HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

K100588 · The Binding Site Group , Ltd. · CFN · Aug 16, 2010 · Immunology

Device Facts

• Record ID: K100588
• Device Name: HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: CFN · Immunology
• Decision Date: Aug 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for quantifying IgA Subclass 1 (IgA1) in serum using The Binding Site SPAPlus turbidimetric analyser. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

Device Story

The Human IgA1 and IgA2 Kits are in vitro diagnostic reagents for use on the SPAPLUS turbidimetric analyzer. The device utilizes specific antisera (sheep anti-human IgA1 and IgA2) to react with IgA subclasses in human serum samples, forming insoluble complexes. As light passes through the suspension, the analyzer measures transmitted light, which is inversely proportional to the protein concentration. The instrument automatically calculates concentrations using a stored calibration curve. The device is intended for use in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing abnormal protein metabolism and immune deficiencies. The system provides quantitative measurements, enabling clinicians to monitor patient immunoglobulin levels and inform clinical decision-making regarding immune function and metabolic health.

Clinical Evidence

No clinical studies were performed. Analytical performance was established via bench testing, including precision (CLSI EP5-A2), linearity (CLSI EP6-A), and limit of detection/quantitation (CLSI EP17-A). Method comparison studies against the predicate device (n=112 for IgA1; n=89 for IgA2) showed strong correlation (r=0.980 for IgA1; r=0.994 for IgA2). Interference testing confirmed no significant impact from bilirubin, hemoglobin, or chyle.

Technological Characteristics

Turbidimetric immunoassay reagents for use on the SPAPlus automated analyzer. Measures IgA1 and IgA2 subclasses in serum. Class II device, product code CFN.

Indications for Use

Indicated for the quantification of IgA1 and IgA2 subclasses in human serum to aid in the diagnosis of abnormal protein metabolism and immune deficiency. For prescription use only.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Submission Summary (Full Text)

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SEP 1 4 2010

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

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: k100588

Trade/Device Name: Human IgA1 Kit for use on SPAPLUS™ Human IgA2 Kit for use on SPAPLUSTM Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFN Dated: June 24, 2010 Received: June 29, 2009

Dear Mr. Geller:

This letter corrects our substantially equivalent letter of 8/16/2009.

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

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Page 2 – Mr. Jay H. Geller

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRH/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 vours.

Mana in 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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## Indications for Use

K100588

AUG 1 6 2010

k 100588 510(k) Number (if known):

Device Name: Human IgA1 Kit for use on the SPAPIus™

Indications for Use: This kit is intended for quantifying IgA Subclass 1 (IgA1) in serum using The Binding Site SPAPlus turbidimetric analyser. Measurement of this immunoglobulin aids in the diagnosis of abnor

mal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

Prescription Use X (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 In Vitro Diagnostic Devices (OIVD).

Mana M Chan
Division Sign-Off

Attachment 13

Device Evaluation and

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510(k) Klooaff

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## Indications for Use

K100588

AUG 1 6 2010

k100588 510(k) Number (if known):

Device Name: Human IgA2 Kit for use on the SPAPlus™

Indications for Use: This kit is intended for quantifying IgA Subclass 2 (IgA2) in serum using The Binding Site SPAPlus turbidimetric analyser. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings..

Prescription Use X (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 In Vitro Diagnostic Devices (OIVD).

Mina M. Chan

**Division Sign-Off**

Attachment 14

**Office of In Vitro Diagnostic Device Evaluation and Safety**

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510(k) K100587