HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER

K082129 · The Binding Site, Ltd. · CFN · Feb 10, 2009 · Immunology

Device Facts

• Record ID: K082129
• Device Name: HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
• Applicant: The Binding Site, Ltd.
• Product Code: CFN · Immunology
• Decision Date: Feb 10, 2009
• 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 IgM in human serum, heparinized or EDTA plasma, using the Binding Site SPA_PLUS turbidimetric analyser. Measurement of IgM 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 IgM Kit is an in vitro diagnostic reagent system designed for use on the Binding Site SPAPLUS turbidimetric analyzer. It utilizes turbidimetric technology to measure IgM concentrations in human serum, heparinized plasma, or EDTA plasma samples. The device is operated by laboratory professionals in a clinical setting. The analyzer processes the samples and reagents to produce quantitative IgM results. These results assist clinicians in diagnosing conditions related to abnormal protein metabolism and the body's ability to resist infectious agents.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A (n=84); total CVs ranged from 2.1% to 6.2%. Linearity confirmed over 0.2–7.5 g/L range (R^2=0.98). Method comparison with predicate (n=71) showed Passing-Bablok regression y = 1.01x - 0.02 (R^2=0.994). Matrix comparison (serum vs. heparin/EDTA plasma) showed high correlation (r=0.998 and r=0.999). Analytical specificity demonstrated no significant interference from bilirubin, hemoglobin, Rheumatoid Factor, or chyle.

Technological Characteristics

Turbidimetric immunoassay reagent kit. Designed for use on the SPAPLUS automated analyzer. Measures IgM via light scattering/turbidimetry. Reagents are liquid-stable. System is intended for professional in vitro diagnostic use.

Indications for Use

Indicated for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma to aid in the diagnosis of abnormal protein metabolism and immune deficiency in patients.

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.

Predicate Devices

• Roche Tina-quant IgM Gen 2 (k040431)

Submission Summary (Full Text)

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 0 2009

Re: k082129

Trade/Device Name: Human IgM Kit for use on the SPAPLUSTM Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: CFN, JIT, JJX Dated: January 14, 2009 Received: January 15, 2009

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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding

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

### Page 2 – Mr. Jay H. Geller

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.

ia In Cham

Maria 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

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

# Indication for Use

510(k) Number (if known): K082129

## Device Name: Human IgM LIQUID REAGENT KIT for use on SPAPLUS™

Indication For Use: This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

メ Prescription Use (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 (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082129

Page 1 of 1

10