(85 days)
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from validation studies) | Reported Device Performance (Randox Calcium (Ca)) |
|---|---|---|
| Precision (Serum) | Total CV% for Serum: | Lot 1: Level 1: 4.1%, Level 2: 3.6%, Level 3: 3.7%, Level 4: 3.7% |
| - Level 1: ≤ 4.2% (based on predicate value) | Lot 2: Level 1: 4.2%, Level 2: 4.2%, Level 3: 4.1%, Level 4: 4.0% | |
| - Level 2: ≤ 4.2% (based on predicate value) | ||
| - Level 3: ≤ 4.1% (based on predicate value) | ||
| - Level 4: ≤ 4.0% (based on predicate value) | ||
| Precision (Urine) | Total CV% for Urine: | Lot 1: Level 1: 4.6%, Level 2: 4.0%, Level 3: 4.0%, Level 4: 3.9% |
| - Level 1: ≤ 4.0% (based on predicate value) | Lot 2: Level 1: 4.0%, Level 2: 4.1%, Level 3: 4.0%, Level 4: 3.7% | |
| - Level 2: ≤ 4.1% (based on predicate value) | ||
| - Level 3: ≤ 4.0% (based on predicate value) | ||
| - Level 4: ≤ 3.7% (based on predicate value) | ||
| Linearity (Serum) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 16 mg/dL | Lot 1: 1.0 - 16 mg/dL; Lot 2: 1.0 - 16 mg/dL | |
| Linearity (Urine) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 32 mg/dL | Lot 1: 1.0 - 32 mg/dL; Lot 2: 1.0 - 32 mg/dL | |
| Analytical Specificity | Deviation from control < ±10% | All tested interferents (Haemoglobin, Bilirubin, Triglycerides, Intralipid, Ascorbic Acid, Ethanol, Boric Acid, Gamma Globulin, Glucose, Human Serum Albumin, Sodium Oxalate, Sodium Fluoride, Sodium Chloride) did not interfere at indicated concentrations. |
| Method Comparison (Serum) | Correlation Coefficient r ≥ 0.99 | r = 0.99 |
| Linear Regression: y ≈ x (slope ≈ 1, intercept ≈ 0) | y = 0.99x - 0.10 | |
| Method Comparison (Urine) | Correlation Coefficient r ≥ 0.99 | r = 0.99 |
| Linear Regression: y ≈ x (slope ≈ 1, intercept ≈ 0) | y = 0.98x - 0.24 | |
| Matrix Comparison (Serum vs Plasma) | Correlation Coefficient r ≥ 0.99 | r = 0.99 |
| Linear Regression: y ≈ x (slope ≈ 1, intercept ≈ 0) | y = 0.97x + 0.22 |
Note: Acceptance criteria are often implied by context (e.g., successful demonstration of performance consistent with CLSI guidelines, or by direct comparison with predicate device performance which sets an implicit standard). For precision, specific numerical thresholds are listed based on the demonstrated performance of the predicate device or generally accepted clinical chemistry standards. For linearity and method comparison, r ≥ 0.99 and a linear regression close to y=x are standard and implied criteria for equivalence. For analytical specificity, a deviation of < ±10% is explicitly stated as the sponsor's acceptance criterion.
2. Sample sizes used for the test set and the data provenance:
- Precision (Serum): Not explicitly stated, but "two levels of controls, calibration material and human serum samples for Calcium" were tested across two lots. Each run included two replicates per sample, tested twice per day for 20 non-consecutive days. This implies a significant number of measurements for each level/lot (e.g., 2 samples * 2 replicates * 2 times/day * 20 days = 160 data points per lot/level).
- Precision (Urine): Similar to serum precision, "two levels of urine controls, calibration material and human urine samples for Calcium" were tested across two lots, with two replicates per run, twice per day for 20 non-consecutive days.
- Linearity (Serum): 11 levels of samples were prepared.
- Linearity (Urine): 11 levels of samples were prepared.
- Analytical Specificity (Serum): Not explicitly stated, but interferent levels were tested at Calcium concentrations of 8 mg/dL and 12 mg/dL.
- Analytical Specificity (Urine): Not explicitly stated, but interferent levels were tested at Calcium concentrations of 9 mg/dL and 22.8 mg/dL.
- Method Comparison (Serum): 111 serum patient samples.
- Method Comparison (Urine): 100 urine patient samples.
- Matrix Comparison (Serum vs Plasma): 47 matched patient sample pairs.
