OPTILITE C1 INACTIVATOR KIT

K141100 · The Binding Site Group , Ltd. · DBA · Jul 18, 2014 · Immunology

Device Facts

• Record ID: K141100
• Device Name: OPTILITE C1 INACTIVATOR KIT
• Applicant: The Binding Site Group , Ltd.
• Product Code: DBA · Immunology
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5250
• Device Class: Class 2

Intended Use

The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

Device Story

Optilite C1 Inactivator kit is an in vitro diagnostic assay for quantitative measurement of human C1 Inactivator in serum. Used on Binding Site Optilite analyzer; operates via immunoturbidimetric principle. Input: human serum sample; Output: quantitative C1 Inactivator concentration. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing hereditary angioedema (HAE) when combined with other clinical/laboratory data.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and performance validation of the assay on the Optilite analyzer.

Technological Characteristics

Quantitative immunoturbidimetric assay. Reagents: sheep anti-human C1 inactivator antiserum, stabilized with sodium azide, EACA, EDTA, and benzamidine. Instrument: Binding Site Optilite analyzer (automated benchtop). Detection: photodiode-based optical lens system measuring light transmission. Traceability: ERM-DA470k. Software: automated calibration and QC programs. Sterilization: not applicable (reagents).

Indications for Use

Indicated for the quantitative measurement of human C1 inactivator in serum to aid in the diagnosis of hereditary angioedema (HAE) in adults. Prescription use only.

Regulatory Classification

Identification

A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Submission Summary (Full Text)

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# EPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 18, 2014

THE BINDING SITE GROUP, LTD. MS. MARIANNE SENDER, REGULATORY AFFAIRS SPECIALIST 8 CALTHORPE ROAD EDGBASTON, BIRMINGHAM WEST MIDLANDS B15. IQT UK

Re: k141100

Trade/Device Name: Optilite C1 Inactivator Regulation Number: 21 CFR 866.5250 Regulation Name: Complement C1 inhibitor (inactivator) immunological test system Regulatory Class: II Product Code: DBA Dated: July 15, 2014 Received: July 18, 2014

Dear Ms. Sender:

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 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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Page 2-Ms. Marianne Sender

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 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" (21 CFR 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/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

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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) k141100

Device Name Optilite C1 Inactivator kit

#### Indications for Use (Describe)

The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Maria M. Chan -S

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