
- Within run: CV limit, for the low, middle and high level are respectively 4.5 %, 3.4 % and 1.8 %.
- Total precision: CV limit, for the low, middle and high level are respectively 6.0 %, 4.5 % and 2.4 %.
- Results for N Multi Control (N=240): Mean 160.04 µmol/L (1.81 mg/dL), Within-Run (%CV) 0.6, Total (%CV) 2.1.
- Results for P Multi Control (N=240): Mean 463.07 µmol/L (5.23 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 2.1.
- Results for Sample 1 (N=240): Mean 48.86 µmol/L (0.55 mg/dL), Within-Run (%CV) 1.9, Total (%CV) 3.1.
- Results for Sample 2 (N=240): Mean 137.77 µmol/L (1.56 mg/dL), Within-Run (%CV) 1.5, Total (%CV) 2.9.
- Results for Sample 3 (N=240): Mean 580.92 µmol/L (6.56 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 2.0.
- Results for Sample 4 (N=240): Mean 1006.9 µmol/L (11.38 mg/dL), Within-Run (%CV) 0.4, Total (%CV) 1.9.
- Results for Sample 5 (N=240): Mean 1465.33 µmol/L (16.56 mg/dL), Within-Run (%CV) 0.4, Total (%CV) 2.5.
- Urine:
- Within run: CV limit accepted, for the low, middle and high level are respectively 4.5 %, 3.8 % and 3.8 % for urine.
- Total precision: CV limit accepted, for the low, middle and high level are respectively 6.0 %, 5.0 % and 5.0 % for urine.
- Results for Urine Level 1 Control (N=240): Mean 5344 µmol/L (60.38 mg/dL), Within-Run (%CV) 0.8, Total (%CV) 2.1.
- Results for Urine Level 2 Control (N=240): Mean 13295 µmol/L (150.24 mg/dL), Within-Run (%CV) 0.5, Total (%CV) 2.1.
- Results for Sample 1 (N=240): Mean 492 µmol/L (5.56 mg/dL), Within-Run (%CV) 3.4, Total (%CV) 6.2.
- Results for Sample 2 (N=240): Mean 1020 µmol/L (11.52 mg/dL), Within-Run (%CV) 2.1, Total (%CV) 3.5.
- Results for Sample 3 (N=240): Mean 8222 µmol/L (92.91 mg/dL), Within-Run (%CV) 0.8, Total (%CV) 2.0.
- Results for Sample 4 (N=240): Mean 12692 µmol/L (143.42 mg/dL), Within-Run (%CV) 0.8, Total (%CV) 3.0.
- Results for Sample 5 (N=240): Mean 19188 µmol/L (216.83 mg/dL), Within-Run (%CV) 0.7, Total (%CV) 2.0.
8.4 Matrix comparison on predicate device
Yumizen C1200 Calcium AS
- Study materials: 108 plasma samples from individual donors, anticoagulant: heparin-lithium.
- Description: 108 plasma samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 Calcium AS reagent and with the Horiba Pentra C400 analyzer with Horiba Pentra reagent (Predicate device).
- Passing Bablok: N = 108, Min = 1.080, Max = 4.010, Intercept = 0.1159, Slope = +0.9423, Correlation = 0.997.
Yumizen C1200 Creatinine Jaffé
- Study materials: 69 plasma samples from individual donors from blood bank, anticoagulant: heparin-lithium.
- Description: 69 plasma samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 Creatinine Jaffé reagent and with the Horiba Pentra C400 analyzer with Horiba Pentra reagent (Predicate device).
- Passing Bablok: N = 69, Min = 51.400, Max = 1618.880, Intercept = -7.102, Slope = +1.087, Correlation = 0.999.
8.5 Method comparison with a predicate device
Yumizen C1200 Calcium AS
- Serum/Plasma:
- Study type: Comparison with predicate device using CLSI EP-9A3 guidance.
- Sample size: 166 native serum samples.
- Protocol: Assayed in duplicate, in ascendant order and descendant order on 6 working days.
