HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

K140664 · The Binding Site Group , Ltd. · DEB · Apr 16, 2014 · Immunology

Device Facts

• Record ID: K140664
• Device Name: HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: DEB · Immunology
• Decision Date: Apr 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5620
• Device Class: Class 2

Intended Use

This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Human alpha-2-Macroglobulin kit is an in vitro diagnostic reagent system designed for use on the SPAPLUS turbidimetric analyzer. It measures alpha-2-Macroglobulin levels in human serum samples. The device utilizes turbidimetric analysis to quantify the protein concentration. The system is intended for use in clinical laboratory settings by trained laboratory personnel. Results are provided to clinicians to assist in the diagnosis of blood-clotting or clot lysis disorders. The output is used in conjunction with other clinical and laboratory findings to support patient management decisions.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and performance validation for the quantitative measurement of alpha-2-Macroglobulin on the SPAPLUS analyzer.

Technological Characteristics

Turbidimetric immunoassay kit for use on the SPAPLUS analyzer. Measures alpha-2-Macroglobulin in human serum. Operates via light scattering/turbidimetry principles. Designed for professional clinical laboratory use.

Indications for Use

Indicated for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum to aid in the diagnosis of blood-clotting or clot lysis disorders. For prescription use only.

Regulatory Classification

Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

April 16, 2014

The Binding Site Group, Ltd c/o Mr. Jon Lauder Regulatory Affairs Specialist 8 Calthorpe Road Edgbaston, Birmingham B15 1QT United Kingdom

Re: k140664

Trade/Device Name: Human alpha-2-Macroglobulin kit for use on SPAPLUS Regulation Number: 21 CFR 866.5620 Regulation Name: Alpha-2-macroglobulin immunological test system Regulatory Class: II Product Code: DEB Dated: March 13, 2014 Received: March 18, 2014

Dear Mr. Lauder:

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. 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Jon Lauder

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K 140664

Device Name

Human alpha2-Macroglobulin Kit for use on SPAPLUS

#### Indications for Use (Describe)

This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Maria M. Chan -S

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