(169 days)
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Not Found
No
The summary describes a standard in vitro diagnostic assay using immunoturbidometry, with no mention of AI or ML terms or concepts.
No
Explanation: This device is described as an "in vitro diagnostic automated immunoturbidometric assay," indicating it is used for testing human samples, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic automated immunoturbidometric assay."
No
The device is described as an "in vitro diagnostic automated immunolurbidometric assay" for use on "IL Coagulation Systems." This description strongly implies a physical assay kit and a hardware system (IL Coagulation Systems) are involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement directly identifies the device as an in vitro diagnostic assay.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines resembling a bird in flight or a caduceus. The emblem is positioned in the center of the seal, creating a visual representation of the Department of Health and Human Services.
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Image /page/2/Picture/14 description: The image shows the name "Leonthena R. Carrington-S" in a bold, sans-serif font. The letters "FDA" are stacked on top of each other in a decorative, outlined font. The name appears to be a signature or title, possibly associated with the FDA.
FORM FDA 3881 (9/13)
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PLC Publishing Berviews (141) 443-4740
Instrumentation Laboratory
COMPANY CONFIDENTIAL
Page 14 of 17
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