K Number

Device Name

MAGNESIUM ASSAY

Manufacturer

SEKISUI DIAGNOSTICS P.E.I. INC.

Date Cleared

2011-12-02

(149 days)

Product Code

JGJ

Regulation Number

862.1495

Intended Use

The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

Device Description

The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K944407

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay for measuring magnesium levels using chemical reagents and automated chemistry analyzers. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies described are standard analytical validation methods for IVD assays.

Therapeutic

No.
The Sekisui Magnesium Assay is an in vitro diagnostic device used for the quantitative determination of magnesium levels in human serum and plasma for diagnostic purposes, not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia... and hypermagnesemia." It also states "This device is intended for... IN VITRO diagnostic use only."

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic assay kit consisting of chemical reagents, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This device is intended for professional use and IN VITRO diagnostic use only."
Purpose: The device is designed for the "quantitative determination of magnesium in human serum and plasma," which is a biological sample analyzed in vitro (outside the body).
Clinical Application: The results are used in the "diagnosis and treatment of hypomagnesemia and hypermagnesemia," indicating a clinical diagnostic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the IN VITRO quantitative measurement of magnesium in serum and plasma.
The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

Product codes (comma separated list FDA assigned to the subject device)

JGJ

Device Description

The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTA, and a surfactant.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use and IN VITRO diagnostic use only.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision/Reproducibility: Precision testing was performed according to CLSI guideline EP5-A2. Samples, including serum pools and control materials, were tested twice per day in duplicate for 20 days. Results are summarized in the provided table.
Linearity/assay reportable range: A linearity study was performed in accordance with CLSI protocol EP6-A. The method was demonstrated to be linear across the reportable range from 0.2 mg/dL (0.08 mmol/L) to 8.0 mg/dL (3.29 mmol/L). A high concentration serum pool was diluted with saline to produce 11 concentrations of magnesium. Samples were assayed in replicates of four. The linearity testing confirmed a reportable range of 0.3 - 8.0 mg/dL (0.12 - 3.29 mmol/L).
Detection limit: Determination of method detection limits was performed according to CLSI EP17-A Guideline. LoD was determined by measuring 60 replicates of a zero magnesium sample and 60 replicates of the low concentration serum control sample. The LoB was 0.15 mg/dL, LoD was 0.25 mg/L, and LoQ was 0.30 mg/L.
Analytical specificity: Interference studies on the effects of endogenous and exogenous substances were designed according to CLSI EP7-A2 guideline. Potentially interfering substances evaluated included unconjugated bilirubin, conjugated bilirubin, hemoglobin, lipemia, and ascorbic acid. Three samples of human serum with different concentrations of magnesium were tested with potential interference substances and analyzed in quadruplicate. No significant interference was defined as being within +/- 10% of the corresponding control result for the high magnesium sample.
Method comparison with predicate device: A method comparison study was performed based on the CLSI EP9-A2 guideline. Serum samples (n=100) were obtained and determined to be within the reportable range of both the candidate and predicate methods (0.5 mg/dL to 7.3 mg/dL magnesium). The Sekisui Diagnostics Magnesium Assay on the Roche Hitachi 717 automated analyzer was compared to the Beckman Coulter method on the AU640. Regression statistics: Slope: 0.981, Intercept: 0.00 mg/dL, Correlation: 0.9848.
Matrix comparison: A matrix comparison study was conducted using fresh samples from non-fasting donors drawn as serum and Li Heparin plasma. Comparison was made between the Sekisui Diagnostics Magnesium method with serum and with plasma on the Roche Hitachi 717 automated analyzer. Regression statistics: Slope: 1.009, Intercept: - 0.12 mg/dL, Correlation: 0.9903.
Expected values/Reference range: Testing followed the CSLI C28-A guideline to validate the reference range using a study of 20 serum samples from apparently healthy donors. The testing did not result in outliers, supporting literature reports of adult reference ranges for magnesium.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision:
- Total CV %: 6.1 (at 0.8 mg/dL), 3.7 (at 2.0 mg/dL), 3.2 (at 4.7 mg/dL)
- Within Run CV %: 7.0 (at 0.9 mg/dL), 2.2 (at 2.0 mg/dL), 1.6 (at 4.9 mg/dL)
Linearity: Slope 1.01, Intercept 0.013 mg/dL, N 11
Detection Limits: Limit of Blank (LoB) = 0.15 mg/dL, Limit of Detection (LoD) = 0.25 mg/L, Limit of Quantitation (LoQ) = 0.30 mg/L
Method Comparison: Samples, n= 100, Slope: 0.981, Intercept: 0.00 mg/dL, Correlation: 0.9848
Matrix Comparison: Samples, n= (unspecified, symbol looks like "દ્વ"), Slope: 1.009, Intercept: - 0.12 mg/dL, Correlation: 0.9903

