The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium).

Device Description

Magnesium is an in vitro diagnostic assay for the quantitative determination of magnesium in human serum, plasma, or urine. The Magnesium assay is a clinical chemistry assay which utilizes an arsenazo dye which binds preferentially with magnesium. The absorbance of the arsenazo magnesium complex is measured at 550 nm and is proportional to the concentration of magnesium present in the sample.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for a diagnostic assay, not a device that involves image analysis or human interpretation. Therefore, many of the requested fields related to human readers, experts, ground truth adjudication, and image data provenance are not applicable. I will fill in what is relevant to an in vitro diagnostic (IVD) assay.

Device: Abbott Laboratories Magnesium Assay

This is an in vitro diagnostic assay for the quantitative determination of magnesium in human serum, plasma, or urine, utilizing an arsenazo dye.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this diagnostic assay are based on demonstrating "substantial equivalence" to predicate devices. For IVD assays, this typically means that the new device's performance characteristics (e.g., correlation, precision, linearity, sensitivity) are comparable to or within acceptable limits of the legally marketed predicate device(s). The specific numerical acceptance criteria themselves are not explicitly stated in the summary (e.g., "correlation coefficient must be ≥ 0.95"). Instead, the results are presented and deemed "acceptable" or demonstrating "substantial equivalence."

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation (Serum)	Substantial equivalence to Roche Cobas Mira Plus Magnesium assay (implied acceptable coefficient, slope, and intercept for clinical utility).	Correlation coefficient = 0.9707Slope = 1.067Y-intercept = 0.147 mEq/L
Correlation (Urine)	Substantial equivalence to Boehringer Mannheim Magnesium assay (implied acceptable coefficient, slope, and intercept for clinical utility).	Correlation coefficient = 0.9835Slope = 0.933Y-intercept = 0.133 mEq/L
Precision (Serum)	Substantial equivalence in within-run, between-run, and between-day variability compared to predicate (implied acceptable %CV for clinical utility).	Total %CV Level 1 = 5.9%Total %CV Level 2 = 3.7%
Precision (Urine)	Substantial equivalence in within-run, between-run, and between-day variability compared to predicate (implied acceptable %CV for clinical utility).	Total %CV Level 1 = 5.9%Total %CV Level 2 = 4.4%
Linearity	Demonstrate linearity across the intended measurement range.	Linear up to 6 mEq/L
Limit of Quantitation	Demonstrate adequate sensitivity for clinical utility.	0.4 mEq/L

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

The document does not explicitly state the numerical sample size (number of patient samples) for the "comparative performance studies" (test set). It mentions "two levels of control material" for precision studies.

Sample Size for Test Set: Not explicitly stated (number of patient samples for method comparison). It mentions "two levels of control material" for precision.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective in the sense that they are comparing the new assay's results on samples to those run on established predicate devices, which often involves using existing or collected samples in a laboratory setting. Details on patient demographics or collection methods are not provided.

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

Not applicable. This is an in vitro diagnostic assay that produces a quantitative numerical result. "Ground truth" is established by the performance of the predicate devices or by reference methods, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for method comparison and precision in IVD assays is based on the results from the predicate device and the inherent variability of the assay itself, respectively. There's no human adjudication process involved for this type of test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic assay. Such studies are designed for devices where human interpretation of images or other subjective data is involved. The device produces a quantitative measurement.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the sense that the performance characteristics of the new Magnesium assay (precision, linearity, limit of quantitation) were evaluated independently. However, the primary evidence for substantial equivalence relies on comparative performance with predicate devices for accuracy.

Standalone Performance Evaluated: Precision (within-run, between-run, between-day), linearity, and limit of quantitation (sensitivity).
Results:
- Precision (Serum): Total %CV Level 1 = 5.9%, Level 2 = 3.7%
- Precision (Urine): Total %CV Level 1 = 5.9%, Level 2 = 4.4%
- Linearity: Up to 6 mEq/L
- Limit of Quantitation: 0.4 mEq/L

7. Type of Ground Truth Used

For the method comparison (accuracy) component, the results obtained from the predicate devices were used as the reference ("ground truth") for comparison.

Predicate Devices:
- Roche® Cobas Mira® Plus Automated Chemistry Magnesium assay (K901758) for serum.
- Boehringer Mannheim® Magnesium assay (K811194) on the Hitachi® 717 Analyzer for urine.

For other performance characteristics like precision, the "ground truth" is typically an expected value of the control material or simply the direct measurement of statistical variability.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI. This assay is a chemical measurement method, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no "training set" for this type of in vitro diagnostic assay.

Summary

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K981192

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	March 31, 1998
Device Trade or Proprietary Name:	Mg
Device Common/Usual Name or Classification Name:	Magnesium
Classification Number/Class:	75JGJ /Class I

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

The assigned 510(k) number is:

Test Description:

Substantial Equivalence:

The Magnesium assay is substantially equivalent to the following devices:

. Roche® Cobas Mira® Plus Automated Chemistry Magnesium assay (K901758) for the serum application.
Boehringer Mannheim® Magnesium assay (K811194) on the Hitachi® 717 . Analyzer for the urine application.

Magnesium 510(k) March 30, 1998 MagnesiumE2.lwp

Section II Page 1 0000013

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These assays yield similar Performance Characteristics.

Similarities to Roche:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of magnesium. .
Both assays yield similar clinical results. .

Differences to Roche:

There is a minor difference between the assay ranges. .
Similarities to Boehringer Mannheim:
Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of magnesium. .
Both assays yield similar clinical results. .

Intended Use:

The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Magnesium assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Magnesium assay for the serum application and the Boehringer Mannheim Magnesium assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9707, slope = 1.067 and the Y-intercept = 0.147 mEq/L. For the urine application, the correlation coefficient = 0.9835, slope = 0.933 and the Y-intercept = 0.133 mEq/L. Precision studies were conducted using the Magnesium assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 111 is 5.9% and Level 2/Panel 112 is 3.7%. For the urine application, the total %CV for Level 1/Panel 131 is 5.9% and Level 2/Panel 132 is 4.4%. The Magnesium assay is

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linear up to 6 mEq/L. The limit of quantitation (sensitivity) of the Magnesium assay is 0.4 mEq/L. These data demonstrate that the performance of the Magnesium assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Magnesium assay for the serum application and the Boehringer Mannheim Magnesium assay on the Hitachi 717 Analyzer for the urine application.

Conclusion:

The Magnesium assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Magnesium assay for the serum application and the Boehringer Mannheim Magnesium assay on the Hitatchi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.

Magnesium 510(k) March 30, 1998 MagnesiumE2.lwp

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981192 Magnesium Requlatory Class: I Product Code: JGJ Dated: March 31 1998 Received: April 2, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current-Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 98 | 1 9 2

Magnesium Device Name:

Indications For Use:

The Magnesium assay is used for the quantitation of magnesium in serum, plasma, or urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium).

(Division)
Division
510(k) Number	K981192

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)

00000000

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.