- Passing Bablok: N = 166, Min = 1.56, Max = 4.47, Intercept = 0.06, Slope = 1, Correlation – r2 = 0.976.
- Urine:
- Study type: Comparison with predicate device using CLSI EP-9A3 guidance.
- Sample size: 105 native serum samples.
- Protocol: Assayed in duplicate, in ascendant order and descendant order on 5 working days.
- Passing Bablok: N = 105, Min = 0.27, Max = 4.3, Intercept = +0.1381, Slope = 0.9436, Correlation – r2 = 0.995.
Yumizen C1200 Creatinine Jaffé
- Serum/Plasma:
- Study type: Comparison with predicate device using CLSI EP-9A3 guidance.
- Sample size: 131 native samples.
- Protocol: Assayed in duplicate, in ascendant order and descendant order on 5 working days.
- Passing Bablok: N = 131, Min = 28.57, Max = 1233.70, Intercept = 9.158, Slope = 0.9633, Correlation – r2 = 0.995.
- Urine:
- Study type: Comparison with predicate device using CLSI EP-9A3 guidance.
- Sample size: 148 native samples.
- Protocol: Assayed in duplicate, in ascendant order and descendant order on 5 working days.
- Passing Bablok (mmol/L): N = 148, Min = 436.57, Max = 22858.07, Intercept = -41.4, Slope = +09483, Correlation - r2 = 0.997.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2019
Horiba ABX SAS Caroline Ferrer Regulatory Affairs Manager Parc Euromedecine, Rue du Caducee - BP7290 Montpellier Cedex 4, 341184 France
Re: K191396
Trade/Device Name: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Code: CJY, CGX Dated: May 22, 2019 Received: May 24, 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191396
Device Name Yumizen C1200 Calcium AS Yumizen C1200 Creatinine Jaffé
Indications for Use (Describe)
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
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Image /page/3/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter blue letters, is the word "Medical."
Traditional 510(k): Original Submission Yumizen C1200 Reagents
SECTION 007 : 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510 (k) number : K191316
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Traditional 510(k): Original Submission Yumizen C1200 Reagents
1- Date of Summary Date submitted : 22nd May, 2019 Revised Date submitted : 23rd July,2019
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 C1200 Calcium AS (1300047910) Yumizen C1200 Creatinine Jaffé (1300023842)
5- Device Name and Classification
. Intended use
The devices involved by the 510(k) submission file are the following :
. Classification and Description
| Device's names | Intended Use |
|---|---|
| Yumizen C1200 | |
| Calcium AS | Yumizen C1200 Calcium AS reagent is a diagnostic reagent for |
| quantitative in vitro determination of calcium in human serum, plasma and | |
| urine based on colorimetric method, using the clinical chemistry analyzer. | |
| Measurement of calcium is used in the diagnosis and treatment of | |
| parathyroid disease, a variety of bone diseases, chronic renal disease and | |
| tetany (intermittent muscular contractions or spasms). | |
| Yumizen C1200 | |
| Creatinine Jaffé | Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for |
| quantitative in vitro determination of Creatinine in human serum, plasma | |
| and urine based on a kinetic method using alkaline picrate (Jaffé method). | |
| Creatinine measurements are used in the diagnosis and treatment of renal | |
| diseases, in monitoring renal dialysis, and as a calculation basis for | |
| measuring other urine analytes. |
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Image /page/5/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in a smaller font, is the word "Medical" also in blue. The logo is simple and clean, with a focus on the company name.
| Yumizen C1200 Calcium AS | |
|---|---|
| Trade/Proprietary Name: | |
| Device Class: | Class II / 510(k) required |
| Classification Name: | §862.1145: Calcium test system |
| Product Code: | CJY |
| Panel: | Clinical Chemistry (75) |
| Trade/Proprietary Name: | Yumizen C1200 Creatinine Jaffé |
|---|---|
| Device Class: | Class II / 510(k) required |
| Classification Name: | §862.1225: Creatinine test system |
| Product Code: | CGX |
| Panel: | Clinical Chemistry (75) |
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.