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.

K944407

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Kll915

DEC - 2 2011

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY

DEVICE ONLY TEMPLATE

A. 510(k) Number:

K111915

B. Purpose for Submission:

New Device

C. Measurand:
Magnesium

D. Type of Test:

Quantitative, Photometric Method

E. Applicant:
Sekisui Diagnostics P.E.I. Inc.

F. Proprietary and Established Names:

Magnesium Assay

G. Regulatory Information:

1. Requlation section:
  21 CFR 862.1495
1. Classification:
  Class I
1. Product code:
  JGJ

Panel:

Chemistry (75)

H. Intended Use:

1. Intended use(s):
  For the IN VITRO quantitative measurement of magnesium in serum and plasma.
1. Indication(s) for use:
  The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.
1. Special conditions for use statement(s):
  For prescription use only

4. Special instrument requirements:

Clinical chemistry analyzers (testing was performed on the Roche/Hitachi® 717 Automated Analvzer).

I. Device Description:

The Sekisui Magnesium assay kit consists of the following:

Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.

J. Substantial Equivalence Information:

1. Predicate device name(s):
  Beckman Coulter Magnesium Reagent

Predicate 510(k) number(s):

K944407

3. Comparison with predicate:

(Similarities and Differences between the candidate device and the predicate device).

Parameter	Candidate Device	Predicate Device
	Sekisui Diagnostics
Magnesium Assay	Beckman Coulter
Magnesium Reagent OSR6189
		K944407
Analyte	Magnesium	Magnesium
Intended Use	For the IN VITRO quantitative
measurement of magnesium in
serum and plasma.	System reagent for the quantitative
determination of Magnesium in
Human serum, plasma and urine on
Beckman Coulter AU analyzers.
Sample Matrix	Serum or LiHeparin Plasma	Serum or Heparinized Plasma or
urine
Reportable Range	0.3 - 8.0 mg/dL	0.5 -8.0 mg/dL
Reference Interval	1.6-2.6 mg/dL	1.9-2.7 mg/dL
Technology /
Methodology	Colorimetric endpoint method
using xylidyl blue.	Colorimetric endpoint method using
xylidyl blue.
Format	Liquid	Liquid

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A2, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline

CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline

CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient samples; Approved Guideline

CLSI EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline

CLSI C28-A2, How to define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline

L. Test Principle:

Xylidyl blue-1 + Mg** -> Mg-xylidyl blue complex (red)

Under the alkaline conditions of the Magnesium reagent, magnesium present in the sample, when mixed with reagent, forms a red complex with the diazonium salt of xylidyl blue. The concentration of magnesium in the sample is directly proportional to the amount of xylidyl blue -Magnesium complex formed and can be measured spectrophotometrically by the decrease in absorbance measured at 660 nm.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

Precision testing was performed according to CLSI guideline EP5-A2. Samples, including serum pools and control materials, were tested twice per day in duplicate for 20 days. Results are summarized below:

