(63 days)
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.
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The provided FDA 510(k) summary describes the analytical performance characteristics of the Yumizen C1200 Calcium AS and Yumizen C1200 Creatinine Jaffé reagents when used with the Yumizen C1200 clinical chemistry analyzer. The document focuses on demonstrating substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study designs based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data across several analytical characteristics. For some categories, explicit "acceptance criteria" are mentioned (e.g., CV limits for precision), while for others, the results are presented as factual measurements from the studies conducted.
Yumizen C1200 Calcium AS
| Acceptance Criteria Category | Acceptance Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Measuring Range | Determined according to CLSI EP17-A2 (Detection & Quantitation) and EP06-A (Linearity) | Serum/Plasma: - Limit of detection: 0.12 mmol/L (0.48 mg/dL) - Limit of quantitation: 0.14 mmol/L (0.57 mg/dL) - Linearity: 0.00 to 4.84 mmol/L (0.00 to 19.40 mg/dL) - Measuring range: 1.00 - 4.50 mmol/L (4.0 - 18.05 mg/dL) - Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL) Urine: - Limit of detection: 0.06 mmol/L (0.24 mg/dL) - Limit of quantitation: 0.16 mmol/L (0.64 mg/dL) - Linearity: 0.00 to 4.84 mmol/L (0.00 - 18.60 mg/dL) - Measuring range: 0.16 to 4.5 mmol/L (0.64 - 18.05 mg/dL) - Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL) |
| Precision (Serum/Plasma) | Within run (CV limits): 1.2% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels. Total precision (CV limits): 1.6% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels. | Within-Run (%CV): - Control N: 0.6% - Control P: 0.5% - Sample 1: 0.8% - Sample 2: 0.6% - Sample 3: 0.5% Total (%CV): - Control N: 1.5% - Control P: 1.4% - Sample 1: 1.7% - Sample 2: 1.6% - Sample 3: 1.8% (Note: "Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the p-value with 5% acceptable remains acceptable for all the samples tested.") |
| Precision (Urine) | Within run (CV limits): 3.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels. Total precision (CV limits): 4.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels. | Within-Run (%CV): - Control L1: 0.7% - Control L2: 0.5% - Sample 1: 1.6% - Sample 2: 0.8% - Sample 3: 0.7% - Sample 4: 0.6% - Sample 5: 0.6% Total (%CV): - Control L1: 3.8% - Control L2: 3.9% - Sample 1: 2.6% - Sample 2: 2.1% - Sample 3: 2.0% - Sample 4: 1.7% - Sample 5: 1.6% (Note: "The results are within the specifications.") |
| Interferences | Acceptable bias is +/-10% of the value without interfering substances. | Highest values for which no interferences > 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen (for serum/plasma) and additionally Glucose for urine. |
| Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.1159, Slope 0.9423, Correlation 0.997. (Plasma vs. Predicate) |
| Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.976) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.06, Slope 1, Correlation (r2) 0.976. (Native serum vs. Predicate) |
| Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Calcium (mmol/L): Intercept +0.1381, Slope 0.9436, Correlation (r2) 0.995. (Native urine vs. Predicate) |
| Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
| Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 6 weeks (on board). |
| Reference Range | Verification studies support established ranges from literature. | Serum/Plasma (Adults): 2.15 - 2.55 mmol/L (8.6 - 10.2 mg/dL) Urine (24h): Women < 250 mg/24h (< 6.24 mmol/24h), Men < 300 mg/24h (< 7.49 mmol/24h) |
Yumizen C1200 Creatinine Jaffé
| Acceptance Criteria Category | Acceptance Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Measuring Range | Determined according to CLSI EP17-A2 (Detection & Quantitation) and EP06-A (Linearity) | Serum/Plasma: - Limit of detection: 3.83 µmol/L (0.04 mg/dL) - Limit of quantitation: 20 µmol/L (0.23 mg/dL) - Linearity: 0 - 2226.59 µmol/L (0.00- 25.16 mg/dL) - Measuring range: 20 -1600 µmol/L (0.23 - 18.08 mg/dL) - Post-dilution: Up to 4800 µmol/L (54.24 mg/dL) Urine: - Limit of detection: 81.91 µmol/L (0.93 mg/dL) - Limit of quantitation: 235.61 µmol/L (2.66 mg/dL) - Linearity: 0 to 26896.10 µmol/L (0 to 303.93 mg/dL) - Measuring range: 261 to 25000 µmol/L (3 to 282.5 mg/dL) - Post-dilution: Up to 75000 µmol/L (875.5 mg/dL) |
