HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER

K080384 · The Binding Site, Ltd. · NDY · Jun 6, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080384
• Device Name: HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
• Applicant: The Binding Site, Ltd.
• Product Code: NDY · Clinical Chemistry
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.

Device Story

In vitro diagnostic kit for quantitative measurement of Cystatin C in human serum and plasma samples; utilizes turbidimetric assay principle on Roche Modular P analyzer; intended for clinical laboratory use by trained personnel; results aid clinicians in diagnosing and monitoring renal disease; provides objective biomarker data to supplement clinical assessment and other laboratory findings.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on analytical performance characteristics for the intended use.

Technological Characteristics

Turbidimetric immunoassay; utilizes Roche Modular P analyzer; reagents for quantitative determination of Cystatin C in serum/plasma; automated clinical chemistry platform.

Indications for Use

Indicated for quantitative determination of Cystatin C in human serum, lithium heparin plasma, and EDTA plasma to aid in diagnosis and treatment of renal diseases. 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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

The Binding Site Ltd. c/o Mr. Jay H. Geller West Tower Suite 4000 2425 West Olympic Boulevard Santa Monica CA 90404

K080384 Rc: Trade/Device Name: Human Cystatin C kit For Use on the Modular P Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: NDY Dated: April 24, 2008 Received: April 28, 2008

JUN - 6 2008

Dear Mr. Geller:

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).

{1}------------------------------------------------

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

{2}------------------------------------------------

## Indication for Use

510(k) Number (if known): K080384

Bevice Name: Human Cystatin C kit For Use on the Modular P

Indication For Use: This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

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

C

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

510(k) K080384

Attachment O