The Atellica™ CH Magnesium (Mg) assay is for in vitro diagnostic use in the quantitative determination of magnesium in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

Device Description

The Atellica CH Mg assay is based on the modified xylidyl blue reaction, which was first described by C.K. Mann and J.H. Yoe. 1-2 The reagent was modified to eliminate the use of organic solvents. Magnesium ions react with xylidyl blue in an alkaline medium to form a water-soluble purple-red complex. The increase in absorbance of xylidyl blue at 505/694 nm is proportional to the concentration of magnesium in the sample. Calcium is excluded from the reaction by complexing with EGTA.

AI/ML Overview

This document describes the performance assessment of the Siemens Atellica CH Magnesium (Mg) assay, an in vitro diagnostic device used for the quantitative determination of magnesium in human serum, plasma, and urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study and compared to the predicate device. The document does not explicitly list "acceptance criteria" as a separate column with pass/fail remarks, but rather presents the study results, implying that these results met the internal validation requirements for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implicit, based on predicate/industry standards)	Reported Device Performance (Atellica CH Magnesium (Mg))
Detection Limit	LoB meets protocol, LoD for serum/urine meets protocol	LoB: 0.00 mg/dL, LoD: 0.02 mg/dL (serum), 0.04 mg/dL (urine)
Limit of Quantitation (LoQ)	Lowest sample concentration meets max allowable imprecision (5% CV) and bias (15%)	Serum LoQ: 0.46 mg/dL (supports 0.50 mg/dL measuring interval) Urine LoQ: 0.57 mg/dL (supports 1.00 mg/dL measuring interval)
Linearity	p-values of nonlinear terms <= 0.05, OR allowable bias <= 5% or 0.10 mg/dL	Demonstrated linear across 0.50 to 5.00 mg/dL (serum/plasma) and 1.00 to 14.00 mg/dL (urine)
Precision	Consistent and acceptable within-lab precision and repeatability %CV or SD	(See detailed table in original document for various samples and concentrations) Example: Serum (0.78 mg/dL): Repeatability CV 3.0%, Within-Lab CV 3.9%
Interferences	Bias exceeding 10% not detected at specified interferent concentrations	No interference detected at specified concentrations (e.g., Hemoglobin 500 mg/dL, Bilirubin 30 mg/dL in serum)
Method Comparison (vs. Predicate)	Good agreement (high correlation, acceptable regression equation)	Serum: N=108, r=0.996, y=0.94x + 0.09 mg/dL Urine: N=100, r=0.998, y=0.96x - 0.06 mg/dL Lithium heparin plasma: N=109, r=0.998, y=0.97x + 0.09 mg/dL
Matrix Equivalency	Good agreement between serum and plasma samples	Demonstrated by similar method comparison results for lithium heparin plasma.
Expected Values (Reference Intervals)	Verified in accordance with CLSI Document EP28-A3c	Serum/plasma: 1.60 to 2.60 mg/dL Urine: 24 to 255 mg/24 hour
Extended Measuring Interval	Support for 2x upper measuring intervals	Serum/plasma: up to 10 mg/dL Urine: up to 28 mg/dL
Standardization/Traceability	Traceable to Atomic Absorption reference method, within ± 5.0% of target for NIST SRM 909	Traceable to Atomic Absorption method, recovered within ± 5.0% of expected value for NIST SRM 909.