| Precision (Serum/Plasma) | Within run (CV limit): 4.5% (low), 3.4% (middle), 1.8% (high). Total precision (CV limit): 6.0% (low), 4.5% (middle), 2.4% (high). | Within-Run (%CV): - Control N: 0.6% - Control P: 0.5% - Sample 1: 1.9% - Sample 2: 1.5% - Sample 3: 0.5% - Sample 4: 0.4% - Sample 5: 0.4% Total (%CV): - Control N: 2.1% - Control P: 2.1% - Sample 1: 3.1% - Sample 2: 2.9% - Sample 3: 2.0% - Sample 4: 1.9% - Sample 5: 2.5% (Note: "Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the p-value with 5% acceptable remains acceptable for sample 5.") |
| Precision (Urine) | Within run (CV limit): 4.5% (low), 3.8% (middle), 3.8% (high). Total precision (CV limit): 6.0% (low), 5.0% (middle), 5.0% (high). | Within-Run (%CV): - Control L1: 0.8% - Control L2: 0.5% - Sample 1: 3.4% - Sample 2: 2.1% - Sample 3: 0.8% - Sample 4: 0.8% - Sample 5: 0.7% Total (%CV): - Control L1: 2.1% - Control L2: 2.1% - Sample 1: 6.2% - Sample 2: 3.5% - Sample 3: 2.0% - Sample 4: 3.0% - Sample 5: 2.0% (Note: "Although the %CV of Total Precision is superior to the Acceptance criteria, the p-value with 5% acceptable remains acceptable for the sample 1.") |
| Interferences | Acceptable bias is +/-10% of the value without interfering substances. | Highest values for which no interferences > 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen, Glucose, Total Proteins (for serum/plasma) and additionally Glucose for urine (not listed, but implied from calcium's urine list). Note: Glucose for Creatinine urine interference is not listed in the table, but was for Calcium urine. Acetaminophen listed for Creatinine serum/plasma but not urine, similar to Calcium. |
| Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.999) suggest equivalence to predicate. | Creatinine (µmol): Intercept -7.102, Slope 1.087, Correlation 0.999. (Plasma vs. Predicate) |
| Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Creatinine (µmol/L): Intercept 9.158, Slope 0.9633, Correlation (r2) 0.995. (Native serum vs. Predicate) |
| Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Creatinine (mmol/L): Intercept -41.4, Slope 0.9483, Correlation (r2) 0.997. (Native urine vs. Predicate) |
| Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
| Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 7 days (on board). |
| Calibration Stability | At least 3 days (Predicate). | 24 hours (Candidate). (Note: Candidate's calibration stability is shorter than predicate.) |
| Reference Range | Verification studies support established ranges from literature. | Serum/Plasma: Mens: 62-106 µmol/L (7-12 mg/dL), Womens: 44-80 µmol/L (5-9 mg/dL) Urine (24h): Men: 14-26 mg/kg/day (124-230 µmol/kg/day), Women: 11-20 mg/kg/day (97-177 µmol/kg/day) |
2. Sample sizes for the test set and data provenance:
-
Yumizen C1200 Calcium AS:
- Matrix Comparison (Plasma): 108 individual plasma samples. Data provenance: Not specified (but likely from within France, given the manufacturer's location).
- Method Comparison (Serum/Plasma): 166 native serum samples. Data provenance: Not specified.
- Method Comparison (Urine): 105 native urine samples. Data provenance: Not specified.
- Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. This is for multiple runs/days/instruments. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
- Reference Range Verification (Serum/Plasma): 40 "normal samples" from blood bank.
- Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
- Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.
-
Yumizen C1200 Creatinine Jaffé:
- Matrix Comparison (Plasma): 69 individual plasma samples. Data provenance: "individual donors from blood bank." Not explicitly stated country of origin.
- Method Comparison (Serum/Plasma): 131 native samples. Data provenance: Not specified.
