(441 days)
No
The device description and performance studies focus on a chemical reaction and photometric measurement, with no mention of AI/ML algorithms for analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic test designed to measure magnesium levels in human samples, which aids in diagnosis. It does not provide any treatment or therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the method is "an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine" and that "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia... and hypermagnesemia." This directly indicates its role in diagnosis.
No
The device is described as an in vitro diagnostic test using reagent cartridges and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System."
Similarly, the description of the CHEM 1 CAL states: "The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen... Magnesium... methods on the Dimension Vista® System."
These statements clearly indicate that both the reagent cartridge and the calibrator are intended for use in diagnostic procedures performed outside of the body (in vitro), which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
JIX, JGJ
Device Description
CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.
The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
A split sample method comparison study, following EP09-A2, demonstrated good agreement between the Dimension Vista® MG Flex® reagent cartridge versus the Beckman AU Magnesium assay (K981743).
A combined total of 239 serum and plasma samples were tested on the Dimension Vista® MG Flex® reagent cartridge and the Beckman AU Magnesium assay. In an additional study, 99 urine samples were tested using the Dimension Vista® MG Flex® reagent cartridge versus the Beckman AU Magnesium assay. All samples were run in duplicate however; only the first result was used for analysis.
Key Results:
Serum (n=114): Range: 0.6-7.7 mg/dL, Slope: 1.10, Intercept: -0.15 mg/dL, Correlation Coefficient: 1.00
Lithium heparin plasma (n=125): Range: 0.8-7.5 mg/dL, Slope: 1.05, Intercept: -0.01 mg/dL, Correlation Coefficient: 0.994
Urine (n=99): Range: 1.5 - 9.3 mg/dL, Slope: 1.05, Intercept: 0.09 mg/dL, Correlation Coefficient: 0.995
Precision:
Precision testing was performed in accordance with CLSI EP05-A2. Samples consisted of two serum pools, three levels of Multiqual QC material, one level of Liquichek Urine QC material and one urine pool.
Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data.
Key Results:
Multiqual® Unassayed Control Level 1 (Mean 1.1 [0.45]): Repeatability SD 0.1 [0.04] (%CV 4.8), Within-Lab SD 0.1 [0.04] (%CV 5.1)
Multiqual® Unassayed Control Level 2 (Mean 2.5 [1.03]): Repeatability SD 0.1 [0.04] (%CV 2.9), Within-Lab SD 0.1 [0.04] (%CV 2.9)
Multiqual® Unassayed Control Level 3 (Mean 4.0 [1.60]): Repeatability SD 0.1 [0.04] (%CV 1.9), Within-Lab SD 0.1 [0.04] (%CV 2.4)
Serum Pool 1 (Mean 1.9 [0.78]): Repeatability SD 0.1 [0.04] (%CV 3.4), Within-Lab SD 0.1 [0.04] (%CV 3.7)
Serum Pool 2 (Mean 4.5 [1.85]): Repeatability SD 0.1 [0.04] (%CV 1.8), Within-Lab SD 0.1 [0.04] (%CV 2.1)
Liquichek™ Urine Chemistry Control Level 1 (Mean 7.0 [2.88]): Repeatability SD 0.1 [0.04] (%CV 1.2), Within-Lab SD 0.1 [0.04] (%CV 1.5)
Urine Pool 1 (Mean 7.3 [3.00]): Repeatability SD 0.1 [0.04] (%CV 1.0), Within-Lab SD 0.1 [0.04] (%CV 1.3)
Limit of Blank and Limit of Detection:
Determined consistent with CLSI guideline EP17-A2.
Key Results:
Serum: LoB = 0.002 mg/dL, LoD = 0.1 mg/dL.
Urine: LoB = 0.2 mg/dL, LoD = 0.3 mg/dL.
Limit of Quantitation:
Testing involved running six serum samples and six urine samples with magnesium levels at the trial LoQ concentration of approximately 0.3 mg/dL. Five replicates (n=5) of each sample were run with two different reagent lots, on three days.
Key Results:
The calculated Total Error (TE) for all serum samples met the goal of TE ≤ 0.2 mg/dL, supporting an MG LoQ claim of 0.3 mg/dL.