a. Predicate Device Name and 510(k) number
| Candidate device | Predicate device | Predicate Manufacturer | Predicate
510(k)
number |
|-----------------------------------|-------------------------------------------------------------------|------------------------|-------------------------------|
| Yumizen C1200
Calcium AS | ABX Pentra Calcium AS CP
On ABX Pentra 400 / Pentra
C400 | HORIBA ABX SAS | K123171 |
| Yumizen C1200
Creatinine Jaffé | ABX Pentra Creatinine 120 CP
On ABX Pentra 400/ Pentra
C400 | HORIBA ABX SAS | K110530 |
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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Image /page/6/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a smaller, gray font. The text appears to be a section heading or title, possibly from a document or report.
b. Yumizen C1200 Calcium AS (1300047910)
i. Comparison with predicate Device : Similarities
| Item | Predicate K123171 | Candidate |
|---|---|---|
| Device Name | ABX Pentra Calcium AS CP | |
| On ABX Pentra 400 / Pentra C400 | Yumizen C1200 Calcium AS | |
| (1300047910) | ||
| Manufactured by | HORIBA ABX SAS | HORIBA ABX SAS |
| Intended Use | Diagnostic reagent for quantitative in vitro | |
| determination of calcium in human serum, | ||
| plasma and urine based on a colorimetric | ||
| method, using the ABX Pentra 400 | ||
| Clinical Chemistry analyzer. Measurement | ||
| of calcium is used in the diagnosis and | ||
| treatment of parathyroid disease, a variety | ||
| of bone diseases, chronic renal disease and | ||
| tetany (intermittent muscular contractions | ||
| or spasms). | Diagnostic reagent for quantitative in | |
| vitro determination of calcium in human | ||
| serum, plasma and urine based on | ||
| colorimetric method, using the clinical | ||
| chemistry analyzer. Measurement of | ||
| calcium is used in the diagnosis and | ||
| treatment of parathyroid disease, a | ||
| variety of bone diseases, chronic renal | ||
| disease and tetany (intermittent muscular | ||
| contractions or spasms). | ||
| Sample type | Serum, plasma, urine | Same |
| Reagent format | Liquid | Same |
| Measurement | Quantitative | Same |
| Method | Colorimetry | Same |
| Shelf-life | Reagents, in unopened cassettes, are stable | |
| up to the expiry date on the label if stored | ||
| between 2-8°C, protected from light | Stable up to the expiry date on the label | |
| if stored at 2-8°C. | ||
| Analytical Range | Measuring Range | |
| Serum/Plasma: | ||
| 4.0 - 18.05 mg/dL | ||
| Urine: | ||
| 0.64 - 18.05 mg/dL | Measuring Range | |
| Serum, Plasma: | ||
| 1.00 -4.50 mmol/L | ||
| or | ||
| 4.0- 18.05 mg/dL | ||
| Urine: | ||
| 0.16 - 4.5 mmol/L | ||
| or | ||
| 0.64 -18.05 mg/dL | ||
| Item | Predicate K123171 | Candidate |
| Automatic post-dilution: | ||
| Serum/plasma: | ||
| up to 13.50 mmol/L | ||
| or 54.15 mg/dL | ||
| with Automatic post-dilution. |
Urine:
up to 13.50 mmol/L
or 54.15 mg/dL
with the automatic post-dilution. | Automatic post-dilution:
Serum/ Plasma:
up to 13.5 mmol/L
or 54.15 mg/dL
with the automatic post-dilution.
