HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS

K081827 · The Binding Site, Ltd. · CFN · Dec 19, 2008 · Immunology

Device Facts

• Record ID: K081827
• Device Name: HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
• Applicant: The Binding Site, Ltd.
• Product Code: CFN · Immunology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPA_PLUS(TM) turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Device Story

The Human IgA Liquid Reagent Kit is an in vitro diagnostic assay designed for use on the Binding Site SPAPLUS turbidimetric analyzer. The device utilizes turbidimetric technology to measure human IgA concentrations in serum, lithium heparin, or EDTA plasma samples. The analyzer processes the samples by mixing them with specific reagents to induce agglutination, which is then measured optically. The resulting quantitative output provides clinicians with IgA levels to assist in diagnosing abnormal protein metabolism and immune system deficiencies. The device is intended for use in clinical laboratory settings by trained personnel. Results are intended to be interpreted alongside other clinical and laboratory findings to support patient diagnosis and management.

Clinical Evidence

No clinical studies provided. Analytical performance established via bench testing: intra-assay precision (CV 0.7-1.0%) and inter-assay precision (CV 1.0-1.7%). Linearity confirmed across 0.2-7.0 g/L range (r=0.999). Method comparison against predicate (n=145) showed slope 0.963, intercept 0.086, r=0.995. Matrix comparison (serum vs. lithium heparin/EDTA plasma) showed no significant bias. Reference range established using 258 healthy adult samples (0.85-4.99 g/L).

Technological Characteristics

Turbidimetric immunoassay; sheep anti-IgA antisera; liquid reagents with 0.099% sodium azide preservative. Measuring range 0.2-7.0 g/L. Traceable to CRM 470. Instrument-based (SPA_PLUS analyzer). Performance evaluated per CLSI EP-5A.

Indications for Use

Indicated for the quantitative determination of human IgA in serum, lithium heparin, or EDTA plasma 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## DEC 1 9 2008

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

Re: k081827

Trade/Device Name: Human IgA Liquid Reagent Kit for use on SPAPLUS™ Regulation Number: 21 CFR 866.5510 Regulation Namc: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFN Dated: June 23, 2008 Received: August 27, 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). This letter

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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 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" (21CFR 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 device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Josephine Bautista
Marfa M. Chan, Ph.D.

Acting Division 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

510(k) Number (if known): K081827

Device Name: Human IgA liquid reagent kit for use on SPAPLUS™

Indications for Use: This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPIJS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

ù 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)

Josephine Bautista
Division Sign-Off

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Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) 081827

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