- Method Comparison (Urine): 148 native samples. Data provenance: Not specified.
- Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
- Reference Range Verification (Serum/Plasma): 35 "normal samples" from blood bank (Men), 25 "normal samples" from blood bank (Women).
- Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
- Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.
Data Provenance (General): The general provenance of the "individual donors from blood bank" for Matrix Comparisons (plasma) is not specified geographically. The studies are described as analytical performance evaluations, suggesting they are prospective studies conducted in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes the performance of in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The concept of "ground truth" here is tied to the accurate and precise measurement of these analytes by established laboratory methods, often against a reference method or predetermined values for controls/calibrators.
- Ground Truth Establishment: For IVD devices, "ground truth" is typically established by:
- Certified Reference Materials/Control Materials: These have assigned values determined by highly accurate reference methods or extensive inter-laboratory studies.
- Reference Methods: Highly accurate and precise analytical methods used to determine true values (e.g., isotope dilution mass spectrometry for some analytes).
- Predicate Devices: Comparison against an already cleared and widely accepted device.
- Expert Consensus/Pathology/Outcomes Data: These are generally relevant for diagnostic imaging or clinical decision support AI, not typically for quantitative chemical assays like Calcium and Creatinine.
The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this type of IVD testing. The focus is on analytical performance metrics (linearity, precision, interference, method comparison to a predicate).
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., reading medical images) is involved and multiple experts are used to reach a consensus for ground truth. This document describes the analytical performance of quantitative chemical assays, where measurements are objective.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. MRMC studies are used for evaluating diagnostic imaging or AI systems that assist human readers in interpretation. This document pertains to the analytical performance of reagents for quantitative chemical measurements, which do not involve human "readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The studies described (e.g., measuring range, precision, interference, method comparison) evaluate the performance of the reagent and instrument system in generating a quantitative value for Calcium and Creatinine. This is akin to a "standalone" performance evaluation of the reagent system itself, without human interpretation of the final result, beyond standard laboratory quality control and result review. The device output is a numerical value, not an interpretation requiring human assistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these studies is established through:
- Reference Methods/Assigned Values: For precision studies, control materials with known target values are used. For linearity, serially diluted samples or spiked samples with known concentrations are employed.
- Comparison to a Predicate Device: For method comparison, patient samples are tested on both the candidate device and a legally marketed predicate device, with the predicate serving as the reference for equivalence.
- Literature Reference Intervals: For reference range verification, the device's measurements on "normal samples" are compared against established reference intervals from scientific literature.
8. The sample size for the training set:
Not applicable. This is an IVD reagent and instrument system, not an AI/Machine Learning model that undergoes a distinct "training" phase with a large dataset in the way a medical image analysis algorithm would. The development of reagents involves chemical formulation and optimization, and instrument calibration relies on calibrator materials, not necessarily "training datasets" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable for the same reasons as point 8. The "ground truth" for calibrators (used for instrument calibration, which is analogous to "training" in the sense of setting up the system for accurate measurement) is typically established by the calibrator manufacturer using highly accurate reference methods and/or extensive certification processes. The document mentions "Yumizen C1200 Multical" as the calibrator for the candidate device.
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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
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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,
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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Image /page/4/Picture/0 description: The image shows the logo for Horiba Medical in blue font. Below the logo is the text "Section 007. 510(k) summary" in a smaller, gray font. The text appears to be a section heading or title, possibly from a document or report.