Urine:
up to 13.5 mmol/L
or 54.15 mg/dL
with the automatic post-dilution. |
| Reference range | Serum/Plasma:
8.6 -10.3 mg/dL
Urine :
Male: Results :
| | Limit of
detection | Limit of quantitation | Linearity | Measuring range |
|---------------------------------------|-----------------------------------------|------------------------------------------|--------------------------------------------------------|------------------------------------------------------|
| Serum /
plasma | 3.83 µmol/L
or
0.04mg/dL | 20 µmol/L
or
0.23 mg/dL | 0 - 2226.59 µmol/L
or
0.00- 25.16 mg/dL | 20 -1600 µmol/L
or
0.23 - 18.08 mg/dL |
| Serum/
plasma
Post-
dilution | NA | NA | Until 4800 µmol/L
or
Until 54.24 mg/dL | Until 4800 µmol/L
or
Until 54.24 mg/dL |
| Urine | 81.91 µmol/L
or
0.93 mg/dL | 235.61 µmol/L
or
2.66 mg/dL | 0 to 26896.10 µmol/L
or
0 to 303.93 mg/dL | 261 to 25000 µmol/L
or
3 to 282.5 mg/dL |
| Urine
Post-
dilution | NA | NA | Until 75000 µmol/L
or
875.5 mg/dL | Until 75000 µmol/L
or
875.5 mg/dL |
8.2 Accuracy and Precision
Repeatability (within-run precision) and Reproducibility (total precision)
● Yumizen C1200 Calcium AS
Serum/Plasma :
Within run : CV limits, for the low (1.8 mmol/L), middle (2.4 mmol/L) and high level (3.4 mmol/L) are 1.2 % Total precision: CV limits, for the low (1.8 mmol/L), middle (2.4 mmol/L) and high level (3.4 mmol/L) are 1.6 %.
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Image /page/14/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, lighter blue letters, is the word "Medical."
| Sample | N | Mean
(mmol/L) | Mean
(mg/dL) | Within-
Run
(%CV) | Between-
Run
(%CV) | Between-
Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|----------------------------------|-----|------------------|-----------------|-------------------------|--------------------------|--------------------------|---------------------------------|----------------|
| Yumizen C1200
N Multi Control | 240 | 2.22 | 8.91 | 0.6 | 0.8 | 1.0 | 0.0 | 1.5 |
| Yumizen C1200
P Multi Control | 240 | 3.04 | 12.21 | 0.5 | 0.7 | 1.1 | 0.4 | 1.4 |
| Sample 1 | 240 | 1.60 | 6.41 | 0.8 | 0.8 | 1.1 | 0.4 | 1.7 |
| Sample 2 | 240 | 2.42 | 9.70 | 0.6 | 1.2 | 0.6 | 0.4 | 1.6 |
| Sample 3 | 240 | 3.66 | 14.68 | 0.5 | 1.1 | 1.0 | 0.8 | 1.8 |
Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the pvalue with 5% acceptable remains acceptable for all the samples tested.
Urine :
Within run : CV limits, for the low (1.0mM), middle (2.5mM) and high level (4.0mM) are 3.0 %. Total precision: CV limits, for the low (1.0mM), middle (2.5mM) and high level (4.0mM) are 4.0%.
| Sample | N | Mean
(mmol/L) | Mean
(mg/dL) | Within-
Run
(%CV) | Between-
Run
(%CV) | Between-
Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|-------------------------------------------|-----|------------------|-----------------|-------------------------|--------------------------|--------------------------|---------------------------------|----------------|
| Yumizen C1200
Urine Level 1
Control | 240 | 1.90 | 7.62 | 0.7 | 1.4 | 3.4 | 0.5 | 3.8 |
| Yumizen C1200
Urine Level 2
Control | 240 | 2.80 | 11.23 | 0.5 | 1.4 | 3.6 | 0.0 | 3.9 |
| Sample 1 | 240 | 0.73 | 2.92 | 1.6 | 1.0 | 1.8 | 0.0 | 2.6 |
| Sample 2 | 240 | 1.53 | 6.12 | 0.8 | 1.3 | 1.4 | 0.0 | 2.1 |
| Sample 3 | 240 | 2.07 | 8.28 | 0.7 | 1.5 | 1.0 | 0.0 | 2.0 |
| Sample 4 | 240 | 3.59 | 14.40 | 0.6 | 1.0 | 1.1 | 0.4 | 1.7 |
| Sample 5 | 240 | 4.26 | 17.07 | 0.6 | 0.9 | 1.2 | 0.3 | 1.6 |
The results are within the specifications.
