SPAPLUS

K100179 · The Binding Site Group , Ltd. · CZW · Aug 13, 2010 · Immunology

Device Facts

• Record ID: K100179
• Device Name: SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: CZW · Immunology
• Decision Date: Aug 13, 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 C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Human C3c Kit is an in vitro diagnostic reagent system designed for use on the Binding Site SPAPLUS™ turbidimetric analyzer. The device measures C3c concentrations in human serum samples. Operation involves the turbidimetric analysis of antigen-antibody reactions; the analyzer processes the sample and provides a quantitative result. The device is intended for use by laboratory professionals in clinical settings to assist in the assessment of complement components. Results are interpreted by clinicians alongside other laboratory and clinical findings to support patient diagnosis and management.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-A2) showed total CVs < 7%. Linearity (CLSI EP6-A) confirmed performance across 0.03-3 g/L. Method comparison with the predicate using 92 retrospective human serum samples yielded a Passing and Bablok fit of y = 0.99x + 0.00 (R²=0.99). Interference testing showed no significant impact from bilirubin, hemoglobin, or chyle.

Technological Characteristics

Turbidimetric immunoassay for quantitative determination of C3c. Designed for use on the SPAPLUS™ analyzer. Class II device under 21 CFR 866.5240.

Indications for Use

Indicated for the quantitative in vitro determination of human C3c in serum to aid in the assessment of complement components in clinical laboratory settings.

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

SEP 1 4 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: k100179

Trade/Device Name: Human C3c Kit for use on SPAPLUSTM Regulation Number: 21 CFR §866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW Dated: August 2, 2010 Received: August 9, 2009

Dear Mr. Geller:

This letter corrects our substantially equivalent letter of 8/13/2009.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jay H. Geller

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria 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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K100179

## Indications for Use

.

AUG 1 3 2010

510(k) Number (if known): K100179

Device Name: Human C3c Kit for use on SPAPLUSTM

Indications for Use: This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manaí In Chan Attachment D
Division Sign-Off

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Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) K100179

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