(190 days)
Not Found
No
The summary describes a standard automated chromogenic assay for measuring Antithrombin levels, with no mention of AI or ML technologies. The performance studies focus on method comparison and precision, typical for laboratory assays, and do not indicate the use of AI/ML for data analysis or interpretation.
No
This device is an in vitro diagnostic test used for quantitative determination of Antithrombin to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "an aid in the diagnosis of hereditary and acquired Antithrombin deficiency." This explicitly indicates its diagnostic purpose.
No
The device description clearly states it is an "automated chromogenic assay" and an "in vitro diagnostic test based on a synthetic chromogenic substrate and on Factor Xa inactivation." This indicates a chemical-based assay requiring reagents and likely hardware for processing and measurement, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation."
The "Device Description" section also states: "This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation."
These statements clearly identify the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
IL Test™ 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.
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 (comma separated list FDA assigned to the subject device)
JBQ
Device Description
IL Test™ 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.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
In method comparison studies evaluating 118 citrated plasma samples (40 normals and 78 abnormals) on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ Liquid Antithrombin versus the predicate device are shown below:
- IL System: ACL 6000, Slope: 0.99, r: 0.995
- IL System: ACL Futura, Slope: 1.01, r: 0.994
Within Run Precision:
Within run precision assessed over multiple runs using three levels of control plasma gave the following results:
ACL 6000:
- Normal Level: Mean (% Activity) 102.6, % CV 2.54
- Abnormal Level I: Mean (% Activity) 53.6, % CV 3.27
- Abnormal Level II: Mean (% Activity) 22.1, % CV 7.54
ACL Futura: - Normal Level: Mean (% Activity) 104.6, % CV 2.10
- Abnormal Level I: Mean (% Activity) 54.2, % CV 2.47
- Abnormal Level II: Mean (% Activity) 25.2, % CV 12.10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, r, Mean (% Activity), % CV
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.
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.
Not Found
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).
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
994238
Section 3 IL Test™ Liquid Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
December 15, 1999 (Revised April 11, 2000)
Name of the Device:
IL Test™ Liquid Antithrombin
Classification Name(s):
| 864.7060 | Antithrombin III Assay | Class II |
|---|---|---|
| 81JBQ | Antithrombin III Quantitation |
Identification of Predicate Device(s):
K980499 IL Test™ Antithrombin
Description of the Device/Intended use(s):
IL Test™ 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.
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.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
IL Test™ Liquid Antithrombin uses the same test principle as the predicate device (IL Test™ Antithrombin) and is substantially equivalent in performance, intended use and safety and effectiveness.
1
Section 3 IL Test™ Liquid Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating 118 citrated plasma samples (40 normals and 78 abnormals) on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ Liquid Antithrombin versus the predicate device are shown below:
| New Device vs. Predicate Device | ||
|---|---|---|
| IL System | Slope | r |
| ACL 6000 | 0.99 | 0.995 |
| ACL Futura | 1.01 | 0.994 |
Within Run Precision
Within run precision assessed over multiple runs using three levels of control plasma gave the following results:
| Normal | Abnormal | Abnormal | ||
|---|---|---|---|---|
| ACL 6000 | Level | Level | Level I | Level II |
| Mean (% Activity) | 102.6 | 53.6 | 22.1 | |
| % CV | 2.54 | 3.27 | 7.54 | |
| ACL Futura | Level | Level | Level I | Level II |
| Mean (% Activity) | 104.6 | 54.2 | 25.2 | |
| % CV | 2.10 | 2.47 | 12.10 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract caduceus, a symbol often associated with healthcare, featuring three wavy lines.
JUN 2 3 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Manager, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K994238
Trade Name: IL Test™ Liquid Antithrombin Regulatory Class: II Product Code: JBQ Dated: April 11, 2000 Received: April 12, 2000
Dear Ms. Marble:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to obegin mantening , puivalence of your device to a legally marketed noutleation. The FDF Intentig of castion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific advices), please contact devices), please contact the Office of Compliance at additionally 007.10 for mintes are questions on the promotion and advertising of your device, (301) 594-4566. Truditionally, for quest at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsionnes and institute and more (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): 994238
Device Name: IL Test™ Liquid Antithrombin
Indications for Use:
IL Test™ 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.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign (Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K994238 |
| Prescription Use (Per 21 CFR 801.019) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| --------------------------------------- | -- | ---- | ---------------------- | -- |
Section 2 IL Test™ Liquid Antithrombin 510(k) Page 1 of 1