HUMAN IGM CSF KIT

K120750 · The Binding Site Group , Ltd. · CFN · May 17, 2013 · Immunology

Device Facts

• Record ID: K120750
• Device Name: HUMAN IGM CSF KIT
• Applicant: The Binding Site Group , Ltd.
• Product Code: CFN · Immunology
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Human IgM CSF kit for use on SPAPLUS is intended for the quantitative measurement of human IgM in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.

Device Story

The Human IgM CSF kit is an in vitro diagnostic reagent system designed for use on the SPAplus analyzer. It measures human IgM concentrations in cerebrospinal fluid (CSF) samples. The device utilizes immunoturbidimetric technology to quantify IgM levels. It is intended for use in clinical laboratory settings by trained personnel. The output is a quantitative IgM value, which healthcare providers use alongside other clinical and laboratory data to assess a patient's immune status and ability to resist infectious diseases.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=84 for serum, 5-day study for CSF). Linearity evaluated per CLSI EP06-A (R2=0.99-1.00). Analytical sensitivity (LoD 0.0322 mg/L, LoQ 0.2463 mg/L) and specificity (no interference from hemoglobin, bilirubin, acetaminophen, or aspirin) established. Method comparison with predicate (n=58) yielded y=1.08x-0.02.

Technological Characteristics

Turbidimetric assay; sheep anti-human IgM antibody. Measuring range 0.3–7.0 mg/L (1/1 dilution) and 3.0–70.0 mg/L (1/10 dilution). Instrument: SPAPLUS analyzer. Calibration/controls traceable to ERM-DA470k. Reagent stability: 18 months closed, 2 months open, 30 days on-board at 8-12°C.

Indications for Use

Indicated for the quantitative measurement of human IgM in cerebrospinal fluid (CSF) to aid in the assessment of the body's ability to resist infectious disease. 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.

Predicate Devices

• Siemens (Dade Behring) N Latex IgM (k032014)

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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2013

THE BINDING SITE GROUP LTD C/O DR. JILL CONSTANTINE REGULATORY SCIENTIST 8 CALTHORPE ROAD EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: K120750

Trade/Device Name: Human IgM CSF Kit for Use on SPAplus Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: CFN Dated: April 19, 2013 Received: April 22, 2013

Dear Dr. Constantine:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

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 Parts 801 and 809); medical device reporting (reporting of medical 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

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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 regulations (21 CFR Parts 801 and 809), please contact 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. 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/Reportal?roblem/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 -S

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

Enclosure

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## Indications for Use

510(k) Number (if known): k120750

Device Name: Human IgM CSF kit for use on SPAPLUS

Indications For Use:

Human IgM CSF kit for use on SPAPLUS is intended for the quantitative measurement of human IgM in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease 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 807 Subpart C) 1

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

## Maria MD @han -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): k120750