The calculated TE for all urine samples met the goal of TE ≤ 0.2 mg/dL, supporting an MG LoQ claim of 0.3 mg/dL.
The LoQ for the MG assay is 0.3 mg/dL.
Linearity:
Evaluated using a series of manually prepared dilutions of serum and urine samples that spanned the assay range, as described in CLSI EP06-A.
Key Results:
Serum (n=9): Range: 0.4 – 11.4 mg/dL, Slope: 1.0109, Intercept: -0.0089, Correlation Coefficient: 0.9998
Urine (n=9): Range: 0.3 – 11.4 mg/dL, Slope: 0.9997, Intercept: 0.0583, Correlation Coefficient: 0.9986
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2015
SIEMENS HEALTHCARE DIAGNOSTICS HELEN LEE REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE M/S 514 NEWARK DE 19714
Re: K140790
Trade/Device Name: Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) Dimension Vista® Magnesium Flex® Reagent Cartridge (MG) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: II Product Code: JIX, JGJ Dated: May 4, 2015 Received: May 5, 2015
Dear Ms. Helen Lee:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
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) K140790
Device Name
Dimension Vista® Magnesium Flex® reagent cartridge (MG) Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL)
Indications for Use (Describe)
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
| 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) |
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5.0 510 (k) Summary
5.1 Description
Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) / Class II Dimension Vista® Magnesium Flex® reagent cartridge (MG) /Class I
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
5.2 Assigned 510(k) number
The assigned 510(k) number is: K140790
5.3 Applicant and Date
| Applicant: | Helen M. Lee
Siemens Healthcare Diagnostics
500 GBC Drive
Mailstop 514
Newark, DE 19714-6101 |
| ------------ | ---------------------------------------------------------------------------------------------------------- |
|---|
Date: June 11, 2015
5.4 Proprietary and Established Names
Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) Dimension Vista® Magnesium Flex® reagent cartridge (MG)
4
5.5 Regulatory Information
Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL)
| Classification Name: | Calibrator, Multi-Analyte |
|---|---|
| Regulation Section: | 862.1150 - Calibrator |
| Classification; | Class II |
| Product Code: | JIX |
| Panel: | Clinical Chemistry |
Dimension Vista® Magnesium Flex®reagent cartridge (MG)
| Classification Name: | Photometric method, Magnesium, secondary |
|---|---|
| Regulation Section: | 862.1495 - Magnesium test system |
| Classification: | Class 1 |
| Product Code: | JGJ |
| Panel: | Clinical Chemistry |
5.6 Predicate Devices
Dimension® Chemistry 1 Calibrator (CHEM 1 CAL) - K061838 Dimension® Magnesium Flex® reagent cartridge (MG) - K061655
5.7 Device Description(s)/Test Principle:
CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.
The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.
5.8 Device Intended Use:
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN) Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
The MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
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5.9 Indications for Use
The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN) Calcium (CA). Cholesterol (CHOL). Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
5.10 Substantial Equivalence Information:
The proposed Siemens Healthcare Diagnostics Dimension Vista® CHEM 1 CAL (KC110B) and the predicate Dimension Vista® CHEM 1 CAL (K061838) are the exact same products with the same formulation. They are both in vitro diagnostics products for the calibration of Blood Urea Nitrogen, Calcium, Cholesterol, Creatinine, Glucose, Lactic Acid, Magnesium, Thyroxine, Thyronine Uptake and Uric Acid methods on the Dimension Vista® System. The modification described in this 510(k) submission is a change to use System Water instead of Dimension Vista® CHEM 1 CAL Level 1(CAL A), when calibrating the Dimension Vista® Magnesium method.
A comparison summary of the features of both products is included in the following page.
A comparison of the similarities and differences between the Dimensium Flex "reagent cartridge (MG) (proposed device) and the Dimension® Magnesium Flex reagent cartridge (MG) - K061655 is also included in the following tables.
