(11 days)
Not Found
No
The summary describes a standard in vitro diagnostic test based on a chromogenic substrate, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic test used for the quantitative determination of Protein C, which helps in the diagnosis of certain conditions, but it does not directly treat or prevent diseases.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma." This explicitly identifies it as a diagnostic device.
No
The device is an in vitro diagnostic test kit, which includes reagents and other physical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma..."
The "Device Description" section also states: "HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma..."
These statements clearly identify the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
Product codes
GGP
Device Description
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
SEP - 1 2006
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 781-861-4207 Fax No.:
Summary Prepared:
August 18, 2006
Name of the Device:
HemosIL Protein C
Regulatory Information:
| 864.7290 Factor Deficiency Test | Class II | |
|---|---|---|
| 81GGP | Test, Qualitative and Quantitative Factor Deficient |
Identification of Predicate Device(s):
K980875 HemosIL Protein C
Device Description:
ﺔ
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
Reason for Submission:
The Expected Values section of the HemosIL Protein C insert is being modified to reference a normal range from published literature, reinforcing the need for each laboratory to establish its own normal [reference] range due to the many variables which may affect results.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Protein C with the modified Expected Values section in the product insert is not materially different from the FDA cleared device.
Summary of Expected Values Section to the Modified Product Insert:
Protein C activity levels in healthy individuals are approximately in the range of 70 - 140%. Protein C levels are low in neonates and increase to adult levels during adolescence.*
Due to many variables which may affect results, each laboratory should establish its own normal range.
- Kottke-Marchant K, Comp P. Laboratory Issues in Diagnosing Abnormalities of Protein C, Thrombomodulin, and * Endothelial Cell Protein C Receptor, Arch Pathol Lab med 2002; 126:1337-1348.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
EP - 1 2006
Re: K062430
Trade/Device Name: HemosIL Protein C Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: August 18, 2006 Received: August 21, 2006
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). 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.
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Page 2 –
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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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): K062430
Device Name: HemosIL Protein C
Indications for Use:
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062430