(11 days)
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No
The summary describes a standard automated chromogenic assay for quantitative determination of Antithrombin, with no mention of AI or ML technologies in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as an "in vitro diagnostic test" used for diagnosis and monitoring, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency." This indicates its role in the diagnostic process.
No
The device is an in vitro diagnostic assay, which involves chemical reagents and is used with an automated system, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma..." This indicates it's a test performed on a biological sample (plasma) outside of the body.
- "This in vitro diagnostic test is based on a synthetic chromogenic substrate..." This directly identifies it as an in vitro diagnostic test.
- "...as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy." This describes its intended medical purpose, which is a key characteristic of an IVD.
N/A
Intended Use / Indications for Use
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa Inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
Product codes
JBQ
Device Description
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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Predicate Device(s)
K033775 HemosIL Liquid Antithrombin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).
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510(k) Summary HemosIL Liquid Antithrombin
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone No.: 781-861-4467 Fax No .: 781-861-4207
Summary Prepared:
August 17, 2006
Name of the Device:
HemosIL Liquid Antithrombin
Regulatory Information:
| 864.7060 | Antithrombin III Assay |
|---|---|
| 81JBQ | Antithrombin III Quantitation |
Class II
Identification of Predicate Device(s):
K033775 HemosIL Liquid Antithrombin
Device Description:
1
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
Reason for Submission:
The Expected Values section of the HemosIL Liquid Antithrombin inserts (same formulation, different kit configuration size) are being modified to reference a normal range from published literature, reinforcing the need for each laboratory to establish its own normal [reference] range due to the many variables which may affect results.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Liquid Antithrombin with the modified Expected Values section in the product inserts is not materially different from the FDA cleared device.
Summary of Expected Values Section to the Modified Product Insert:
Antithrombin activity levels in healthy individuals are approximately in the range of 83 – 128%. Antithrombin levels are low in neonates/infants and increase to adult levels by approximately 1. year of age; levels are then slightly higher than in adults up to age 16 year.*
Due to many variables which may affect results, each laboratory should establish its own normal range.
-
- Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336.
Section 3
- Kottke-Marchant K, Duncan A. Antithrombin Deficiency: Issues in Laboratory Diagnosis, Arch Pathol Lab Med. 2002; 126:1326-1336.
Special 510(k): HemosIL Liquid Antithrombin
SEP - 1 2006
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
Re: K062431
Trade/Device Name: HemosIL Liquid Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin Regulatory Class: II Product Code: JBQ Dated: August 18, 2006 Received: August 21, 2006
Dear Ms. 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. 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.
SEP - 1 2006
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobent Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ___ |