Data Provenance: The document does not specify the country of origin for the patient samples. The studies are described as analytical performance studies, meaning they are likely retrospective in the sense that samples were collected and then analyzed for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for such devices is established by reference methods or validated comparative methods, not typically by expert interpretation of images or clinical assessments in the same way as, for example, an imaging AI device. For the method comparison studies, the predicate device (ADVIA Chemistry Calcium_2 (CA_2) Method) serves as the reference for comparison, which itself is a cleared IVD. Therefore, "experts" in the sense of clinicians or radiologists establishing ground truth are not applicable here.
4. Adjudication method for the test set:
Not applicable. The performance is evaluated using quantitative measurements against recognized analytical standards and comparisons with a predicate device, not through adjudication of expert interpretations.
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. This is an in vitro diagnostic device, not an AI-powered diagnostic imaging or decision-support system that involves human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are all standalone performance evaluations of the Randox Calcium (Ca) assay and the RX daytona plus analyzer. This device provides a quantitative measurement and does not involve human-in-the-loop interpretation once the sample is processed by the instrument.
7. The type of ground truth used:
The ground truth or reference standard for this type of device is established through:
- Reference materials/calibrators: used for precision and linearity studies.
- Comparative method (Predicate Device): For method comparison, the results generated by the predicate device (ADVIA Chemistry Calcium_2 (CA_2) Method) on patient samples served as the comparative "truth" or reference.
- Spiked samples: For analytical specificity studies, known concentrations of interferents were added to samples with known calcium concentrations.
8. The sample size for the training set:
Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" of the assay involves the development and optimization of the reagent formulation and instrument parameters, which is a chemical and engineering process, not a data-driven training process in the AI context.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of an AI algorithm. The performance of the chemical assay is established through rigorous analytical validation studies as described above.
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October 23, 2018
Randox Laboratories Ltd. Pauline Armstrong Senior QA/Regulatory Affairs Manager 55 Diamond Road Crumlin, Co. Antrim, BT29 4QY GB
Re: K182042
Trade/Device Name: Randox Calcium (Ca) Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: July 27, 2018 Received: July 30, 2018
Dear Pauline Armstrong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
RANDOX CALCIUM (Ca)
Indications for Use (Describe)
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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RANDOX 510(k) Summary: RANDOX CALCIUM (Ca)
1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
SUBMITTER NAME AND ADDRESS 2.
Name: Dr Pauline Armstrong
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
Date of Summary Preparation: 16 October 2018
3. 510k NUMBER. DEVICE PROPRIETARY NAME. COMMON NAME. PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K182042
RANDOX CALCIUM (Ca) Device Proprietary Name:
Common Name: RANDOX CALCIUM (Ca)
Purpose for Submission: New Device
| ProductCode | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CJY | Calcium testsystem | II | 21 CFR 862.1145 | Clinical Chemistry75 |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
ADVIA Chemistry Calcium_2 (CA_2) Method, 510(k) Number: K083386
5. INTENDED USE
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination of calcium concentration in serum, plasma and urine. This product is suitable for use on the RX series analyzer RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
6. DEVICE DESCRIPTION
The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
CATALOGUE NUMBER: CA8309
R1. Arsenazo III Reagent
4 x 20 ml
REAGENT COMPOSITION
| Contents | Initial Concentration of Solutions |
|---|---|
| RI. Arsenazo III Reagent | |
| Sodium Acetate | 54.2 mmol/l, pH 5.9 |
| Arsenazo | approx.. 230µmol/l |
| Non-Reactive Stabilisers |
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7. PREDICATE DEVICE COMPARISON TABLE
Table 1 Comparison of the Randox Calcium (Ca), with the Advia Chemistry Calcium_2 (CA_2) Method
| CHARACTERISTICS | ADVIAMethod | Chemistry Calcium_2 (CA_2) | Randox Calcium (Ca) |
|---|---|---|---|
| 510(k) K083386 | 510(k) K182042 | ||
| INTENDED USE | A calcium test system intended for thequantitative in vitro determination of calciumconcentration in serum, plasma and urine onthe ADVIA Chemistry systems, | A calcium test system intended for thequantitative in vitro determination ofcalcium concentration in serum, plasmaand urine on the RX series analyser RXdaytona plus. | |
| ASSAY PROTOCOL | Arsenazo III | Arsenazo III | |
| STORAGE(UNOPENED) | Reagents stable to expiry when stored at+15 to +25 ° C | Reagents stable to expiry when stored at+15 to +25 ° C | |
| SAMPLE TYPE | Human serum, plasma & urine | Same | |
| REAGENTCOMPOSITION | Sodium acetate (pH 5.9)54.4 mmol/l | Sodium acetate (pH 5.9)54.4 mmol/l | |
| Arsenazo III188μmol/l | Arsenazoapprox. 230μmol/l | ||
| Non-reactive stabilizers | Non-reactive stabilizers | ||
| FORMAT | Liquid ready to use | Liquid ready to use | |
| MEASURINGRANGE | Serum/Plasma1.0 mg/dL - 16 mg/dL | Serum/Plasma1.0 mg/dL - 16 mg/dL | |
| Urine1.0 mg/dL - 32 mg/dL | Urine1.0 mg/dL - 32 mg/dL | ||
| DEVICECLASSIFICATION | Calcium test system |
The Randox Calcium (Ca) device has the same intended use as the predicate device. Any differences in the technical characteristics between the candidate and predicate device do not affect the safety or effectiveness. Therefore, the Randox Calcium (Ca) device demonstrates substantial equivalence to the predicate device.
