VITALAB MAGNESIUM REAGENT

K040508 · Clinical Data, Inc. · JGJ · Mar 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040508
• Device Name: VITALAB MAGNESIUM REAGENT
• Applicant: Clinical Data, Inc.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Mar 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra E Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Device Story

Vitalab Magnesium Reagent is a single-part chemical reagent used with the Vitalab Selectra Analyzer. It utilizes xylidyl blue chelation to form a colored complex proportional to magnesium concentration in serum or plasma samples. The system is intended for clinical laboratory use to assist in diagnosing and managing magnesium-related disorders. The analyzer performs photometric measurements; results are provided to clinicians to guide patient treatment decisions regarding magnesium levels. The device benefits patients by enabling accurate monitoring of magnesium status.

Clinical Evidence

Bench testing only. Precision demonstrated with 60 replicates per sample (CV 0.7%–3.2%). Linearity confirmed from 0.1 to 5.0 mg/dL. Method comparison (n=118) against predicate showed Deming regression slope of 0.889 and intercept of 0.31 mg/dL. Interference testing performed for bilirubin, hemoglobin, and triglycerides; significant interference noted for triglycerides at ≥1,600 mg/dL.

Technological Characteristics

Single-part liquid reagent; utilizes xylidyl blue chelation chemistry; photometric detection principle; designed for use with Vitalab Selectra Analyzer; standalone reagent kit.

Indications for Use

Indicated for the quantitative determination of magnesium in serum and plasma for the diagnosis and treatment of hypomagnesemia and hypermagnesemia in patients.

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 Magnesium Reagent Kit, product 11489330 (K983416)

Submission Summary (Full Text)

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K040508

Brea, CA 92821 F [phone] T [phone]

> Summary of 510(k) Safety and Effectiveness Information Vitalab Magnesium Reagent

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.

#### Submitted by:

| Clinical Data, Inc.<br>1075 West Lambert Road, Building D<br>Brea, California 92861 | |
|-------------------------------------------------------------------------------------|---------------------------------------------|
| Contact Person: | Wynn Stocking<br>Regulatory Affairs Manager |
| Date Submitted: | February 4, 2004 |

Device Names:

| Proprietary name: | Vitalab Magnesium Reagent |
|----------------------|-------------------------------|
| Common name: | Magnesium reagent |
| Classification Name: | Photometric method, magnesium |

### Device Description:

The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

### Intended Use:

The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

### Predicate Device:

Vitalab Magnesium Reagent Kit is substantially equivalent to the Roche Magnesium Reagent, product no. 11489330, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN

# Summary of Performance Data:

The linear range of the Vitalab Magnesium Reagent is from 0.1 to at least 5.0 mg/dL, as shown by the Usable Range: recovery of linearity related solutions that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.

(Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55

510(k) Notification, Vitalab Magnesium Reagent Kit - Additional Information Clinical Data, Brea, California

February 4, 2004 Page 49

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- Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and started on organisand was steplation and start the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two standad the results are oour overy values, is rounded up to 0.1 mg/dL, which is the round off error of the test.
- Precision is demonstrated by the replicate assay of commercially available control serum. Precision Precision: statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 60 | 1.2 | 0.03 | 2.2% | 0.4 | 3.2% |
| Serum 2 | 60 | 2.2 | 0.02 | 0.8% | 0.3 | 1.1% |
| Serum 3 | 60 | 3.3 | 0.02 | 0.7% | 0.3 | 1.0% |

Fifty eight serum specimens ranging from 1.5 to 5.2 mg/dL magnesium and 60 heparinized plasma Correlation: specimens ranging from 1.5 to 2.8 mg/dL magnesium were collected from adult patients and were assayed for magnesium using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

> Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent syx = 0.04 mg/dL range = 1.5 - 5.2 mg/dL n = 118

- The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.1 mg/dL.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 8 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: k040508

> Trade/Device Name: Vitalab Magnesium Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: February 27, 2004 Received: February 27, 2004

Dear Mr. Devine:

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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## Page 2

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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Image /page/4/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "K040508". The characters are written in a bold, sans-serif font, and they appear to be handwritten. A horizontal line is present beneath the sequence of characters.

Device Name:

Vitalab Magnesium Reagent

Indications for Use:

The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).

prescription

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040508