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Yumizen C1200 Creatinine Jaffé ●
Serum/Plasma :
Within run : CV limit, for the low, middle and high level are respectively 4.5 %, 3.4 % and 1.8 %. Total precision : CV limit, for the low, middle and high level are respectively 6.0 %, 4.5 % and 2.4 %.
| Sample | N | Mean
(µmol/L) | Mean
(mg/dL) | Within-
Run
(%CV) | Between-
Run (%CV) | Between-
Day (%CV) | Between-
Instrumen
t (%CV) | Total
(%CV) |
|----------------------------------|-----|------------------|-----------------|-------------------------|-----------------------|-----------------------|----------------------------------|----------------|
| Yumizen C1200
N Multi Control | 240 | 160.04 | 1.81 | 0.6 | 1.6 | 1.3 | 0.0 | 2.1 |
| Yumizen C1200
P Multi Control | 240 | 463.07 | 5.23 | 0.5 | 1.6 | 1.1 | 0.1 | 2.1 |
| Sample 1 | 240 | 48.86 | 0.55 | 1.9 | 1.8 | 1.8 | 0.0 | 3.1 |
| Sample 2 | 240 | 137.77 | 1.56 | 1.5 | 1.5 | 1.9 | 0.0 | 2.9 |
| Sample 3 | 240 | 580.92 | 6.56 | 0.5 | 1.8 | 0.9 | 0.0 | 2.0 |
| Sample 4 | 240 | 1006.9 | 11.38 | 0.4 | 1.5 | 1.0 | 0.0 | 1.9 |
| Sample 5 | 240 | 1465.33 | 16.56 | 0.4 | 2.4 | 0.5 | 0.0 | 2.5 |
Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the pvalue with 5% acceptable remains acceptable for sample 5.
Urine :
Within run : CV limit accepted, for the low, middle and high level are respectively 4.5 %, 3.8 % and 3.8 % for urine.
Total precision : CV limit accepted, for the low, middle and high level are respectively 6.0 %, 5.0 % and 5.0 % for urine.
| Sample | N | Mean
(µmol/L) | Mean
(mg/dL) | Within-Run
(%CV) | Between-Run
(%CV) | Between-Day
(%CV) | Between-
Instrument
(%CV) | Total
(%CV) |
|-------------------------------------------|-----|------------------|-----------------|---------------------|----------------------|----------------------|---------------------------------|----------------|
| Yumizen C1200
Urine Level 1
Control | 240 | 5344 | 60.38 | 0.8 | 1.7 | 1.0 | 0.0 | 2.1 |
| Yumizen C1200
Urine Level 2
Control | 240 | 13295 | 150.24 | 0.5 | 1.6 | 1.3 | 0.0 | 2.1 |
| Sample 1 | 240 | 492 | 5.56 | 3.4 | 3.5 | 3.6 | 1.3 | 6.2 |
| Sample 2 | 240 | 1020 | 11.52 | 2.1 | 2.1 | 1.9 | 0.0 | 3.5 |
| Sample 3 | 240 | 8222 | 92.91 | 0.8 | 1.8 | 0.0 | 0.3 | 2.0 |
| Sample 4 | 240 | 12692 | 143.42 | 0.8 | 2.9 | 0.0 | 0.0 | 3.0 |
| Sample 5 | 240 | 19188 | 216.83 | 0.7 | 1.8 | 0.0 | 0.3 | 2.0 |
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Image /page/16/Picture/0 description: The image shows the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is in a smaller font size than the logo.
Although the %CV of Total Precision is superior to the Acceptance criteria, the p-value with 5% acceptable remains acceptable for the sample 1.
8.3 Interferences
The Interferences were determined according to the CLSI guideline EP07-A2. The acceptable bias is defined at +/-10% of the value without interfering substances. These data in the following table represent the highest values for which no interferences higher than 10% have been observed.
