MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

K053566 · Diazyme Laboratories · MZV · Feb 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053566
• Device Name: MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
• Applicant: Diazyme Laboratories
• Product Code: MZV · Clinical Chemistry
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in serum. The values obtained by this assay are used to monitor electrolyte balance. Diazyme Potassium Enzymatic Assay has controls for normal serum potassium levels and abnormal serum potassium levels. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

Device Story

In vitro diagnostic enzymatic assay for quantitative potassium measurement in human serum or plasma; utilizes enzymatic reaction principle; modified from previously cleared device (K042191) via changes to assay components and detection wavelength; validated for use on additional clinical chemistry analyzers; intended for use by laboratory professionals in clinical settings to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay for potassium quantification. Modification involves assay components and detection wavelength. Validated for use on clinical chemistry analyzers. Fundamental scientific technology remains consistent with predicate.

Indications for Use

Indicated for the quantitative in vitro determination of potassium in serum to monitor electrolyte balance in patients.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 5 2006

Mr. Huan Tran Quality Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121

k053566 Re:

Trade/Device Name: Diazyme Potassium Enzymatic Assay Regulation Number: 21 CFR§862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: MZV Dated: January 18, 2006 Received: January 19, 2006

Dear Mr. Tran:

We have reviewed your Section 510(k) premarket notification of intent to market the device w Charle roview your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of 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) I ms letter will anow you to oegin maneeting your maneering of your device to a legally prematication. "The PDT Intentig sification 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, If you desire specific information as varies of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v firo Diagnostic Dovieo Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation chilliou, "Miooreneing on your responsibilities under the Act from the Tou may other 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/industry/support/index.html.

Sincerely yours,

Alberto Garcia, Ph.D.

Alberto Gutierrez, Ph.D. 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 (if known): k053566

Device Name: Diazyme Potassium Enzymatic Assay Kit

Indications for Use:

Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low
of Diazyme Potassium Enzymanc Assay Nr. In onjantitive in vitro determination of
and High Calibrators, are intended for the abtained by this assay are used to monitor and High Calibrators, are intended for the quantian Film electrolyte balance.

Diazyme Potassium Enzymatic Assay has controls for normal serum potassium ievel
s for Diazyme Potassium Lifzymatic Assay nuo ontrois are used as reference samples for and abnomal Scrum potabolancieren Potassium Enzymatic Assay.
checking the functionality of the Diazyme Potassium Enzymatic Assay.

Carol Benson

K053566

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)