ATAC PAK MAGNESIUM REAGENT

K030010 · Elan Diagnostics · JGJ · Mar 10, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030010
• Device Name: ATAC PAK MAGNESIUM REAGENT
• Applicant: Elan Diagnostics
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Mar 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Device Story

ATAC PAK Magnesium Reagent Kit is an in vitro diagnostic reagent for use on the ATAC 8000 Random Access Chemistry System. It utilizes xylidyl blue to selectively bind magnesium in serum or plasma samples, forming a red-purple chelate. The system measures the resulting increase in absorbance at 510 nm, which is proportional to the magnesium concentration. Operated by trained laboratory personnel in professional clinical settings, the system provides quantitative magnesium results to assist clinicians in diagnosing and managing magnesium-related metabolic disorders (hypomagnesemia and hypermagnesemia).

Clinical Evidence

Bench testing only. Linearity established from 0.1 to 5.5 mEq/L. Precision studies (n=60 per sample) showed within-run CVs of 4.1%–8.8% and total CVs of 5.4%–12.0%. Method comparison against a competitive reagent (n=110) yielded a Deming regression of y = 0.964x + 0.04. Detection limit is 0.1 mEq/L. Onboard reagent stability (8 hours) and calibration stability (4 hours) were verified.

Technological Characteristics

Colorimetric assay using xylidyl blue reagent. Principle: selective binding to magnesium forming a red-purple chelate measured at 510 nm. Designed for use on the ATAC 8000 Random Access Chemistry System. Reagent stability: 8 hours onboard; calibration stability: 4 hours.

Indications for Use

Indicated for the quantitative determination of magnesium in serum and plasma for the diagnosis and treatment of hypomagnesemia and hypermagnesemia in adult patients. For professional use only; not for home use.

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

• Beckman Synchron Magnesium Reagent (product 445360)

Submission Summary (Full Text)

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MAR 1 0 2003

Image /page/0/Picture/2 description: The image shows the word "élan" in a stylized font. The "é" has a unique design, with a small, textured, diamond-like shape above it. The rest of the letters are in a flowing, cursive style. The entire word is in black and set against a white background.

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1075 W. Lambert Road Building D Brea, California 92821 T [phone] F [phone]

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

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 ATAC PAK Magnesium Reagent Kit is intended for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.

The ATAC PAK Magnesium Reagent Kit is substantially equivalent to the Beckman Synchron Magnesium Reagent, product 445360, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC PAK Magnesium Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of magnesium using the ATAC PAK Magnesium Reagent is linear from 0.1 to 5.5 mEq/L, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.

$$\text{ATAC Rewveries} = 0.0 \text{ mEq/dL} + 0.983 \times \text{(Standard Value)}, \quad \text{r} = 0.996, \quad s_{\text{Y.x}} = 0.15 \text{ mEq/L}, \quad n = 36$$

Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

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| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|-------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 60 | 1.0 | 0.09 | 8.8% | 0.12 | 12.0% |
| Serum 2 | 60 | 1.9 | 0.10 | 5.2% | 0.13 | 7.1% |
| Serum 3 | 60 | 2.8 | 0.12 | 4.1% | 0.15 | 5.4% |

Mixed serum and plasma specimens, collected from adult patients, were assayed for magnesium using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

ATAC 8000 = 0.04 mEq/L + 0.964 x Competitive Reagent range = 1.2 - 5.4 mEq/L $s_{v.x}$ = 0.10 mEq/L n = 110

The detection limit of 0.1 mEg/L is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.02 mEq/L. Consequently, the detection limit is reported as 0.1 mEq/L, which is the round-off error of the assay.

The 8 hour onboard reagent stability and 4 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. The average changes in recovery are less than 0.25 mEqL over the 8 hour onboard claim and less than 0.05 mEq/L over the 4 hour calibration stability claim.

Wynn Stocking

Manager of Regulatory Affairs Elan, Brea California

510(k) Notification, ATAC PAK Magnesium Reagent Kit, 31 December, 2002, p 47

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 0 2003

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821

Re: k030010

Trade/Device Name: ATAC PAK Magnesium Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: December 31, 2002 Received: January 2, 2003

Dear Mr. Stocking:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K030010

510(k) Number (if known):

Device Name:

ATAC PAK Magnesium Reagent

Indications for Use:

The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper

Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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