(30 days)
No
The summary describes a chromogenic assay with optimized reagent volumes and mentions no AI/ML terms or concepts.
No
The device is described as an "automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma" and is intended "for in vitro diagnostic use," which means it is used to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section states that the device is "an aid in the diagnosis of hereditary and acquired Antithrombin deficiency".
No
The device is described as a modified version of a reagent kit for an automated chromogenic assay, intended for use on specific coagulation systems. This indicates it is a chemical reagent product, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
N/A
Intended Use / Indications for Use
Hemos L Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400).
This modification does not alter the fundamental scientific technology of the device or its intended use as 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.
For in vitro diagnostic use.
Product codes
JBQ
Device Description
HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Within run and between run precision assessed over multiple runs using normal and two abnormal levels of control plasmas gave the results below:
| Control Level | n | Mean % AT | Within Run %CV | Between Run %CV |
|---|---|---|---|---|
| Normal | 60 | 100.85 | 2.5 | 3.4 |
| Low Abnormal | 60 | 32.80 | 4.4 | 4.9 |
| High Abnormal | 60 | 21.82 | 6.4 | 7.4 |
The following results were obtained in a method comparison study comparing HemosIL Liquid Antithrombin XL to the legally marketed HemosIL Antithrombin (K980499): (table data truncated in source document)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
K033775
Section 3 HemosIL Liquid Antithrombin XL 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
December 2, 2003
Name of the Device:
HemosIL Liquid Antithrombin XL
Classification Name:
| 864.7060 | Antithrombin III Assay | Class II |
|---|---|---|
| 81JBQ | Antithrombin III Quantitation |
Identification of predicate device:
K980499 HemosIL Antithrombin
Description of the modified device:
HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The modified HemosIL Liquid Antithrombin XL is substantially equivalent in performance, intended use, safety and effectiveness to HemosIL Antithrombin (K980499).
Summary of Performance Data:
Within run and between run precision assessed over multiple runs using normal and two abnormal levels of control plasmas gave the results below:
| Control Level | n | Mean
% AT | Within Run
%CV | Between Run
%CV |
|---------------|----|--------------|-------------------|--------------------|
| Normal | 60 | 100.85 | 2.5 | 3.4 |
| Low Abnormal | 60 | 32.80 | 4.4 | 4.9 |
| High Abnormal | 60 | 21.82 | 6.4 | 7.4 |
The following results were obtained in a method comparison study comparing HemosIL Liquid Antithrombin XL to the legally marketed HemosIL Antithrombin (K980499):
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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 consists of a stylized eagle with three lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around it. The eagle is facing to the left and the text is in all capital letters.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 2 2004
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
K033775 Trade/Device Name: HemosIL Liquid Antithrombin XL Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III assay Regulatory Class: Class II Product Code: JBQ Dated: December 2, 2003 Received: December 3, 2003
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.
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).
2
Page 2 --
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.
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K033775
Device Name: HemosIL Liquid Antithrombin XL
Indications for Use:
Hemos L Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400).
This modification does not alter the fundamental scientific technology of the device or its intended use as 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.
For in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i. P. Erwin
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K033775
Prescription Use
(Per 21 CFR 801.019)
OR Over-The-Counter Use
Special 510(k): HemosIL Liquid Antithrombin XL