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 C1200Calcium AS | Yumizen C1200 Calcium AS reagent is a diagnostic reagent forquantitative in vitro determination of calcium in human serum, plasma andurine based on colorimetric method, using the clinical chemistry analyzer.Measurement of calcium is used in the diagnosis and treatment ofparathyroid disease, a variety of bone diseases, chronic renal disease andtetany (intermittent muscular contractions or spasms). |
| Yumizen C1200Creatinine Jaffé | Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent forquantitative in vitro determination of Creatinine in human serum, plasmaand urine based on a kinetic method using alkaline picrate (Jaffé method).Creatinine measurements are used in the diagnosis and treatment of renaldiseases, in monitoring renal dialysis, and as a calculation basis formeasuring 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 | Predicate510(k)number |
|---|---|---|---|
| Yumizen C1200Calcium AS | ABX Pentra Calcium AS CPOn ABX Pentra 400 / PentraC400 | HORIBA ABX SAS | K123171 |
| Yumizen C1200Creatinine Jaffé | ABX Pentra Creatinine 120 CPOn ABX Pentra 400/ PentraC400 | 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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b. Yumizen C1200 Calcium AS (1300047910)
i. Comparison with predicate Device : Similarities
| Item | Predicate K123171 | Candidate |
|---|---|---|
| Device Name | ABX Pentra Calcium AS CPOn 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 vitrodetermination of calcium in human serum,plasma and urine based on a colorimetricmethod, using the ABX Pentra 400Clinical Chemistry analyzer. Measurementof calcium is used in the diagnosis andtreatment of parathyroid disease, a varietyof bone diseases, chronic renal disease andtetany (intermittent muscular contractionsor spasms). | Diagnostic reagent for quantitative invitro determination of calcium in humanserum, plasma and urine based oncolorimetric method, using the clinicalchemistry analyzer. Measurement ofcalcium is used in the diagnosis andtreatment of parathyroid disease, avariety of bone diseases, chronic renaldisease and tetany (intermittent muscularcontractions 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 stableup to the expiry date on the label if storedbetween 2-8°C, protected from light | Stable up to the expiry date on the labelif stored at 2-8°C. |
| Analytical Range | Measuring RangeSerum/Plasma:4.0 - 18.05 mg/dLUrine:0.64 - 18.05 mg/dL | Measuring RangeSerum, Plasma:1.00 -4.50 mmol/Lor4.0- 18.05 mg/dLUrine:0.16 - 4.5 mmol/Lor0.64 -18.05 mg/dL |
| Item | Predicate K123171 | Candidate |
| Automatic post-dilution:Serum/plasma:up to 13.50 mmol/Lor 54.15 mg/dLwith Automatic post-dilution.Urine:up to 13.50 mmol/Lor 54.15 mg/dLwith the automatic post-dilution. | Automatic post-dilution:Serum/ Plasma:up to 13.5 mmol/Lor 54.15 mg/dLwith the automatic post-dilution.Urine:up to 13.5 mmol/Lor 54.15 mg/dLwith the automatic post-dilution. | |
| Reference range | Serum/Plasma:8.6 -10.3 mg/dLUrine :Male: <300 mg/24hFemale : <250 mg/24h | Serum/Plasma :8.6-10.2 mg/dLUrine :Men: < 300 mg/24hWomen: < 250 mg/24h |
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Image /page/7/Picture/0 description: The image shows 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."
ii. Comparison with predicate Device: Differences
| Item | Predicate K123171 | Candidate |
|---|---|---|
| Device Name | ABX Pentra Calcium AS CPOn ABX Pentra 400 / Pentra C400 | Yumizen C1200 Calcium AS(1300047910) |
| Instrument | ABX Pentra 400 / Pentra C400 | Yumizen C1200 Clinical chemistryanalyzer |
| Calibrators | ABX PENTRA Multical | Yumizen C1200 Multical |
| Controls | ABX Pentra N Control | Yumizen C1200 N Multi Control |
| ABX Pentra P Control | Yumizen C1200 P Multi Control | |
| ABX Pentra Urine Control L/H | Yumizen C1200 Urine Level 1 Control | |
| Yumizen C1200 Urine Level 2 Control | ||
| Packaging &Number of tests | Serum, plasma: 285 testsUrine : 285 tests | Serum, plasma: 6 x 290 testsUrine: 6 x 290 tests |
| On board Stability | Once opened, the reagent cassette placedin the refrigerated ABX Pentra 400compartment is stable for 70 days. | Once opened, the reagent cassette placedin the refrigerated compartment is stablefor 6 weeks. |
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Image /page/8/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is written in large, bold, blue letters. Below it, the word "Medical" is written in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name.
| Item | Predicate K123171 | Candidate |
|---|---|---|
| Discussion on the analysis differences : | ||
| 1. Instrument: Yumizen C1200 Calcium AS is used on Yumizen C1200 (See 2.) | ||
| 2. Controls: 2 separate levels of controls for Yumizen C1200 Urine Level 1 and Level 2( same for ABX Pentra) | ||
| 3. Packaging : Candidate offers more number of tests than the predicate. |
- Reagent stability: the on board stability of Yumizen C1200 Calcium AS is shorter.