Yumizen C1200 Calcium AS ●
| Serum/plasma | |||||||
|---|---|---|---|---|---|---|---|
| Hemoglobin | 290umol/L | 500 mg/dL | |||||
| Triglycerides | 5.66 mmol/l | 495 mg/dL | |||||
| Total Bilirubin | 562 umol/L | 32.9 mg/dL | |||||
| Direct Bilirubin | 410 umol/L | 24 mg/dL | |||||
| Acetylsalicylic | |||||||
| Acid | 3.62 mmol/L | 65.16 mg/dL | |||||
| Ascorbic Acid | 340 umol/L | 5.98 mg/dL | |||||
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL | |||||
| Acetaminophen | 1324 umol/L | 20 mg/dL |
| Urine | ||
|---|---|---|
| Hemoglobin | 290 $\mu$ mol/L | 500 mg/dL |
| Triglycerides | 5.19 mmol/l | 454 mg/dL |
| Direct Bilirubin | 328 $\mu$ mol/L | 19.2 mg/dL |
| Ascorbic Acid | 340 $\mu$ mol/L | 5.98 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Glucose | 81 mmol/L | 1463.4 mg/dL |
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Image /page/17/Picture/0 description: The image shows the HORIBA Medical logo in blue, with the word "Medical" in a smaller font size below "HORIBA". Below the logo, the text "Section 007. 510(k) summary" is displayed in a gray font. The text appears to be a section heading or title, possibly from a document or report.
Yumizen C1200 Creatinine Jaffé .
| Serum/plasma | ||
|---|---|---|
| Hemoglobin | 290 µmol/L | 500 mg/dL |
| Triglycerides | 5.80 mmol/l | 507.50 mg/dL |
| Total Bilirubin | 397 µmol/L | 23.24 mg/dL |
| Direct Bilirubin | 635 µmol/L | 37.15 mg/dL |
| Acetylsalicylic | ||
| Acid | 2.72 mmol/L | 48.87 mg/dL |
| Ascorbic Acid | 255 µmol/L | 4.49 mg/dL |
| Ibuprofen | 2.43 mmol/L | 50.10 mg/dL |
| Acetaminophen | 1324 µmol/L | 20 mg/dL |
| Glucose | 38 mmol/L | 682 mg/dL |
| Total Proteins | 36 to 101 g/L |
| Urine | ||
|---|---|---|
| Hemoglobin | 290 µmol/L | 500 mg/dL |
| Triglycerides | 4.50 mmol/l | 393.75 mg/dL |
| Direct Bilirubin | 537 µmol/L | 31.39 mg/dL |
| Ascorbic Acid | 340 µmol/L | 5.98 mg/dL |
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8.4 Matrix comparison on predicate device
● Yumizen C1200 Calcium AS
Study materials :
Anticoagulant : heparin-lithium
Samples: individual donors
Description :
108 plasma samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 Calcium AS reagent and with the Horiba Pentra C400 analyzer with Horiba Pentra reagent (Predicate device).
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
|---|---|---|---|---|---|---|
| Calcium | ||||||
| (mmol/L) | 108 | 1.080 | 4.010 | 0.1159 | +0.9423 | 0.997 |
Yumizen C1200 Creatinine Jaffé ●
Study materials :
Anticoagulant : heparin-lithium Samples: individual donors from blood bank
Description:
69 plasma samples were evaluated on Yumizen C1200 analyzer using Yumizen C1200 Creatinine Jaffé reagent and with the Horiba Pentra C400 analyzer with Horiba Pentra reagent (Predicate device).
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation |
|---|---|---|---|---|---|---|
| Calcium | ||||||
| (μmol) | 69 | 51.400 | 1618.880 | -7.102 | +1.087 | 0.999 |
Conclusion :
This study shows that heparin lithium plasma samples are validated for these applications.
