MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7

K063208 · Diagnostic Chemicals , Ltd. · JGJ · Jan 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063208
• Device Name: MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only. The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.

Device Story

The Magnesium Assay (XB) is an in vitro diagnostic reagent system used for the quantitative measurement of magnesium levels in human serum samples. The device includes a reagent and a standard for calibration. It is intended for professional use in clinical laboratory settings. By measuring serum magnesium concentrations, the assay assists healthcare providers in diagnosing and managing conditions related to abnormal magnesium levels, specifically hypomagnesemia and hypermagnesemia. The output provides a quantitative value that informs clinical decision-making regarding patient electrolyte balance and treatment protocols.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Photometric assay using xylidyl blue-1. Single-reagent liquid format. Requires analyzer with 520/660 nm absorbance, 10 nm bandwidth, 0.5% stray light, and 2 nm wavelength accuracy. Traceable to NIST 909b Level 1. Risk management per ISO 14971:2000.

Indications for Use

Indicated for quantitative determination of magnesium in human serum to diagnose and treat hypomagnesemia and hypermagnesemia. Intended for professional in vitro diagnostic 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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Debbie M. Murray Diagnostic Chemicals Ltd. 16 McCarville Street Charlottetown, P.E.I. C1E 2A6 CANADA

JAN 1 9 2007

Re: k063208 Trade/Device Name: Magnesium assay (XB) Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I, reserved Product Code: JGJ, JIT Dated: October 19, 2006 Received: October 24, 2006

Dear Ms. Murray:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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# Indications for Use

510(k) Number:

#### K063208

Device Name:

Magnesium Assay (XB), (125 Series)

Indications For Use:

### Reagent

The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

## Standard

The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH | Office of In Vitro Diagnostic Devices (OIVD) |
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**Division Sign-Off**

**Office of In Vitro Diagnostic**
**Device Evaluation and Safety**

510(k) K063208