SPAPLUS ANALYZER

K100455 · The Binding Site · DBI · Sep 3, 2010 · Immunology

Device Facts

• Record ID: K100455
• Device Name: SPAPLUS ANALYZER
• Applicant: The Binding Site
• Product Code: DBI · Immunology
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings

Device Story

Human C4 Kit is an in vitro diagnostic reagent system for use on the Binding Site SPAPLUS turbidimetric analyzer. The device measures C4 complement component levels in human serum samples. Principle of operation involves turbidimetric analysis where antigen-antibody complexes form, causing light scattering proportional to C4 concentration. The analyzer processes the sample, performs the measurement, and provides a quantitative result. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in assessing complement system status and diagnosing related immunological conditions.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the assay on the SPAPLUS analyzer.

Technological Characteristics

Turbidimetric immunoassay. Reagents: sheep anti-human C4 serum, reaction buffer, human serum-based calibrators/controls. Instrument: SPAPLUS™ (Clinical Chemistry Analyzer). Connectivity: standalone instrument. Software: minor level of concern; same as Prestige 24i/Sirrus. Sterilization: N/A (reagents).

Indications for Use

Indicated for the quantitative in vitro determination of human C4 in serum for adult patients. No pediatric range is established.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is black, and the text is also black.

## Public Health Service

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

SEP 0 3 2010

The Binding Site Group, Ltd. c/o Mr. Jay H. Geller Authorized U.S. Representative 12100 Wilshire Boulevard. Suite 500 Los Angeles, CA 90025-7121

Re: k100455

Trade/Device Name: Human C4 Kit for use on SPAPLUSTM Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: II Product Code: DBI Dated: August 25, 2010 Received: August 26, 2010

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 class II (Special Controls), 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

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## Page 2 - Mr. Jay H. Geller

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K100455

510(k) Number (if known): k100455

SEP 0 3 2010

Device Name: Human C4 Kit for use on SPAPLUS™

Indications For Use:

0

This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K k100455