(52 days)
Not Found
No
The summary describes a standard in vitro diagnostic test for quantitative determination of Antithrombin, with no mention of AI, ML, image processing, or any characteristics typically associated with AI/ML-powered devices.
No
This device is an in vitro diagnostic test used to measure antithrombin levels, aiding in diagnosis and monitoring treatment, but it does not directly treat or provide therapy itself.
Yes
The "Intended Use / Indications for Use" states that the device is an "in vitro diagnostic test" and is used "as an aid in the diagnosis of thrombophilia."
No
The device is an in vitro diagnostic test, which involves reagents and laboratory procedures to analyze biological samples, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma..."
The "Device Description" section also reiterates this: "IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma..."
N/A
Intended Use / Indications for Use
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Product codes (comma separated list FDA assigned to the subject device)
JBO, JBQ
Device Description
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In method comparison studies evaluating 52 plasma samples, the correlation (r) was 0.992 for the new IL Test™ Antithrombin on the ACL 300 as compared to the predicate Coamatic® Antithrombin on the Cobas Mira and 0.991 for the new IL Test™ Antithrombin on the ACL Futura as compared to the predicate Coamatic® Antithrombin on the Cobas Mira.
On the ACL 300, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.6% (at a mean of 49.2% activity) and 1.6% (at a mean of 103.7% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.9% (at a mean of 48.7% activity) and 3.0% (at a mean of 104.5% activity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation (r): 0.992, 0.991
CV: 3.6%, 1.6%, 3.9%, 3.0%
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
Section 3 IL Test™ Antithrombin - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
APR - 2 1998
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
February 6, 1998
Name of the device:
IL Test™ Antithrombin
Classification name(s):
| 864.7060 | Antithrombin III Assay | Class II |
|---|---|---|
| 81JBQ | Antithrombin III Quantitation |
Identification of predicate device(s):
Coamatic® Antithrombin (originally named Coamate Antithrombin) K915083
Description of the device/intended use(s):
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The new IL Test™ Antithrombin uses the same test principle as the predicate Coamatic® Antithrombin and is substantially equivalent in performance, intended use and safety and effectiveness.
Summary of Performance Data:
In method comparison studies evaluating 52 plasma samples, the correlation (r) was 0.992 for the new IL Test™ Antithrombin on the ACL 300 as compared to the predicate Coamatic® Antithrombin on the Cobas Mira and 0.991 for the new IL Test™ Antithrombin on the ACL Futura as compared to the predicate Coamatic® Antithrombin on the Cobas Mira.
On the ACL 300, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.6% (at a mean of 49.2% activity) and 1.6% (at a mean of 103.7% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.9% (at a mean of 48.7% activity) and 3.0% (at a mean of 104.5% activity).
Page 1 of 1 IL Test™ Antithrombin 510(k) Section 3
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 1998
Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
K980499 Re : IL Test™ Antithrombin Regulatory Class: II Product Code: JBO Dated: February 6, 1998 Received: February 9, 1998
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
3
Indications for Use Statement
510(k) Number (if known): _ H980499
Device Name: IL Test™ Antithrombin
Indications for Use:
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
(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. K980499
Prescription Use
(Per 21 CFR 801.019)
OR Over-The-Counter Use _
Over-The-Counter Use
Section 2
IL Test™ Antithrombin 510(k)
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