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Image /page/19/Picture/0 description: The image contains the HORIBA Medical logo at the top. Below the logo, the text "Section 007. 510(k) summary" is displayed. The text is written in a simple, sans-serif font and is left-aligned.
8.5 Method comparison with a predicate device
● Yumizen C1200 Calcium AS
Serum/Plasma :
This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Correlation of Calcium measurement with the Yumizen C1200 Calcium AS reagent on Yumizen C1200.
166 native serum samples have been assayed in duplicate, in ascendant order and descendant order on 6 working days.
The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation – r2 |
|---|---|---|---|---|---|---|
| Calcium (mmol/L) | 166 | 1.56 | 4.47 | 0.06 | 1 | 0.976 |
Urine :
This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Correlation of Calcium measurement with the Yumizen C1200 Calcium AS reagent on Yumizen C1200.
105 native serum samples have been assayed in duplicate, in ascendant order and descendant order on 5 working days.
The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation – r2 |
|---|---|---|---|---|---|---|
| Calcium (mmol/L) | 105 | 0.27 | 4.3 | +0.1381 | 0.9436 | 0.995 |
● Yumizen C1200 Creatinine Jaffé
Serum/Plasma :
This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Correlation of Creatinine assay with the Yumizen C1200 Creatinine Jaffé reagent on Yumizen C1200. 131 native samples have been assayed in duplicate, in ascendant order and descendant order on 5 working days.
The equation for the regression line using Passing Bablok was obtained.
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Image /page/20/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is written in a large, bold, sans-serif font and is colored in blue. Below the word "HORIBA", the word "Medical" is written in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name.
| Passing Bablok | N | Min | Max | Intercept | Slope | Correlation – r² |
|---|---|---|---|---|---|---|
| (µmol/L) | 131 | 28.57 | 1233.70 | 9.158 | 0.9633 | 0.995 |
Urine :
This study has been carried out using recommendations found in the CLSI EP-9A3 guidance. Correlation of Creatinine assay with the Yumizen C1200 Creatinine Jaffé reagent on Yumizen C1200. 148 native samples have been assayed in duplicate, in ascendant order and descendant order on 5 working days.
The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok
| (mmol/L) | N | Min | Max | Intercept | Slope | Correlation - r2 |
|---|---|---|---|---|---|---|
| 148 | 436.57 | 22858.07 | -41.4 | +09483 | 0.997 |
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Image /page/21/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, the word "Medical" is in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name.
Traditional 510(k): Original Submission Yumizen C1200 Reagents
8.6 Reagent Stability
Closed stability 8.2.1
The closed stability was determined according to the CLSI guideline EP25-A.
. Calcium :
Stability before opening:
Stable up to the expiry date on the label if stored at 2-8°C.
The shelf life claim for HORIBA Medical reagent will be 24 months.
● Creatinine Jaffé :
Stability before opening:
Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light.
The shelf life claim for HORIBA Medical reagent will be 24 months in Yumizen C1200 container.
8.6.2 Open stability
The open stability was determined according to the CLSI guideline EP25-A.
On board reagent Stability:
- The reagent stability claim for the Yumizen C1200 Calcium AS is 6 weeks
- The reagent on Board stability claim for Yumizen C1200 Creatinine Jaffé is 7 days.
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Image /page/22/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 the logo and the text.
Traditional 510(k): Original Submission Yumizen C1200 Reagents
8.7 Reference range
The Reference Range was determined according to the CLSI guideline EP28-A3.
- Calcium :
Serum/Plasma:
40 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assayed in duplicates.
Study performed on 2 different working days: 20 samples / day.
The mean of the duplicate 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
Normal range - Calcium
Adults: 2.15 - 2.55 mmol/L / 8.6 - 10.2 mg/dL.
Reference:
Roberts WL, McMillin GA, Burtis CA, Bruns DE. Reference Information for the Clinical Laboratory, TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics. 4th Ed; Burtis CA, Ashwood ER, Bruns
DE, (Elsevier Saunders eds. St Louis, USA), (2006): 2258.