DIAZYME CYSTATIN C ASSAY

K093680 · Diazyme Laboratories · NDY · Apr 8, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093680
• Device Name: DIAZYME CYSTATIN C ASSAY
• Applicant: Diazyme Laboratories
• Product Code: NDY · Clinical Chemistry
• Decision Date: Apr 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.

Device Story

Diazyme Cystatin C Assay is an in-vitro diagnostic reagent kit; utilizes latex-enhanced immunoturbidimetric technology to measure Cystatin C levels in human serum or plasma samples. Principle of operation involves antigen-antibody reaction where Cystatin C in sample binds to anti-Cystatin C antibody-coated latex particles, causing turbidity proportional to Cystatin C concentration. Measured via clinical chemistry analyzer; results provide quantitative data to clinicians for assessing renal function and diagnosing/treating renal disease. Used in clinical laboratory settings by trained laboratory personnel. Benefits include objective assessment of kidney function to guide clinical management.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing, including analytical performance studies (precision, linearity, sensitivity, and interference testing) comparing the subject device to the predicate.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay; liquid-stable reagent format. Measures turbidity change at specific wavelengths on automated clinical chemistry analyzers. Designed for in-vitro diagnostic use. No specific materials or software algorithms described beyond standard immunoturbidimetric principles.

Indications for Use

Indicated for the quantitative determination of Cystatin C in human serum or plasma to aid in the diagnosis and treatment of renal disease. For prescription use only.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Diazyme Cystatin C Assay (k072270)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Diazyme Laboratories c/o Dr. Abhijit Datta Director, Technical Operations 12889 Gregg Court Poway, CA 92064

APR 0 8 2010

k093680 Re:

> Trade name: Diazyme Cystatin C Assay Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY Dated: February 05, 2010 Received: February 12, 2010

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, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Directør 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): k093680

Device Name: Diazyme Cystatin C assay

Indication for Use:

The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.

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 (OIVD)

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

510(k) k 093680