2. Sample Sizes Used for the Test Set and Data Provenance

Detection Limit (LoB/LoD):
- LoB: 4 samples with no analyte tested (N=5) for 3 days, 1 run/day, 3 reagent lots (Total of 60 measurements for LoB calculation).
- LoD: 4 low analyte samples tested (N=5) for 3 days, 1 run/day, 3 reagent lots (Total of 60 measurements for LoD calculation).
Limit of Quantitation (LoQ): 4 low samples processed on 3 reagent lots for 3 days, on 1 instrument, for a total of 60 measurements per lot for both serum/plasma and urine.
Linearity Study:
- Serum: 10 samples (prepared by mixing high and low concentration samples). 4 replicates measured for each sample.
- Urine: 10 samples (prepared by mixing high and low concentration samples). 4 replicates measured for each sample.
Precision Studies: N = 2 replicates, two times a day for at least 20 days for a total of 80 replicates with controls, serum, and plasma pools on one instrument.
Interferences: Not explicitly stated as a number of samples, but samples were "fresh sample pools containing either low or high levels of measurand in serum and urine pools." Dilution studies were conducted "as needed for both serum pools."
Method Comparison:
- Serum: 108 remnant de-identified samples.
- Urine: 100 remnant de-identified samples.
- Lithium heparin plasma (for Matrix Equivalency): 109 samples.
Data Provenance: The studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel. The samples for method comparison were "remnant de-identified samples," implying a retrospective collection from a clinical laboratory setting. The country of origin of the data is not specified, but Siemens Healthcare Diagnostics Inc. is based in the US (Newark, DE, and Tarrytown, NY), suggesting data from the US or a region with similar clinical practices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is an in vitro diagnostic (IVD) assay for quantitative measurement of magnesium. The "ground truth" for such devices is typically established through a reference method or known concentrations of certified reference materials, not through expert consensus or clinical experts like radiologists.
The document states that "Magnesium values are traceable to Atomic Absorption reference method which is calibrated with NIST SRM 929 reference material." This indicates that the ground truth is based on an established, highly accurate analytical method and certified reference materials.
Qualifications of Experts: The personnel conducting the study were "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting." They were trained on the operation of both the device and the predicate device. This implies expertise in laboratory procedures and instrument operation, rather than clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative chemical assay, ground truth is established analytically (reference method, certified materials), not through human adjudication of qualitative findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic device for a quantitative chemical measurement, not an AI-assisted diagnostic imaging or classification system that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a standalone automated chemical analyzer. Its performance, as described, is the standalone performance of the instrument and reagents in determining magnesium concentrations. There is no human-in-the-loop component in the analytical measurement process itself; human involvement is in operating the instrument and interpreting the results.

7. The Type of Ground Truth Used

Analytical Ground Truth:
- Reference Method: Traceable to "Atomic Absorption reference method."
- Certified Reference Materials: Calibrated with "NIST SRM 929 reference material."
- Clinical Samples: For method comparison studies, "remnant de-identified samples" were used, where the predicate device's measurement served as a comparative reference. For linearity, samples were prepared by "mixing high and low concentration samples" or "spiking native serum or urine pools with magnesium acetate."

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning. This is a traditional IVD chemical assay, not an AI/ML algorithm that requires a "training set" for model development. The development and optimization of the assay (e.g., reagent formulation, reaction conditions) would be based on laboratory R&D, but not in the same way an AI model is trained on a data set.

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/ML algorithm. The "ground truth" during the development of the assay would be established through standard analytical chemistry principles, using known concentrations and reference methods to ensure the assay accurately measures magnesium.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA DUGGAN REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, PO BOX 6101 MS 514 NEWARK DE 19711

Re: K162399

Trade/Device Name: Atellica Ch Magnesium (Mg) Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium Test System Regulatory Class: I, reserved Product Code: JGJ Dated: December 14, 2016 Received: December 15, 2016

Dear Dr. Duggan:

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

January 19, 2017

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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/Resourcesfor You/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.

Katherine Serrano -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) K162399

Device Name Atellica CH Magnesium (Mg)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY 10.

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

ASSIGNED 510(K) NUMBER

The assigned 510(k) number is K162399.

APPLICANT AND DATE

Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens.com Phone: 302-631-7654 Fax: 302-631-6299

January 19, 2017

MANUFACTURER

Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235

REGULATORY INFORMATION

Regulatory Submission for the Atellica™ CH Magnesium (Mg)

Common Name:	Photometric Method, Magnesium
Proprietary Name:	Atellica CH Magnesium (Mg)
Classification Name:	Magnesium Test System
Regulation Number:	21CFR862.1495
Classification:	Class I
Product Code:	JGJ
Panel:	Clinical Chemistry
Predicate Device:	Dimension Magnesium FlexReagent Cartridge (K861700)

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DEVICE DESCRIPTION

ATELLICA CH MAGNESIUM (MG)

Reaction Equation

Xylidyl Blue + Mg2+

OH-

Xylidyl Blue (Mg2+) Complex

Serum, lithium heparin plasma and urine specimens may be used. The reagent is stored unopened at 2 - 8 °C and is stable for use on system for 14 days. Calibration is performed every 60 days for a reagent lot or every 3 days for an individual pack.