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Similarities between the Proposed and Predicate Magnesium Devices
| Feature | Proposed Device | Predicate Device |
|---|---|---|
| Dimension Vista® Magnesium | ||
| Flex® reagent cartridge (MG) | Dimension® Magnesium Flex® | |
| reagent cartridge (MG) | ||
| Intended Use | The MG method is an in | |
| vitro diagnostic test for the | ||
| quantitative measurement of | ||
| magnesium in human serum, | ||
| plasma and urine on the | ||
| Dimension Vista® System. | ||
| Magnesium measurements are | ||
| used in the diagnosis and | ||
| treatment of hypomagnesemia | ||
| (abnormally low plasma levels of | ||
| magnesium) and | ||
| hypermagnesemia (abnormally | ||
| high plasma levels of | ||
| magnesium). | The MG method used | |
| on the Dimension® clinical | ||
| chemistry system is an in | ||
| vitro diagnostic | ||
| test intended for the | ||
| quantitative determination of | ||
| magnesium in human serum, | ||
| heparinized plasma and urine. |
Differences Between the Proposed and Predicate Magnesium Devices
| Feature | Proposed Device | Predicate Device |
|---|---|---|
| Dimension Vista® Magnesium | ||
| Flex® reagent cartridge (MG) | Dimension® Magnesium Flex® | |
| reagent cartridge (MG) | ||
| Methodology | Methylthymol blue | |
| (MTB) | Methylthymol blue | |
| (MTB) | ||
| Calibration Interval | 90 days | 90 days |
| Limit of Blank/Analytical | ||
| Sensitivity | 0.2 mg/dL (LoB) | 0.0 mg/dL (Analytical |
| Sensitivity) | ||
| Measuring Range - | ||
| Serum/Plasma | 0.3-10.0 mg/dL | 0.0-20.0 mg/dL |
| Measuring Range - | ||
| Urine | 0.3-10.0 mg/dL | 0.0-20.0 mg/dL |
| Detection Conditions | Bichromatic | |
| 600 and 510 nm | Bichromatic | |
| 600 and 510 nm | ||
| Expected Values - | ||
| Serum/Plasma | 1.6-2.6 mg/dL | 1.8-2.4 mg/dL |
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Similarities between the Proposed and Predicate Calibrators
| Feature | Proposed Device
Dimension Vista®
CHEM 1 CAL | Predicate Device
Dimension Vista® CHEM 1 CAL
(KC110B) |
|-----------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Same | The CHEM 1 CAL is an in vitro diagnostic product for the
calibration of Calcium (CA), Cholesterol (CHOL), Creatinine
(CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG),
Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen
(BUN) and Uric Acid (URCA) methods on the Dimension
Vista® System. |
| Traceability | Same | MG - NIST SRM 929 |
| Form | Same | Frozen Liquid |
Differences between the Proposed and the Predicate Calibrators
| Feature | Proposed Device
Dimension Vista® CHEM 1 CAL | Predicate Device
Dimension Vista® CHEM 1 CAL |
|-------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------|
| Catalog # /REF | KC110B | KC110B |
| Typical
Calibration Levels
for the MG
Method | Level 1: 0.0 mg/dL [0.00 mmol/L]
will be used for Level 1 ( not
Calibrator A) | Level 1 (Calibrator A): 0.3 mg/dL [0.12 mmol/L] |
| | Level 2 (Calibrator B): same as the
predicate | Level 2 (Calibrator B): 21.1 mg/dL [8.68 mmol/L] |
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5.11 Standards/Guidance Document References
- Stability Testing of In Vitro Diagnostic Reagents (CEN 13640)
- . Interference Testing of Clinical Chemistry; Approved Guideline (EP07-A2)
- . Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2)
- Evaluation of the Linearity of Quantitative Measurement; Approved Guideline (EP06-A) .
- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures . (EP17-A2)
- . Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline (EP05-A2)
- . Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory: Approved Guideline Third Edition (EP28-A3c)
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Performance Characteristics 5.12
The following data represent typical method performance. Data were collected on the Dimension Vista® 1500 System.