8. TEST PRINCIPLE
Arsenazo III specifically binds to Calcium ions to form a coloured complex at 660nm.
pH 5.9 Ca2+ + Arsenazo III --------------------------------------------------------------------------------------------------------------------------------------------------------Ca-Arsenazo III Complex (purple)
The amount of calcium present in the sample is directly proportional to the intensity of the coloured complex formed.
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RANDOX 510(k) Summary: RANDOX CALCIUM (Ca)
9. PERFORMANCE CHARACTERISTICS
Analytical performance:
a. Precision/Reproducibility:
Precision was evaluated consistent with C.L.S.I documents EP05-A3 'Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline -Third Edition.
Precision studies were performed on one RX daytona plus system using two levels of controls, calibration material and human serum samples for Calcium.
Urine precision studies were performed for Calcium using two levels of urine controls, calibration material and human urine samples for Calcium.
Testing was conducted twice per day for 20 non consecutive days. Two replicates per run were performed for each sample.
The results are summarized in the tables below:
Calcium Serum Precision Summary
| Lot 1 | ||||||
|---|---|---|---|---|---|---|
| System: RX daytona plus | Within Run | Total | ||||
| Method | Product | Mean | SD | CV % | SD | CV % |
| (mg/dL) | ||||||
| Ca | Serum Level 1 | 3.89 | 0.12 | 3.1 | 0.16 | 4.1 |
| Ca | Serum Level 2 | 6.61 | 0.16 | 2.4 | 0.24 | 3.6 |
| Ca | Serum Level 3 | 10.78 | 0.28 | 2.6 | 0.40 | 3.7 |
| Ca | Serum Level 4 | 13.95 | 0.32 | 2.3 | 0.52 | 3.7 |
Lot 2
| System: RX daytona plus | Within Run | Total | ||||
|---|---|---|---|---|---|---|
| Method | Product | Mean(mg/dL) | SD | CV% | SD | CV% |
| Ca | Serum Level 1 | 3.85 | 0.08 | 2.1 | 0.16 | 4.2 |
| Ca | Serum Level 2 | 6.65 | 0.16 | 2.4 | 0.28 | 4.2 |
| Ca | Serum Level 3 | 10.70 | 0.24 | 2.2 | 0.44 | 4.1 |
| Ca | Serum Level 4 | 13.83 | 0.32 | 2.3 | 0.56 | 4.0 |
Calcium Urine Precision Summary
Lot 1
| System: RX daytona plus | Within Run | Total | ||||
|---|---|---|---|---|---|---|
| Method | Product | Mean | SD | CV | SD | CV |
| (mg/dL) | % | % | ||||
| Ca | Urine Level 1 | 6.05 | 0.16 | 2.6 | 0.28 | 4.6 |
| Ca | Urine Level 2 | 7.94 | 0.16 | 2.0 | 0.32 | 4.0 |
| Ca | Urine Level 3 | 15.07 | 0.40 | 2.7 | 0.60 | 4.0 |
| Ca | Urine Level 4 | 25.97 | 0.56 | 2.2 | 1.00 | 3.9 |
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510(k) Summary: RANDOX CALCIUM (Ca)
Lot 2
| System: RX daytona plus | Within Run | Total | ||||
|---|---|---|---|---|---|---|
| Method | Product | Mean | SD | CV | SD | CV |
| (mg/dL) | % | % | ||||
| Ca | Urine Level 1 | 6.05 | 0.16 | 2.6 | 0.24 | 4.0 |
| Ca | Urine Level 2 | 7.90 | 0.20 | 2.5 | 0.32 | 4.1 |
| Ca | Urine Level 3 | 15.11 | 0.36 | 2.4 | 0.60 | 4.0 |
| Ca | Urine Level 4 | 26.05 | 0.52 | 2.0 | 0.96 | 3.7 |
b. Linearity/assay reportable range:
Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%).