INTENDED USE/INDICATIONS FOR USE

ATELLICA CH MAGNESIUM (MG)

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Below is a features comparison for the Atellica CH Magnesium (Mg) assay and the predicate device:

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Feature	Predicate Device:Dimension Magnesium FlexReagent Cartridge (K861700)	New Device:Atellica CH Magnesium (Mg)
Intended Use :	The MG method used on theDimension® clinicalchemistry system is an invitro diagnostic test intendedfor the quantitativedetermination of magnesiumin human serum,heparinized plasma andurine.	The Atellica™ CHMagnesium (Mg) assay is forin vitro diagnostic use in thequantitative determination ofmagnesium in human serum,plasma (lithium heparin), andurine using the Atellica™ CHAnalyzer.
Indications for Use:		Magnesium measurementsare used in the diagnosis andtreatment ofhypomagnesemia(abnormally low levels ofmagnesium) andhypermagnesemia(abnormally high levels ofmagnesium).
Device Technology:	Methylthymol blue (MTB)complexometric procedure	Xylidyl blue reaction
Sample Type:	Serum, plasma and urine	Serum, Lithium Heparinplasma, and urine
Expected Values:	Serum/Plasma1.8 - 2.4 mg/dLUrine24 – 255 mg/24hr	Serum/plasma1.60 to 2.60 mg/dLUrine :Same
Standardization:	NIST SRM 929	Same

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CalibrationFrequency:	90 days	60 days
Analytical MeasuringInterval:	Serum/Plasma:0.0 - 20.0 mg/dLUrine:0.0 - 20.0 mg/dL	Serum and plasma:0.50 to 5.00 mg/dLUrine: 1.00 to 14.00 mg/dL
Interferences:	Bilirubin (Unconjugated) -40 mg/dLLipemia (Intralipid®) - 1000mg/dLHemoglobin – 200 mg/dL	Bilirubin (Unconjugated) - 30mg/dLBilirubin (Conjugated) - 30mg/dLLipemia (Intralipid®) - 500mg/dLHemoglobin - 500 mg/dL

SUMMARY OF PERFORMANCE TESTING

Assay performance comparison results for the Atellica CH Magnesium (Mg) were obtained by processing the appropriate body fluids. Summary statistics for each are provided. These data demonstrate substantial equivalency of the Atellica CH Magnesium (Mg) compared to the predicate device. The following data represent typical assay performance.

DETECTION LIMIT

The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline.

Assessment of LoB was the 95th percentile of all values (sorted from lowest to highest), using non-parametric approach.

LoB Rank Position = 0.5 +0.95*B, where B=total reps=60; Rank = 57.5

Atellica CH Magnesium (Mg) - Detection Capability
Limit	Protocol	Result

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LoB	4 samples with no analytewere tested (N=5) for 3days, one run per day, 3reagent lots	0.00 mg/dL
LoD	4 low analyte sampleswere tested (N=5) for 3days, one run per day, 3reagent lots	0.02 mg/dL serum0.04 mg/dL urine

LOQ

The Limit of Quantitation (LoQ) for serum was determined as described in CLSI Document EP17-A2. The mean, SD, %CV and bias relative to the reference values were calculated for each sample per reagent lot. The lowest sample concentration that met the maximum allowable imprecision and maximum allowable bias acceptance criteria was taken as the LoQ estimate for each reagent lot.

For both serum/plasma and urine fluids, 4 low samples were processed on three reagent lots for three days, on one instrument for a total of 60 measurements per lot. For serum LoQ estimate is 0.46 mg/dL (0.19 mmol/L) with maximum allowable imprecision of 5% CV and maximum allowable bias of 15%. For Urine LoQ estimates is 0.57 mg/dL (0.23 mmol/L) with maximum allowable imprecision of 5% CV and maximum allowable bias of 15%. For serum, the measured LoQ was 0.46 mg/dL in support of the low end of the measuring interval of 0.50 mg/dL for serum and plasma samples. For urine, the measured LoQ was 0.57 mg/dL in support of the low end of the measuring interval of 1.00 mg/dL for urine samples.

