MG

K981192 · Abbott Laboratories · JGJ · May 1, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981192
• Device Name: MG
• Applicant: Abbott Laboratories
• Product Code: JGJ · Clinical Chemistry
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

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

Device Story

Magnesium assay is an in vitro diagnostic clinical chemistry test for quantitative determination of magnesium in human serum, plasma, or urine. Device utilizes arsenazo dye that binds preferentially with magnesium; absorbance of resulting arsenazo-magnesium complex is measured at 550 nm. Absorbance is proportional to magnesium concentration in sample. Assay is performed on ALCYON™ Analyzer. Results are used by clinicians to diagnose and treat hypomagnesemia and hypermagnesemia. Benefits include accurate monitoring of magnesium levels to guide clinical management of electrolyte imbalances.

Clinical Evidence

Bench testing only. Method comparison studies on ALCYON™ Analyzer vs. predicate devices. Serum application: r=0.9707, slope=1.067, intercept=0.147 mEq/L. Urine application: r=0.9835, slope=0.933, intercept=0.133 mEq/L. Precision studies (within-run, between-run, between-day) showed total %CV of 3.7-5.9% across levels. Linearity up to 6 mEq/L; limit of quantitation 0.4 mEq/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Arsenazo dye-binding colorimetric method. Measurement: Absorbance at 550 nm. Form factor: Reagent for use on automated clinical chemistry analyzers (ALCYON™).

Indications for Use

Indicated for the quantitative determination of magnesium in human serum, plasma, or urine to aid in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

Regulatory Classification

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).

Predicate Devices

• Roche® Cobas Mira® Plus Automated Chemistry Magnesium assay (K901758)
• Boehringer Mannheim® Magnesium assay (K811194)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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:

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.

#### 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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