DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B

K082763 · Diazyme Laboratories · MZU · Nov 12, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082763
• Device Name: DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
• Applicant: Diazyme Laboratories
• Product Code: MZU · Clinical Chemistry
• Decision Date: Nov 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Device Story

Modification to previously cleared device (K042189); transition of reagent state from freeze-dried powder to liquid; adjustment of reagent component concentrations; fundamental scientific technology remains unchanged; design control activities performed to assess impact of modifications; verification and validation activities confirmed predetermined acceptance criteria met.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical of enzymatic sodium assays.

Technological Characteristics

Reagent-based diagnostic device; modification involves transition from lyophilized (freeze-dried) powder to liquid state and adjustment of component concentrations.

Indications for Use

Indicated for quantitative in vitro determination of sodium in serum for patients suspected of electrolyte imbalance, including conditions such as aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and inappropriate antidiuretic hormone secretion.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 12 2008

Diazyme Laboratories c/o Abhijit Datta, Ph.D. Director, Manufacturing & Quality Control 12889 Gregg Court Poway, CA 92064

Re: k082763

Trade Name: Diazyme Liquid Stable Enzymatic Sodium Assay Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Codes: MZU Dated: October 24, 2008 Received: October 28, 2008

Dear Dr. Datta:

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, Dr u 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, isting 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 (1 win 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 Begister.

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 Prt 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.

Yéan 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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## Indication for Use

510(k) Number (if known): k082763

Device Name: Diazyme Liquid Stable Enzymatic Sodium Assay

Indication For Use:

Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082763