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Carol Marble Sr. Regulatory Affairs Director Trade/Device … - i 864 form pdf
October 4, 2022
Instrumentation Laboratory Co.
Carol Marble
Sr. Regulatory Affairs Director
180 Hartwell Road
Bedford, Massachusetts 01730
Re: K213464
Trade/Device Name: HemosIL Liquid Anti-Xa
Regulation Number: 21 CFR 864.7525
Regulation Name: Heparin Assay
Regulatory Class: Class II
Product Code: KFF, QLU
Dated: June 3, 2022
Received: June 6, 2022
Dear Carol Marble:
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. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. 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
U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 5 . 0 0
Silver Spring, MD 20993
www.fda.gov
K213464 - Carol Marble Page 2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Min Wu -S
Min Wu
Branch Chief
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.
510(k) Number (ifknown)
Device Name
HemosL Liquid Anti-Xa
Indications for Use (Describe)
HemoslL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in
clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes
based on the calibrators used:
*When used with HemoslL Heparin Calibrators:
Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on
the ACL TOP Family and ACL TOP Family 50 Series.
*When used with HemoslL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement
of Factor Xa activity, which is inversely proportional to the apixaban level. With HemoslL Apixaban Calibrators, the
assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where
measurement of apixaban levels could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory
findings.
For use in adult population. For prescription use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) E Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number"
FORM FDA 3881 (6120) Page 1 of 1 PSC PublisAing Servics (301) 443-6740 EF
What is the difference between form I 864 and i864a? What is the difference between I-864 and i864a? The joint sponsor will submit a separate Form I-864, Affidavit of Support in addition to the main sponsor’s I-864. Unlike a household member, a joint sponsor is not contributing to the main sponsor’s total household income. Regardless, he will submit Form I-864 on behalf of his spouse.
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