HEMOSIL VON WILLEBRAND ACTIVITY ASSAY

K133005 · Instrumentation Laboratory CO · GGP · Mar 13, 2014 · Hematology

Device Facts

• Record ID: K133005
• Device Name: HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Mar 13, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

IL Hemosil. von Willebrand Activity is an in vitro diagnostic automated immunolurbidometric assay for the quantitative determination of von Willebrand activity in human citrated plasma on IL Coagulation Systems.

Device Story

HemosIL von Willebrand Activity is an in vitro diagnostic assay used to measure von Willebrand factor activity in human citrated plasma. The device utilizes an automated immunoturbidometric method performed on Instrumentation Laboratory (IL) Coagulation Systems. The assay provides quantitative results to clinicians, aiding in the assessment of von Willebrand factor function. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output assists healthcare providers in diagnosing or monitoring conditions related to von Willebrand factor deficiency or dysfunction.

Clinical Evidence

No clinical data provided; modification is limited to labeling updates regarding interfering substances.

Technological Characteristics

In vitro diagnostic reagent kit for automated coagulation analyzers. Fundamental technology unchanged from predicate K040843.

Indications for Use

Indicated for the quantitative determination of von Willebrand factor activity in human citrated plasma on automated coagulation analyzers.

Submission Summary (Full Text)

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## DEPARTMENT 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

March 13, 2014

INSTRUMENTATION LABORATORY COMPANY C/O MS. JACQUELINE EMERY REGULATORY AFFAIRS MANAGER 180 HARTWELL ROAD BEDFORD MA 01730

Re: K133005

Trade/Device Name: HemosIL von Willebrand Activity Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: II Product Code: GGP Dated: February 3, 2014 Received: February 11, 2014

Dear Ms. Emery:

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-Ms. Jacqueline Emery

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/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 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-FMDochan-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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HemosiL von Willebrand Activity Kit

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on fast page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133005

Device Name HemosIL von Willebrand Activity

Indications for Use (Describe)

IL Hemosil. von Willebrand Activity is an in vitro diagnostic automated immunolurbidometric assay for the quantitative determination of von Willebrand activity in human citrated plasma on IL Coagulation Systems.

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

> 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.

2017-02-04 FOR FOR FDA USE ONLY .. Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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FORM FDA 3881 (9/13)

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PLC Publishing Berviews [phone]

Instrumentation Laboratory

COMPANY CONFIDENTIAL

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