5.12.1 Method Comparison
Testing was conducted internally by Siemens Healthcare Diagnostics R&D personnel. The technicians conducting the studies had training similar to personnel who would perform testing in a hospital laboratory setting. Technicians were trained on the operation of both the proposed device and the predicate device. A split sample method comparison study, following EP09-A2, demonstrated good agreement between the Dimension Vista® MG Flex® reagent cartridge versus the Beckman AU Magnesium assay (K981743).
A combined total of 239 serum and plasma samples were tested on the Dimension Vista® MG Flex® reagent cartridge and the Beckman AU Magnesium assay. In an additional study, 99 urine samples were tested using the Dimension Vista® MG Flex® reagent cartridge versus the Beckman AU Magnesium assay. All samples were run in duplicate however; only the first result was used for analysis.
| Comparative
Method | Sample
Type | Range
(mg/dL) | Slope | Intercept
(mg/dL) | Correlation
Coefficient | N |
|--------------------------------------------------|------------------------------|------------------|-------|----------------------|----------------------------|-----|
| Vista MG
method vs
Beckman AU
MG method | Serum | 0.6-7.7 | 1.10 | -0.15 | 1.00 | 114 |
| | Lithium
heparin
plasma | 0.8-7.5 | 1.05 | -0.01 | 0.994 | 125 |
| | Urine | 1.5 - 9.3 | 1.05 | 0.09 | 0.995 | 99 |
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5.12.2 Precision
Precision testing was performed in accordance with CLSI EP05-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline- Second Edition.
Samples consisted of two serum pools, three levels of Multiqual QC material, one level of Liquichek Urine QC material and one urine pool.
Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP05-A2. The following table is a summary of the data.
| | Mean
(mg/dL)
[mmol/ dL] | Standard Deviation (%CV) | |
|------------------------------------|-------------------------------|--------------------------|------------------|
| | | Repeatability | Within-Lab |
| Multiqual® Unassayed Control | | | |
| Level 1 | 1.1 [0.45] | 0.1 [0.04] (4.8) | 0.1 [0.04] (5.1) |
| Level 2 | 2.5 [1.03] | 0.1 [0.04] (2.9) | 0.1 [0.04] (2.9) |
| Level 3 | 4.0 [1.60] | 0.1 [0.04] (1.9) | 0.1 [0.04] (2.4) |
| Serum Pool 1 | 1.9 [0.78] | 0.1 [0.04] (3.4) | 0.1 [0.04] (3.7) |
| Serum Pool 2 | 4.5 [1.85] | 0.1 [0.04] (1.8) | 0.1 [0.04] (2.1) |
| Liquichek™ Urine Chemistry Control | | | |
| Level 1 | 7.0 [2.88] | 0.1 [0.04] (1.2) | 0.1 [0.04] (1.5) |
| Urine Pool 1 | 7.3 [3.00] | 0.1 [0.04] (1.0) | 0.1 [0.04] (1.3) |
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5.12.3 Limit of Blank and Limit of Detection
Serum:
The Limit of Detection (LoD) for MG, using serum samples, is 0.2 mg/dL [0.08 mmol/L], determined consistent with CLSI guideline EP17-A2 and with proportions of false positives (a) less than 5% and false negatives (ß) less than 5%; based on 96 determinations, with 4 blank and 4 low level samples.
| Dimension Vista® Magnesium Limit of Detection with Serum | ||
|---|---|---|
| Test | Protocol | Value |
| LoB | Four samples with no analyte were tested (n=5) for | |
| three days, one run/day, using two reagent lots | 0.002 mg/dL | |
| LoD | Four low serum samples were tested (n=5) for | |
| three days one run/day, using two reagent lots | 0.1 mg/dL |
The nonparametric approach described in CLSI EP17-A2 was followed to determine the Limit of Detection.
LoB=Mean of Blank Measurement + 1.645 X Standard Deviation of Blank Measurements LoD=Limit of Blank + CpSDs
Cp is a correction factor for the 95% CI normal variate to account for bias in the SDs estimate
SDs is an estimate of imprecision pooled from replicates of the low level samples
The LoB was determined to be 0.002 mg/dL in serum samples with no analyte and is consistent with the claim of 0.2 mg/dL.
The LoD was determined to be 0.1 mg/dL in serum samples and is consistent with the claim of 0.3 mg/dL.
