ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353

K983416 · Boehringer Mannheim Corp. · JGJ · Oct 21, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983416
• Device Name: ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
• Applicant: Boehringer Mannheim Corp.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.

Device Story

Roche Diagnostics Magnesium Reagent is an in vitro diagnostic reagent system for automated clinical chemistry analyzers. It utilizes a colorimetric photometric method; magnesium reacts with xylidyl blue in an alkaline solution in the presence of EGTA to form a purple complex. EGTA complexes with calcium to ensure specificity for magnesium. The intensity of the purple complex is proportional to magnesium concentration and is measured spectrophotometrically. The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing magnesium-related metabolic disorders (hypomagnesemia and hypermagnesemia).

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and performance characteristics comparing the new reagent system to the predicate.

Technological Characteristics

Photometric magnesium test system. Reagents: R1 and R2 liquid, ready-to-use. Principle: Xylidyl blue dye binding in alkaline solution with EGTA. Measurement: Spectrophotometric. Calibration: Two-point (saline blank and 1.4 mmol/L standard). Stability: 3-week on-board reagent stability.

Indications for Use

Indicated for the quantitative determination of magnesium in human serum, plasma, and 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 Diagnostics Magnesium reagent system (K810084)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation, dba Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br><br>Contact Person: Luann Ochs<br><br>Date Prepared: September 18, 1998 |
| 2) Device name | Proprietary name: Roche Diagnostics Magnesium Reagent<br><br>Common name: magnesium test system<br><br>Classification name: photometric method, magnesium 75JGJ<br>Device Class I |
| 3) Predicate<br>device | We claim substantial equivalence to the currently marketed Roche<br>Diagnostics Magnesium reagent system, catalog number 804551,<br>manufactured by Bio-Analytical labs. K810084. |
| 4) Device<br>Description | Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an<br>alkaline solution.<br><br>Magnesium + xylidyl blue <span style="text-decoration:underline;">alkaline</span> -> purple complex<br><br>EGTA in the reagent complexes with calcium, so that only magnesium reacts<br>with the indicator. The intensity of the color of the purple complex formed is<br>proportional to the magnesium concentration and can be measured<br>photometrically. |

{1}------------------------------------------------

## 510(k) Summary, Continued

| 5) Intended use | The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison to predicate device | The Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084. |

The following table illustrates the similarities between the Roche Diagnostics Magnesium Reagent and the predicate device. Specific data on the

Magnesium Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI.

| Feature | New Magnesium<br>Reagent | Predicate Magnesium<br>Reagent |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of<br>magnesium | Measurement of<br>magnesium |
| Sample Type | Serum, plasma, CSF,<br>no preparation required.<br>Urine, diluted with<br>0.9% saline or water | Serum, plasma, CSF,<br>no preparation required.<br>Urine, acidified to pH 1<br>prior to assay |
| Use on Automated<br>Chemistry Analyzers? | Yes | Yes |
| Test Principle | Magnesium is reacted<br>with xylidyl blue in an<br>alkaline solution, in the<br>presence of EGTA,<br>resulting color is<br>measured spectro-<br>photometrically | Magnesium is reacted<br>with calmagite in an<br>alkaline solution, in the<br>presence of EGTA and<br>KCN, resulting color is<br>measured spectro-<br>photometrically |
| Calibration | Two points, blank<br>(saline) and about 1.4<br>mmol/L (2.8<br>mEq/L)magnesium | Two points, blank<br>(saline) and about about<br>1.4 mmol/L (2.8<br>mEq/L)magnesium |

## Similarities:

Continued on next page

{2}------------------------------------------------

## 510(k) Summary, Continued

6) Comparison to predicate device (continued)

| Feature | New Magnesium<br>Reagent | Predicate Magnesium<br>Reagent |
|-------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Calibration Stability | Perform a new<br>calibration with a bottle<br>or reagent lot change | Perform a new<br>calibration every 24<br>hours, and with a bottle<br>or reagent lot change |
| Kit Configuration,<br>Reagent Preparation | R1, liquid, ready-to-use<br>R2, liquid, ready-to-use | R1, liquid, ready-to-use<br>R2, liquid, ready-to-use |
| Reagent On-board<br>Stability | 3 weeks | 1 week |

#### Similarities:

#### 6) Comparison Differences: to predicate

device,

continued

There are no significant differences between the Roche Diagnostics Magnesium reagent and the predicate device for purposes of considering substantial equivalence.

### Performance characteristics:

The performance of the Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notabiy it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 21 1998

Luann Ochs . Requlatory Program Manager Boehringer Mannheim Corporation, dba Roche Diagnostics 9115 Haque Road P.O. Box 50457 46250-0457 Indianapolis, Indiana

Re: K983416 Roche Diagnostics Magnesium Reagent Requlatory Class: I Product Code: JGJ Dated: September 18, 1998 Received: September 29, 1998

Dear Ms. Ochs:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਬ 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 regulation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

{4}------------------------------------------------

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 Gutman.

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 ..

{5}------------------------------------------------

K983416 510(k) Number (if known): Device Name: Roche Diagnostics Magnesium Reagent

Indications for Use:

The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1495, 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). It is classified in Class I.

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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 983916