Stability depends on the reagent composition and cassette capacity.
c. Yumizen C1200 Creatinine Jaffé
| Item | Predicate K110530 | Candidate | |
|---|---|---|---|
| Device Name | ABX Pentra Creatinine 120 CPOn ABX Pentra 400/ Pentra C400 | Yumizen C1200 Creatinine Jaffé(1300023842). | |
| Intended Use | Diagnostic reagent for quantitative in vitrodetermination of Creatinine in humanserum, plasma and urine based on a kineticmethod using alkaline picrate (Jaffémethod). Creatinine measurements areused in the diagnosis and treatment ofrenal diseases, in monitoring renal dialysis,and as a calculation basis for measuringother urine analytes. | Diagnostic reagent for quantitative invitro determination of Creatinine inhuman serum, plasma and urine based ona kinetic method using alkaline picrate(Jaffé method). Creatinine measurementsare used in the diagnosis and treatment ofrenal diseases, in monitoring renaldialysis, and as a calculation basis formeasuring other urine analytes. | |
| Manufactured by | HORIBA ABX SAS | HORIBA ABX SAS | |
| Sample type | Serum, plasma, urine | Same | |
| Reagent format | Liquid | Same | |
| Measurement | Quantitative | Same | |
| Method | Colorimetry | Same | |
| Analytical Range | Measuring RangeSerum/Plasma:0.22 to 18.08 mg/dLUrine:2.90 to 282.50 mg/dL | Measuring RangeSerum, plasma:20 umol/L to 1600 umol/Lor0.23 to 18.08 mg/dLUrine:261 µmol/L to 25000 µmol/Lor3 to 282.5 mg/dL | |
| Item | Predicate K110530 | Candidate | |
| Automatic post-dilution:Serum, plasma:up to 4800 µmol/L or 54.24 mg/dLwith the automatic post-dilution.Urine:up to 75000 µmol/L or 847.5 mg/dLwith the automatic post-dilution. | Automatic post-dilution:Serum, plasma:up to 4800 µmol/L or 54.24 mg/dLwith the automatic post-dilution.Urine:up to 75000 µmol/L or 847.5 mg/dLwith the automatic post-dilution. | ||
| Reference range | Serum, plasma:Men7.0 - 12.0 mg/L0.70- 1.20 µmol/L62 - 106 µmol/LWomen5.0 - 9.0 mg/L0.50-0.90 µmol/L44 - 80 µmol/LUrine (24 hours):Men14 - 26 mg/kg/day124 - 230 µmol/kg/dayWomen11 - 20 mg/kg/day97 - 177 µmol/kg | Serum, plasma:Men7.0 - 12.0 mg/L0.70- 1.20 µmol/L62 - 106 µmol/LWomen5.0 - 9.0 mg/L0.50-0.90 µmol/L44 - 80 µmol/LUrine (24 hours)Men14 - 26 mg/kg/day124 - 230 µmol/kg/dayWomen:11 - 20 mg/kg/day97 - 177 µmol/kg |
i. Comparison with predicate Device : Similarities
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Image /page/9/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is written in large, bold, blue letters. Below the word "HORIBA" is the word "Medical" written in a smaller, lighter blue font. The logo is simple and clean, with a focus on the company name.
