(64 days)
Not Found
Not Found
No
The summary describes a clotting assay for determining resistance to activated protein C, which is a standard laboratory test and does not mention any AI or ML components.
No
The device is described as being for "determination of resistance to activated protein C in human plasma using a clotting assay," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is intended for "determination of resistance to activated protein C in human plasma using a clotting assay," which is a diagnostic purpose to identify a hereditary defect (aPC Resistance) related to thrombophilia.
No
The description clearly states the device is a "clotting assay" which implies a physical test involving plasma, not a software-only device.
Yes, based on the provided information, the Bioclot® aPC Sensitivity device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "determination of resistance to activated protein C in human plasma using a clotting assay." This involves testing a sample taken from the human body (plasma) outside of the body (in vitro) to provide diagnostic information about a medical condition (resistance to activated protein C, which is linked to thrombophilia).
This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.
Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.
Product codes
GGP
Device Description
Not Found
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)
Not Found
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle's head or a stylized human profile.
6 1999 JAN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael D. Bick, Ph.D. Chief Executive Officer Biopool International, Inc. 6025 Nicolle Street Ventura, California 93003
Re: K983898 Bioclot® aPC Sensitivity Kit Trade Name: Requlatory Class: II Product Code: GGP Dated: October 30, 1998 November 3, 1998 Received:
Dear Dr. Bick:
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 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 Requlation (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 requlatory 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.
1
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 Butman
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
2
Page 1 of 1
510(k) Number (if known):
Device Name:
Bioclot® aPC Sensitivity
Indications for Use:
Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.
Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tetu E. Mafeni
ision Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)