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Urine:
The Limit of Detection (LoD) for MG, using urine samples, is 0.3 mg/dL, determined consistent with CLSI guideline EP17-A2 and with proportions of false positives (d) less than 5% and false negatives (β) less than 5%; based on 96 determinations, with 4 blank and 4 low level samples.
| Dimension Vista® Magnesium Limit of Detection with Urine | |||
|---|---|---|---|
| Test | Protocol | Value | |
| LoB | Five diluted urine samples were tested (n=5) for | ||
| three days, one run/day, using two reagent lots | 0.2 mg/dL | ||
| LoD | Five low concentration urine samples were tested | ||
| (n=5) for three days one run/day, using two reagent | |||
| lots | 0.3 mg/dL |
The nonparametric approach described in CLSI EP17-A2 was followed to determine the Limit of Detection.
LoB=Mean of Blank Measurement + 1.645 X Standard Deviation of Blank Measurements
LoD=Limit of Blank + CpSDs
Cp is a correction factor for the 95% CI normal variate to account for bias in the SDs estimate
SDs is an estimate of imprecision pooled from replicates of the low level samples
The LoB was determined to be 0.2 mg/dL in urine samples with no analyte and is consistent with the claim of 0.2 mq/dL.
The LoD was determined to be 0.3 mg/dL in urine samples and is consistent with the claim of 0.3 mg/dL.
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5.12.4 Limit of Quantitation
Testing involved running six serum samples and six urine samples with magnesium levels at the trial LoQ concentration of approximately 0.3 mg/dL. Five replicates (n=5) of each sample were run with two different reagent lots, on three days, to produce a total of 90 replicates for each lot. A LoQ concentration was calculated for each lot, and the larger LoQ from the 2 lots was taken as the final LoQ result.
TE = Total Error = |Bias| + 2 x sd
The calculated TE for all serum samples, for each reagent lot tested, met the goal of TE ≤ 0.2 mg/dL, therefore, the serum LoQ criterion was deemed to be met. The lowest serum sample concentration that met the goal for both reagent lots: 13361BA and 14196AA, was 0.2 mg/dL. The results support the MG LoQ claim of 0.3 mg/dL.
TE = Total Error = |Bias| + 2 x sd
The calculated TE for all urine samples, for each reagent lot tested, met the goal of TE ≤ 0.2 mg/dL, therefore, the urine LoQ criterion was deemed to be met. The lowest urine sample concentration that met the goal for both reagent lots: 14196AA and 14303BA was 0.3 mg/dL. The results support the MG LoQ claim of 0.3 mg/dL.
The LoQ for the MG assay is 0.3 mg/dL, determined consistent with the guidelines in CLSI document EP17-A2, based on 180 determinations; and a Total Error goal of 0.2 mg/dL calculated using the Westgard model.
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5.12.5 Linearity
Linearity was evaluated using a series of manually prepared dilutions of serum and urine samples that spanned the assay range. The individual samples were prepared by blending samples with high and low magnesium concentrations across the measurement range as described in CLSI Evaluation of the Linearity of Quantitative Measurement Procedures (EP06-A).
Regression Statistics
| Sample | Range | Units | Slope | Intercept | Corr Coef | n |
|---|---|---|---|---|---|---|
| Serum | 0.4 – 11.4 | mg/dL | 1.0109 | -0.0089 | 0.9998 | 9 |
| Urine | 0.3 – 11.4 | mg/dL | 0.9997 | 0.0583 | 0.9986 | 9 |
5.13 Conclusion
The Dimension Vista® Chemistry 1 Calibrator (KC110B) is substantially equivalent in design, formulation, packaging and intended use to the Dimension Vista® Chemistry 1 Calibrator previously cleared under K061838.
The modification described in this 510(k) submission is a change to use System Water instead of Dimension Vista® CHEM 1 CAL Level 1 (CAL A) when calibrating the Dimension Vista® Magnesium method. The Dimension Vista® Magnesium Flex® reagent cartridge (MG, K3057), with the truncated assay range, is substantially equivalent to the Beckman magnesium assay cleared under K981743