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ii. Comparison with predicate Device: Differences
| Item | Predicate K110530 | Candidate |
|---|---|---|
| Device Name | ABX Pentra Creatinine 120 CPOn ABX Pentra 400/ Pentra C400 | Yumizen C1200 Creatinine Jaffé(1300023842). |
| Instrument | ABX Pentra 400 Clinical ChemistryAnalyzer | Yumizen C1200 Clinical chemistryanalyzer |
| Controls | ABX Pentra N Control | Yumizen C1200 N Multi Control |
| Controls | ABX Pentra P Control | Yumizen C1200 P Multi Control |
| Controls | ABX Pentra Urine Control L/H | Yumizen C1200 Urine Level 1 Control |
| Yumizen C1200 Urine Level 2 Control | ||
| Calibrators | ABX Pentra Multical | Yumizen C1200 Multical |
| Number of tests | 120 tests | 6 x 315 tests |
| Packaging | Cassette of :R1= 27.5 mLR2= 8 mL | Cassette of :R1: 6 x 32 mLR2: 6 x 11 mL |
| Sample Volume | 10 µL/test | 5.0 µL/test |
| Shelf-life | In unopened cassettes,stable up to 36 monthsif stored at 2-8°C | Stable up to the expiry date on the labelif stored at 2-8°C.Store protected from light. |
| On board Stability | Once opened, the reagent cassette placedin the refrigerated (2-8°C)ABX Pentra 400 compartment is stable:19 days | Once opened, the reagent cassette placedin the refrigerator compartment (2-8°C)is stable for :7 days |
| CalibrationStability | The reagent is calibrated on Day 0. Thecalibration stability is checked by testing 2control specimens.The calibration stability is at least 3 days. | The reagent is calibrated on Day 0. Thecalibration stability is checked by testing2 control specimens.The calibration stability is 24 hours. |
Discussion on the analysis differences :
-
Instrument: Yumizen C1200 Creatinine Jaffé is used on Yumizen C1200
-
Packaging: Yumizen C1200 Creatinine Jaffé offers more reagent per cassette including more number of tests that depends on packaging and cassette capacity.
-
Reagent stability: the on board stability of Yumizen C1200 Creatinine Jaffé is shorter but has longer shelf-life when un-opened. Stability depend on reagent composition and cassette capacity.
Calibration stability: Yumizen C1200 Creatinine Jaffé is shorter 4.
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Image /page/11/Picture/0 description: The image shows the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller, light blue letters, is the word "Medical". The logo is simple and clean, with a focus on the company name.
7 - Special Control/Guidance Document Referenced
a. Standards Followed
The following standards & FDA guidance documents have been used to support this submission:
CLSI Guidelines:
- CLSI EP05-A3:Evaluation of Precision of Quantitative Measurement Procedures- Third Edition - October 2014
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures - Second Edition - June 2012
- CLSI EP09-A3: Measurement Procedure Comparison and Biais Estimation Using Patient ● Samples- Third Edition - August 2013
- CLSI EP06-A: Evaluation of the Linearity of Quantitative measurement Procedures A Statistical Approach - First Edition - April 2003
- CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical ● laboratory- Third Edition - November 2008
- CLSI EP25-A : Evaluation of Stability of In Vitro Diagnostic reagents- First Edition-September 2009
b. FDA Guidances Followed
- Guidance for Industry and FDA Staff : Format for Traditional and Abbreviated 510(k)s - 2005
- Refuse To Accept (RTA) Policy for 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on: February 21, 2019.
- Guidance for Industry and FDA Staff : eCopy Program for Medical Device Submissions -2015
c. Others Guidances followed
- Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745)
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Traditional 510(k): Original Submission Yumizen C1200 Reagents
8- Analytical Performance Characteristics
8.1 Measuring Range
. Yumizen C1200 Calcium AS
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.
- A Results :
| Limit ofdetection | Limit of quantitation | Linearity | Measuring range | |
|---|---|---|---|---|
| Serum /plasma | 0.12 mmolor0.48 mg/dL | 0.14 mmol/Lor0.57 mg/dL | 0.00 to 4.84 mmol/Lor0.00 to 19.40 mg/dL | 1.00 - 4.50 mmol/Lor4.0 - 18.05 mg/dL |
| Serum/plasmaPost-dilution | NA | NA | Up to 13.5 mmol/Lor54.15 mg/dL | Up to 13.5 mmol/Lor54.15 mg/dL |
| Urine | 0.06 mmol/Lor0.24 mg/dL | 0.16 mmol/Lor0.64 mg/dL | 0.00 to 4.84 mmol/Lor0.00 - 18.60 mg/dL | 0.16 to 4.5 mmol/Lor0.64 - 18.05 mg/dL |
| UrinePost-dilution | NA | NA | Up to 13.5 mmol/Lor54.15 mg/dL | Up to 13.5 mmol/Lor54.15 mg/dL |
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Yumizen C1200 Creatinine Jaffé ●
The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2. The reagent linearity was determined according to CLSI guideline EP06-A. The limit of quantitation and the linearity studies showed that claimed measuring range is appropriate.
