K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

K091486 · Kamiya Biomedical Co. · DCF · Apr 29, 2010 · Immunology

Device Facts

• Record ID: K091486
• Device Name: K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
• Applicant: Kamiya Biomedical Co.
• Product Code: DCF · Immunology
• Decision Date: Apr 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

The K-Assay® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction. For in vitro diagnostic use. The K-Assay® Microalbumin Calibrator is for the calibration of the K-Assay® Microalbumin assay for quantifying albumin in urine specimens. For in vitro diagnostic use.

Device Story

K-Assay® Microalbumin is an immunoturbidimetric assay for quantitative determination of human albumin in urine. Device consists of two reagents: R1 (buffer) and R2 (goat anti-human albumin). Input: urine sample; process: antigen-antibody reaction causes agglutination/turbidity; output: turbidity measured at 340 nm and 700 nm. Used in clinical laboratories on automated chemistry analyzers (e.g., Roche Hitachi 917) by laboratory technicians. Output compared to standard calibration curve to determine albumin concentration. Results aid clinicians in diagnosing kidney dysfunction. Includes 6-level calibrators (0.0–30.0 mg/dL) prepared from human albumin.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance characteristics of the immunoturbidimetric assay.

Technological Characteristics

Immunoturbidimetric assay; liquid-stable reagent format; intended for use on automated clinical chemistry analyzers. No specific materials or software algorithms described beyond standard immunoturbidimetric reaction principles.

Indications for Use

Indicated for the quantitative determination of human albumin in urine to aid in the diagnosis of kidney dysfunction. For prescription use.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Kamiya Biomedical Co. c/o Mr. Shawn Kaplan Clinical Diagnostics Product Manager 12779 Gateway Drive Seattle, WA 98168

**APR 29 2010**

Re: k091486

Trade Name: K-Assay® Microalbumin, K-Assay® Microalbumin Calibrator Regulation Number: 21 CFR \$866,5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Codes: DCF, JIT Dated: April 14, 2010 Received: April 20, 2010

Dear Mr. Kaplan:

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,

Signature

Courtney C. Harper, 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 FORM

510(k) Number (if known): K091486

Device Name: Microalbumin Assay

Indications For Use:

The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.

K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.

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

Over-The-Counter Use (21 CFR 801 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) K091486

KAMIYA BIOMEDICAL COMPANY

K-ASSAY® Microalbumin Assay 510(k) Page 4

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