Precision table for Sekisui Diagnostics Magnesium on Roche Hitachi 717 automated analyzer:

| Concentration | | Total SD | | Total
CV % | Concentration | | Within Run SD | | Within
Run
CV % |
|---------------|-------|----------|--------|---------------|---------------|--------|---------------|--------|-----------------------|
| mg/dL | mmol/ | mg/dL | mmol/L | | mg/d | mmol/L | mg/d | mmol/L | |
| 0.8 | 0.33 | 0.05 | 0.021 | 6.1 | 0.9 | 0.37 | 0.06 | 0.024 | 7.0 |
| 2.0 | 0.82 | 0.07 | 0.029 | 3.7 | 2.0 | 0.82 | 0.04 | 0.016 | 2.2 |
| 4.7 | 1.93 | 0.15 | 0.062 | 3.2 | 4.9 | 2.01 | 0.08 | 0.033 | 1.6 |

b. Linearity/assay reportable range:

A linearity study was performed in accordance with CLSI protocol EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures, a Statistical Approach, and the Sekisui Diagnostics Magnesium method was demonstrated to be linear across the reportable range from 0.2 mg/dL (0.08 mmol/L) to 8.0 mg/dL (3.29 mmo//L). A high concentration serum pool was diluted with saline to produce 11 concentrations of magnesium. Samples were assayed in replicates of four. The results were used to generate best fit regression lines using a linear equation.

Nonlinearity is less than allowable nonlinearity.

Summary of Linear Fit

Slope 1.01

Intercept 0.013 mg/dL

N 11

The linearity testing confirmed a reportable range of 0.3 - 8.0 mg/dL (0.12 - 3.29 mmol/L).

c. Detection limit:
The determination of the method detection limits was performed according to the CLSI EP17-A Guideline, Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. Limit of Detection (LoD) is defined as the smallest amount of an analyte that the method can reliably detect to determine presence or absence of the analyte. LoD was

determined by measuring 60 replicates of a zero magnesium sample and 60 replicates of the low concentration serum control sample.

The results were used following the EP17-A quidelines to calculate the Limit of Blank (LoB). Limit of Detection, and Limit of Quantitaion (LoQ). The Limit of Blank was determined as 0.15 mg/dL magnesium. The Pooled SD for the low values of the samples was determined as 0.06 mg/dL; therefore, the LoD is calculated to be 0.25 mg/L. The LoQ represents the magnesium concentration where the CV is less than or equal to 20%. The LoQ is therefore 0.30 mg/L.

d. Analytical specificity:
Interference studies on the effects of endogenous and exogenous substances were designed according to the CLSI EP7-A2 guideline. Potentially cross-reactive or interfering substances that were evaluated included five endogenous substances (unconjugated bilirubin, conjugated bilirubin, hemoglobin, lipemia, and ascorbic acid). Three samples of human serum with different concentrations of magnesium were tested with the potential interference substances and analyzed in quadruplicate on the Roche Hitachi 717 automated analyzer. No significant interference was defined to be within +/- 10% of the corresponding control result for the high magnesium sample.

| Concentration of
Analyte | | Substance Tested Interference is Insignificant | |-----------------------------|--------| | mg/dL | mmol/L | | 2.1 | 0.86 | | 4.2 | 1.73 | 7.9 | 3.25 | | 2.0 | 0.82 | | 4.3 | 1.77 | 6.8 | 2.79 | | 2.0 | 0.82 | | 4.2 | 1.73 Bilirubin | 40 mg/dL | 6.8 | 2.79 | | 2.3 | 0.95 | | 4.4 | 1.81 | 6.8 | 2.79 | | 1.9 | 0.78 | mmol/L) Simulated
Triglycerides |
| 4.1 | 1.69 mg/dL mmol/L) Simulated
Triglycerides |
| 6.9 | 2.84 | mg/dL mmol/L) Simulated
Triglycerides | | Concentration of Interferent where
|
---------------------------|---------------------------------------------------------------------|--------------------------------------------------------|
| | |
| 1000 mg/dL | 155 µmol/L |
| Hemoglobin | 1000 mg/dL | 155 µmol/L |
| 1000 mg/dL | 155 µmol/L |
| 40 mg/dL | 684 µmol/L |
| Conjugated Bilirubin | 40 mg/dL | 684 µmol/L |
| 40 mg/dL | 684 µmol/L |
| 40 mg/dL | 684 µmol/L |
| Unconjugated
| 684 µmol/L |
| 40 mg/dL | 684 µmol/L |
| 3000 µg/dL | 170 µmol/L |
| Ascorbic Acid | 3000 µg/dL | 170 µmol/L |
| 3000 µg/dL | 170 µmol/L |
| 800 mg/dL | 2400 mg/dL (27.1
| Intralipid | 1000
| 3000 mg/dL (33.9
| 1000
| 3000 mg/dL (33.9

