(55 days)
Not Found
No
The description focuses on a standard in vitro diagnostic assay based on chemical reactions and automated analysis, with no mention of AI/ML terms or concepts.
No
This device is an in vitro diagnostic test used for quantitative determination of heparin activity in human plasma, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "IL Test™ Heparin is an in vitro diagnostic test."
No
The device description clearly states it is an "in vitro diagnostic test" and an "automated heparin assay based on a synthetic chromogenic substrate and Factor Xa inactivation." This indicates it is a chemical assay kit and likely includes reagents and potentially hardware components for automation, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma."
The "Device Description" section also reiterates this: "IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma."
N/A
Intended Use / Indications for Use
IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma. It is an automated heparin assay based on a synthetic chromogenic substrate and Factor Xa inactivation.
Heparin is the most frequently used antithrombotic drug. The biological activity of this sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin on coagulation proteases. In recent years, it has been shown that LMWH, besides being as useful therapeutically as UFH, also has a longer half-life.
Product codes
KFF
Device Description
IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma. It is an automated heparin assay based on a synthetic chromogenic substrate and Factor Xa inactivation.
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 that included samples from patients treated with UFH and LMWH, the correlation (r) of the new IL Test™ Heparin to the predicate IL Test™ Heparin Xa on the ACL 300 was 0.988 (n=98) and on the ACL Futura was 0.989 (n=91).
On the ACL 300, within run precision accessed over multiple runs using 2 levels of the 4th Heparin International Standard, UFH gave a CV of 1.84% (at a mean of 0.77 U/mL) and 7.76% (at a mean of 0.23 U/mL). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of the 4th Heparin International Standard, UFH gave a CV of 4.06% (at a mean of 0.81 U/mL) and 14.27% (at a mean of 0.21 U/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
0
Section 3
MAR 1 9 1998
IL Test™ Heparin - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue 781 Lexington, MA 02173 Phone: (647) 861-4467 (617) 861-4464 Fax:
Contact Person:
Carol Marble ng Phone: (647) 861-4467
Summary Prepared:
January 22, 1998
Name of the device:
IL Test™ Heparin
Classification name(s):
864.7525 Heparin Assay 81KFF Assay, Heparin Class II
Identification of predicate device(s):
K935212 IL Test™ Heparin Xa
Description of the device/intended use(s):
IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma. It is an automated heparin assay based on a synthetic chromogenic substrate and Factor Xa inactivation.
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The new IL Test™ Heparin uses the same test principle as the predicate IL Test™ Heparin Xa and is substantially equivalent in performance, intended use and safety and effectiveness.
Summary of Performance Data:
In method comparison studies that included samples from patients treated with UFH and LMWH, the correlation (r) of the new IL Test™ Heparin to the predicate IL Test™ Heparin Xa on the ACL 300 was 0.988 (n=98) and on the ACL Futura was 0.989 (n=91).
On the ACL 300, within run precision accessed over multiple runs using 2 levels of the 4th Heparin International Standard, UFH gave a CV of 1.84% (at a mean of 0.77 U/mL) and 7.76% (at a mean of 0.23 U/mL). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of the 4th Heparin International Standard, UFH gave a CV of 4.06% (at a mean of 0.81 U/mL) and 14.27% (at a mean of 0.21 U/mL).
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 19 1998
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
K980242 Re : IL Test™ Heparin Regulatory Class: II Product Code: KFF Dated: January 22, 1998 January 23, 1998 Received:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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
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 Gutman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: IL Test™ Heparin
Indications for Use:
IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma. It is an automated heparin assay based on a synthetic chromogenic substrate and Factor Xa inactivation.
Heparin is the most frequently used antithrombotic drug. The biological activity of this sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin on coagulation proteases. In recent years, it has been shown that LMWH, besides being as useful therapeutically as UFH, also has a longer half-life.
(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 | K980242 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.019) | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------------------------------ | -------------------------------------------------------- | ---- | ---------------------- | ------------------------------------------------------- |
Section 2
IL Test™ Heparin 510(k)