> Results :
| Limit ofdetection | Limit of quantitation | Linearity | Measuring range | |
|---|---|---|---|---|
| Serum /plasma | 3.83 µmol/Lor0.04mg/dL | 20 µmol/Lor0.23 mg/dL | 0 - 2226.59 µmol/Lor0.00- 25.16 mg/dL | 20 -1600 µmol/Lor0.23 - 18.08 mg/dL |
| Serum/plasmaPost-dilution | NA | NA | Until 4800 µmol/LorUntil 54.24 mg/dL | Until 4800 µmol/LorUntil 54.24 mg/dL |
| Urine | 81.91 µmol/Lor0.93 mg/dL | 235.61 µmol/Lor2.66 mg/dL | 0 to 26896.10 µmol/Lor0 to 303.93 mg/dL | 261 to 25000 µmol/Lor3 to 282.5 mg/dL |
| UrinePost-dilution | NA | NA | Until 75000 µmol/Lor875.5 mg/dL | Until 75000 µmol/Lor875.5 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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| Sample | N | Mean(mmol/L) | Mean(mg/dL) | Within-Run(%CV) | Between-Run(%CV) | Between-Day(%CV) | Between-Instrument(%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|---|
| Yumizen C1200N Multi Control | 240 | 2.22 | 8.91 | 0.6 | 0.8 | 1.0 | 0.0 | 1.5 |
| Yumizen C1200P 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 C1200Urine Level 1Control | 240 | 1.90 | 7.62 | 0.7 | 1.4 | 3.4 | 0.5 | 3.8 |
| Yumizen C1200Urine Level 2Control | 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-Instrument (%CV) | Total(%CV) |
|---|---|---|---|---|---|---|---|---|
| Yumizen C1200N Multi Control | 240 | 160.04 | 1.81 | 0.6 | 1.6 | 1.3 | 0.0 | 2.1 |
| Yumizen C1200P 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 C1200Urine Level 1Control | 240 | 5344 | 60.38 | 0.8 | 1.7 | 1.0 | 0.0 | 2.1 |
| Yumizen C1200Urine Level 2Control | 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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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 | |||||
| AcetylsalicylicAcid | 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 |
| AcetylsalicylicAcid | 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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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.
Urine :
Normal range Calcium
< 250 mg/24 h (6.24 mmol/24 h) Women Men < 300 mg/24 h (7.49 mmol/24 h)
Reference:
Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft: 1998. p. 231—241
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Image /page/23/Picture/0 description: The image contains the logo for HORIBA Medical. The word "HORIBA" is in large, bold, blue letters. Below it, in smaller blue letters, is the word "Medical."
Traditional 510(k): Original Submission Yumizen C1200 Reagents
● Creatinine Jaffé :
Serum/Plasma :
- " Men :
35 "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.
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
62 -106 umol/L / 7 -12 mg/dL.
Reference:
Mazzachi BC, Peake MJ, Ehrhard V. Reference range and method comparison studies for enzymatic and Jaffe creatinine assays in plasma and serum and early morning urine. Clin. Lab. (2000) 46: 53-55.
- Women :
25 "normal samples" from blood bank have been assayed with the method in evaluation. Each sample is assaved in duplicates.
Study performed on 2 different working days.
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
44 -80 umol/L / 5 -9 mg/dL.
Reference:
Mazzachi BC, Peake MJ, Ehrhard V. Reference range and method comparison studies for enzymatic and Jaffe creatinine assays in plasma and serum and early morning urine. Clin. Lab. (2000) 46: 53-55.
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Traditional 510(k): Original Submission Yumizen C1200 Reagents
Urine :
Normal range Creatinine - Urine (24 hours):
| Men | Women |
|---|---|
| 14 - 26 mg/kg/day | 11 - 20 mg/kg/day |
| 124 - 230 µmol/kg/day | 97 - 177 µmol/kg/day |
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): 2264.
8.8 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.
8.9 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.
§ 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.