(53 days)
Not Found
No
The summary describes a standard in vitro diagnostic test based on chemical reactions and quantitative measurements, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic test used to measure heparin activity, which aids in monitoring the effectiveness of a therapeutic drug but does not itself provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Coamatic® Heparin is an in vitro diagnostic test."
No
The device is an in vitro diagnostic test kit, which includes reagents and likely other physical components for performing laboratory tests, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "Coamatic® Heparin is an in vitro diagnostic test..." and describes its use for quantitative determination of heparin activity in human plasma. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description reiterates that it is an "in vitro diagnostic test".
- Performance Studies: The performance studies involve testing human plasma samples, which is characteristic of an IVD.
- Predicate Device: The mention of a predicate device (IL Test™ Heparin K980242) which is also an IVD further supports this classification.
N/A
Intended Use / Indications for Use
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.
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.
Product codes (comma separated list FDA assigned to the subject device)
KFF
Device Description
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods.
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)
The results from comparative studies of Coamatic® Heparin on different methods vs. IL Test™ Heparin on an ACL 300 using samples from patients treated with UFH and LMWH are shown below:
| Application | n | Slope | Intercept | r |
|---|---|---|---|---|
| Cobas Mira | 87 | 1.04 | -0.01 | 0.98 |
| Microplate | 70 | 1.00 | 0.02 | 0.97 |
| ACL 300 | 62 | 1.02 | 0.01 | 0.98 |
| ACL Futura | 113 | 0.97 | 0.01 | 0.97 |
| MLA Electra | 80 | 1.01 | 0.00 | 0.97 |
The results from additional comparative studies of Coamatic® Heparin on other methods vs. IL Test™ Heparin on an ACL 300 using normal plasmas and pooled plasmas spiked with UHF heparin are shown below:
| Application | n | Slope | Intercept | r |
|---|---|---|---|---|
| Sysmex 6000 | 30 | 0.91 | 0.06 | 0.99 |
| AMAX | 30 | 0.97 | 0.03 | 0.99 |
| Hitachi 911 | 30 | 0.98 | 0.01 | 0.99 |
| Hitachi 917 | 30 | 1.00 | 0.02 | 0.98 |
Precision data summarized below was obtained with the microplate method using unfractionated heparin (UFH) and low molecular weight heparin (LMWH):
| Within Run | Between Run | Total | |
|---|---|---|---|
| Mean Concentration | %CV | %CV | %CV |
| 0.7 IU/mL UFH | 2.8 | 1.2 | 2.8 |
| 0.4 IU/mL UFH | 3.4 | 1.5 | 3.7 |
| 0.7 IU/mL LMWH | 3.6 | 2.8 | 4.4 |
| 0.4 IU/mL LMWH | 2.4 | 2.3 | 3.2 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 864.7525 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
NOV 3 1998
Section 3 Coamatic® Heparin - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4464
Contact Person:
Carol Marble Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
September 10, 1998
Name of the device:
Coamatic® Heparin
Classification name(s):
| 864.7525 | Heparin Assay | Class II | |
|---|---|---|---|
| 81KFF | Assay, Heparin |
Identification of predicate device(s):
IL Test™ Heparin K980242
Description of the device/intended use(s):
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods.
Statement of How the Technological Characteristics of the Device Compare to the Predicate Device:
The new Coamatic® Heparin is based on a synthetic chromogenic substrate and Factor Xa inactivation, as is the predicate device: IL Test™ Heparin, and is substantially equivalent in its performance, intended use and safety and effectiveness.
Summary of Performance Data:
The results from comparative studies of Coamatic® Heparin on different methods vs. IL Test™ Heparin on an ACL 300 using samples from patients treated with UFH and LMWH are shown below:
| Application | n | Slope | Intercept | r |
|---|---|---|---|---|
| Cobas Mira | 87 | 1.04 | -0.01 | 0.98 |
| Microplate | 70 | 1.00 | 0.02 | 0.97 |
| ACL 300 | 62 | 1.02 | 0.01 | 0.98 |
| ACL Futura | 113 | 0.97 | 0.01 | 0.97 |
| MLA Electra | 80 | 1.01 | 0.00 | 0.97 |
| Section 3 | Coamatic® Heparin 510(k) | Page 1 of 2 |
1
Summary of Performance Data (Continued):
The results from additional comparative studies of Coamatic® Heparin on other methods vs. IL Test™ Heparin on an ACL 300 using normal plasmas and pooled plasmas spiked with UHF heparin are shown below:
| Application | n | Slope | Intercept | r |
|---|---|---|---|---|
| Sysmex 6000 | 30 | 0.91 | 0.06 | 0.99 |
| AMAX | 30 | 0.97 | 0.03 | 0.99 |
| Hitachi 911 | 30 | 0.98 | 0.01 | 0.99 |
| Hitachi 917 | 30 | 1.00 | 0.02 | 0.98 |
Precision data summarized below was obtained with the microplate method using unfractionated heparin (UFH) and low molecular weight heparin (LMWH):
Microplate Method:
| Within Run | Between Run | Total | |
|---|---|---|---|
| Mean Concentration | %CV | %CV | %CV |
| 0.7 IU/mL UFH | 2.8 | 1.2 | 2.8 |
| 0.4 IU/mL UFH | 3.4 | 1.5 | 3.7 |
| 0.7 IU/mL LMWH | 3.6 | 2.8 | 4.4 |
| 0.4 IU/mL LMWH | 2.4 | 2.3 | 3.2 |
NOTE: Instrument-specific precision results are available in the application sheets.
2
September 8, 1998
Image /page/2/Picture/1 description: The image shows the logo for Instrumentation Laboratory. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is a stylized cube-like structure, and the text reads "Instrumentation Laboratory" in a bold, sans-serif font.
PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT [AS REQUIRED BY 21 CFR 807.87(j)]
I certify that, in my capacity at Instrumentation Laboratory Company, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
William Wood
Signature
Signature
William Wood Name
IL Director of Regulatory Affairs/Quality Assurance Title 9 98 8
Date
Premarket Notification 510(k) Number
Coamatic® Heparin
ﺮ
Coamatic® Heparin 510(k)
Instrumentation Laboratory Company
Page 5 of 7 A CH-Werfen Company
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
3 1998 NOV
Ms. Carol Marble Requlatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re: K983178 Trade Name: Coamatic® Heparin Regulatory Class: II Product Code: KFF Dated: September 10, 1998 Received: September 11, 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 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 requlations affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
4
Page 2
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/dsma/dsmamain.html".
Sincerely yours,
Steven Dutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
راني
5
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Coamatic® Heparin
Indications for Use:
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Make
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983778
Prescription Use /
(Per 21 CFR 801.019)
OR Over-The-Counter Use