HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

K123256 · The Binding Site Group , Ltd. · DEM · Jul 3, 2013 · Immunology

Device Facts

• Record ID: K123256
• Device Name: HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
• Applicant: The Binding Site Group , Ltd.
• Product Code: DEM · Immunology
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Human alpha-1 Antitrypsin Kit is an in vitro diagnostic reagent system used on the SPAPLUS turbidimetric analyzer. It measures alpha-1-antitrypsin levels in human serum samples. The device utilizes turbidimetric immunoassay principles; antigen-antibody complexes form in the presence of the reagent, causing turbidity proportional to the concentration of alpha-1-antitrypsin in the sample. The analyzer measures this turbidity to provide a quantitative result. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing liver cirrhosis and pulmonary emphysema associated with alpha-1-antitrypsin deficiency. The test is intended to be used alongside other clinical and laboratory findings to support patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance characteristics of the assay on the SPAPLUS platform.

Technological Characteristics

Turbidimetric immunoassay; quantitative measurement of alpha-1-antitrypsin in human serum; designed for use on the SPAPLUS analyzer platform. Class II device (21 CFR 866.5130).

Indications for Use

Indicated for quantitative in vitro determination of alpha-1-antitrypsin in human serum to aid in diagnosis of conditions including adult liver cirrhosis and pulmonary emphysema associated with alpha-1-antitrypsin deficiency. For prescription use.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a circular seal with the logo of the Department of Health and Human Services (DHHS) of the United States. The seal features the DHHS emblem, which consists of a stylized caduceus with three branches, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion.

Public Health Service

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

July 3, 2013

The Binding Site Group Ltd. c/o Jill Constantine, Ph.D. FDA Submissions Manager 8 Calthorpe Road. Edgbaston Birmingham. West Midlands United Kingdom B15 IQT

Rc: k123256

Trade/Device Name: Human alpha-1 Antitrypsin Kit for use on SPAPLUS Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-antitrypsin immunological test system Regulatory Class: II Product Code: DEM Dated: May 30, 2013 Received: May 30, 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, 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 classilied (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 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2-Dr. Jill Constantine

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/Resources/orYou/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/Safetw/ReportalProblem/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 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

k123256 510(k) Number (if known):

Human alpha-1 Antitrypsin Kit for use on SPAPLUS Device Name:

Indications For Use:

The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 M. Chan -S

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

510(k): k123256