The linearity samples were prepared at 11 levels including levels below and above the claimed measuring range.
The results are summarized as follows:
Serum Linearity Summary for Calcium
| Lot | Linear Regression | Correlation Coefficient r | Reportable Range |
|---|---|---|---|
| Lot 1 | $y = 1.01x - 0.04$ | 1.00 | 1.0 - 16 mg/dL |
| Lot 2 | $y = 1.02x + 0.04$ | 1.00 | 1.0 - 16 mg/dL |
The reportable range of the assay for serum and plasma samples is 1.0 - 16 mg/dL.
Urine Linearity Summary for Calcium
| Lot | Linear Regression | Correlation Coefficient r | Reportable Range |
|---|---|---|---|
| Lot 1 | y = 0.99x + 0.20 | 1.00 | 1.0 - 32 mg/dL |
| Lot 2 | y = 0.98x + 0.28 | 1.00 | 1.0 - 32 mg/dL |
The reportable range of the assay for urine samples is 1.0 - 32 mg/dL.
c. Analytical Specificity:
The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents. Sponsor's Acceptance Criteria: a deviation of < + 10% for the test sample as compared to the control sample.
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510(k) Summary: RANDOX CALCIUM (Ca)
Serum Summary
The following analytes were tested up to the levels indicated at Calcium concentrations of 8 mg/dL and 12 mg/dL and found not to interfere.
Interferents in serum samples
| Calcium Concentration | ||
|---|---|---|
| Interferent | 8 mg/dL | 12 mg/dL |
| Haemoglobin | 1000 mg/dL | 1000 mg/dL |
| Total Bilirubin | 60 mg/dL | 60 mg/dL |
| Conjugated Bilirubin | 60 mg/dL | 60 mg/dL |
| Triglycerides | 2000 mg/dL | 2000 mg/dL |
| Intralipid | 1315 mg/dL | 2000 mg/dL |
| Ascorbic Acid | 6 mg/dL | 6 mg/dL |
Urine Summary
The following analytes were tested up to the levels indicated at Calcium concentrations of 9 mg/dL and 22.8 mg/dL and found not to interfere.
Interferents in urine samples
| Calcium Concentration | ||
|---|---|---|
| Interferent | 9 mg/dL | 22.8 mg/dL |
| Haemoglobin | 250 mg/dl | 250 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl |
| Conjugated Bilirubin | 60 mg/dl | 60 mg/dl |
| Ascorbic Acid | 200 mg/dl | 200 mg/dl |
| Ethanol | 1000 mg/dl | 1000 mg/dl |
| Boric Acid | 1000 mg/dl | 1000 mg/dl |
| Gamma Globulin | 500 mg/dl | 2000 mg/dl |
| Glucose | 2000 mg/dl | 2000 mg/dl |
| Human Serum Albumin | 500 mg/dl | 500 mg/dl |
| Sodium Oxalate | 100 mg/dl | 100 mg/dl |
| Sodium Fluoride | 1000 mg/dl | 1000 mg/dl |
| Sodium Chloride | 4000 mg/dl | 4000 mg/dl |
d. Method comparison with predicate device:
Correlation studies were carried out in accordance with C.L.S.I. guideline EP09-A2 'Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition."
Serum Correlation
111 serum patient samples spanning the range 1.00 to 15.87 mg/dL (0.25 to 3.96 mmol/l) were tested on the RX davtona plus analyzer with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:
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y = 0.99x - 0.10
Correlation coefficient of r = 0.99
Urine Correlation
100 urine patient samples spanning the range 1.20 to 31.78 mg/dL (0.3 to 7.93 mmol/l), were tested on the RX daytona plus analyzer with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:
y = 0.98 x - 0.24
Correlation coefficient of r = 0.99
e. Matrix comparison (Serum vs Plasma)
Matrix method comparison for the Calcium assay was tested on one RX daytona Plus system and was assessed for two lots of Calcium reagents. Both serum (x) and lithium heparin plasma (y) were tested to determine whether method accuracy with lithium heparin specimens is equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). 47 matched patient sample pairs were analyzed in singlicate spanning the range 1.00 to 14.11 mg/dL and the following linear regression equation was obtained:
y = 0.97 x + 0.22
Correlation coefficient of r = 0.99
10. CONCLUSION
Testing results indicate that the proposed device (RANDOX CALCIUM (Ca)) is safe and effective for the stated intended use and is substantially equivalent to the 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.