e. Assay cut-off:

Not applicable

1. Comparison studies:
- a. Method comparison with predicate device:

A method comparison study was performed based on the CLSI EP9-A2 guideline. Serum samples (n=100) were obtained for the study, of which 100 were determined to be within the reportable range of the candidate method and the Predicate method (sample recoveries ranged from 0.5 mg/dL to 7.3 mg/dL magnesium. The Beckman Coulter method on the AU640 was used to compare the results performed using the Sekisui Diagnostics Magnesium Assay on the Roche Hitachi 717 automated analyzer. The results demonstrate the Sekisui Diagnostics Magnesium test method on Roche Hitachi 717 is substantially comparable with the Beckman Coulter magnesium assay on AU640 analyzer. A summary of the regression statistics is provided below:

Samples, n= 100

Slope: 0.981 Intercept: 0.00 mg/dL Correlation: 0.9848

b. Matrix comparison:

A matrix comparison study was conducted using fresh samples from non-fasting donors drawn as serum, and Li Heparin plasma. Sekisui Diagnostics Magnesium method with serum was used to compare the results obtained using the Sekisui Diagnostics Magnesium Assay with plasma on the Roche Hitachi 717 automated analyzer. The results demonstrate the Sekisui Diagnostics Magnesium test method with plasma is substantially comparable with the Sekisui Diagnostics Magnesium test method with serum on Roche Hitachi 717 analyzer. A summary of the regression statistics is provided below:

Samples, n= દ્વ

Slope: 1.009

Intercept: - 0.12 mg/dL

Correlation: 0.9903

1. Clinical studies:
  a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
1. Clinical cut-off:
  Not applicable
1. Expected values/Reference range:
  Testing followed the CSLI C28-A guideline to validate the reference range using a study of 20 serum samples from apparently healthy donors. The reference range is validated if the samples result in no outliers. The testing did not result in outliers supporting the literature reports of adult reference ranges for magnesium. [Tietz, N.W., (Editor) Clinical Guide to Laboratory Tests, W.B. Saunders Company, Philadelphia (1983) p.338.].

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The information presented in the premarket notification demonstrates that the performance of the Sekisui Diagnostics Magnesium Reagent for use with human serum and lithium heparin plasma is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using patient samples with magnesium values that span the assay range.

The information presented in the premarket notification provides a reasonable assurance that the Sekisui Diagnostics Magnesium for use with human serum and lithium heparin plasma is safe and effective for the stated intended use.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human profile, with outstretched wings.

10903 New Hampshire Avenue Silver Spring, MD 20993

SEKISUI DIAGNOSTICS P.E.I. INC C/O Penny White 70 Watts Ave Charlottetown Prince Edward Island Canada C1E2B9

DEC - 2 2011

Re: K111915

Trade Name: MAGNESIUM ASSAY Regulation Number: 21 CFR §862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I,reserved Product Codes: JGJ Dated: October 19, 2011 Received: October 24, 2011

Dear Ms. White

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ Magnesium Assay

Indications for Use:

The Sekisui Magnesium Assay is intended for the quantitative measurement of magnesium in human serum and plasma (Lithium Heparin) on automated clinical chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. This device is intended for professional use and IN VITRO diagnostic use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)