LINEARITY STUDY

Linearity was evaluated with 10 samples which spanned the assay measuring interval for serum specimens and 10 samples which spanned the assay measuring interval for urine specimens. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A). The high sample was prepared by spiking native serum or urine pools with magnesium acetate. Low pools were created by diluting serum and urine samples with saline solution. Four replicates were measured for each sample. The mean of these replicates was used for the calculations.

The assay was considered linear across the measuring interval if the p values of nonlinear terms in the quadratic and cubic fit equations are nonsignificant (p ≤ 0.05). If

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the p-value is > 0.05, then the allowable bias is ≤ 5% or 0.10 mg/dL, whichever is greater. Linearity of the Atellica CH Magnesium (Mg) was demonstrated with both serum and urine specimens to encompass the measuring intervals of 0.50 to 5.00 mg/dL for serum and plasma specimens and 1.00 to 14.00 mg/dL for urine specimens.

PRECISION STUDIES

Precision testing was performed in accordance with CLSI EP05-A3 Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline -Third Edition. Precision was tested n = 2 replicates, two times a day for at least 20 days for a total of 80 replicates with controls, serum and plasma pools on one instrument. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP05-A3. The data are summarized in the following table.

			Repeatability		Within-Lab Precision
Sample Type	n	Meanmg/dL (mmol/L)	SDamg/dL (mmol/L)	CVb(%)	SDamg/dL (mmol/L)	CVb(%)
Serum	80	0.78 (0.32)	0.023 (0.009)	3.0	0.031 (0.013)	3.9
Plasma	80	1.51 (0.62)	0.034 (0.014)	2.3	0.051 (0.021)	3.4
Serum QC	80	2.53 (1.04)	0.044 (0.018)	1.7	0.050 (0.021)	2.0
Serum	80	4.22 (1.74)	0.024 (0.010)	0.6	0.047 (0.019)	1.1
Urine QC1	80	4.61 (1.89)	0.037 (0.015)	0.8	0.097 (0.040)	2.1
Urine QC2	80	11.19 (4.60)	0.108 (0.044)	1.0	0.141 (0.058)	1.3

ª SD = standard deviation

b CV = coefficient of variation

INTERFERENCES

CLSI EP7-A2 was followed for the interference testing. The interference study was conducted using a "paired difference worst case scenario" approach where these compounds were spiked into fresh sample pools containing either low or high levels of measurand in serum and urine pools.

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Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference. Dilution studies were conducted to determine the level at which the spiked substance no longer displayed significant interference. Dilution studies were conducted at two analyte concentrations, if both sample pools show significant interference. This study was conducted as needed for both serum pools.

Approximate Concentration (within 15%) of Analytes in Test Pools
Analyte	Matrix	Low	High
Magnesium	Serum	1.60 mg/dL	2.60 mg/dL
Magnesium	Urine	2.00 mg/dL	6.00 mg/dL

No interference was detected at the following analyte concentrations.

Interference Testing for Serum

Substance	Substance Test ConcentrationCommon Unit
Hemoglobin	500 mg/dL
Bilirubin, conjugated	30 mg/dL
Bilirubin,unconjugated	30 mg/dL
Lipemia (Intralipid®)	500 mg/dL
EDTA	12.5 mg/dL
Copper	0.50 mg/dL
Calcium	20 mg/dL
Iron	0.50 mg/dL
Zinc	0.25 mg/dL
Acetaminophen	200 mg/dL
Ibuprofen	500 mg/dL

Interference Testing for Urine

Substance	Substance Test ConcentrationCommon Unit
6N HCl	0.01% HCl
Ascorbate	50 mg/dL
Hemoglobin	150 mg/dL
Calcium	20 mg/dL
Conjugated Bilirubin	30 mg/dL
Copper	0.50 mg/dL
Iron	0.50 mg/dL
Zinc	0.25 mg/dL

METHOD COMPARISON

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The predicate device selected for the method comparison study was the Dimension Magnesium Flex Reagent Cartridge. Remnant de-identified samples were tested. No patient history information was obtained on these samples. Inclusion/exclusion data criteria are not applicable. The study included native and diluted samples to properly span the assay intervals.

These studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel. The personnel conducting the study were laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting. They were trained on the operation of both the device and the predicate device. A split sample method comparison, following EP09-A3, demonstrated good agreement between the Atellica CH Magnesium (Mg) and the predicate Dimension Magnesium Flex Reagent Cartridge (Mg) assay with patient samples.

The results across the full assay intervals were analyzed using Deming regression. One replicate of each sample was tested and used in the analysis.

SpecimenType	ComparisonAssay (x)	N	r	RegressionEquation	Sample Range (onthe Dimension RxL)
Serum	Dimension RxLMg	108	0.996	$y = 0.94x + 0.09$mg/dL (0.04mmol/L)	0.48-5.16 mg/dL(0.20 - 2.12mmol/L)
Urine	Dimension RxLMg	100	0.998	$y = 0.96x - 0.06$mg/dL (0.02mmol/L)	1.10-13.22 mg/dL(0.45 - 5.43mmol/L)

MATRIX EQUIVALENCY

Due to the difficulty with obtaining matched serum and plasma magnesium samples across the measuring interval, an additional method comparison study was conducted with lithium heparin plasma samples on Atellica CH Magnesium (Mg) and Dimension Magnesium Flex Reagent Cartridge. Some samples were diluted to obtain samples spanning the assay measuring interval. The table below summarizes the Deming linear regression statistics. One replicate of each sample was tested and used in the analysis.

SpecimenType	ComparisonAssay (x)	N	r	RegressionEquation	Sample Range (onthe DimensionRxL)
Lithiumheparinplasma	Dimension RxLMg	109	0.998	y = 0.97x + 0.09mg/dL (0.04mmol/L)	0.50-5.05 mg/dL(0.21 - 2.08mmol/L)

EXPECTED VALUES

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Reference intervals for healthy adults were verified on the Atellica CH Analyzer in accordance with CLSI Document EP28-A3c. As with all in vitro diagnostic assays, each laboratory should determine its own reference interval for the diagnostic evaluation of patient results. Consider these values as guidance only.

Group	Specimen type	Reference Intervalcommon unit (SI unit)
Adults	Serum/plasma1	1.60 to 2.60 mg/dL (0.66 to 1.07 mmol/L)
Adults	Urine2	24 to 255 mg/24 hour (0.99 to 10.45mmol/24 hour)

Wu AHB. Tietz Clinical Guide to Laboratory Tests. 4™ ed. Philadelphia, PA: WB Saunders Co: 2006:706.

Pesce, A.J. and Kaplan, L.A., Methods in Clinical Chemistry, C.V. Mosby Co., St. Louis, 1987. 1.

EXTENDED MEASURING INTERVAL

The Mq assay parameters support both serum/plasma and urine extended ranges 2x the upper measuring intervals. Two-fold manual dilutions of 5 serum pools and 5 urine pools were made with CH Diluent, and both the undiluted and diluted pools were processed with N=5 replicates. The serum/plasma extended measuring interval is up to 10 mg/dL. The urine extended measuring interval up to 28 mg/dL.

STANDARDIZATION

Magnesium values are traceable to Atomic Absorption reference method which is calibrated with NIST SRM 929 reference material. SRM909 reference material from the National Institute of Standards and Technology (NIST) was processed with N=5 replicates with 3 reagent lots of Atellica CH Maqnesium (Mg) and the mean results were compared to the target value. All results recover within ± 5.0% of the expected value.

CONCLUSION

The Atellica CH Magnesium (Mg) is substantially equivalent to the Dimension Magnesium Flex Reagent Cartridge in principle and performance based on the similarity of device designs and function demonstrated through method comparison and other performance attributes.

Regulation Number and Section

§ 862.1495 Magnesium test system.

(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. 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).(b)
Classification. Class I.