(139 days)
Not Found
Not Found
No
The document describes a plasma control for a clot-based assay and does not mention any AI or ML components.
No
Explanation: The device is a positive control for laboratory assessment of activated protein C resistance, not a device used for treating a disease.
No
Explanation: The device is described as a "positive control" for assessing activated protein C resistance. This indicates it is a reference material used in a diagnostic test, rather than a diagnostic device itself.
No
The device description and intended use clearly describe a plasma product used as a control in a laboratory test, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma." This describes a test performed in vitro (outside the body) on a human specimen (citrated human plasma) to provide information about a medical condition (activated protein C resistance, a risk factor for venous thrombosis).
- Device Description: The device is a "CryoCheck APC Resistant Plasma," which is a reagent used in a laboratory test.
These characteristics align 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.
N/A
Intended Use / Indications for Use
Activated protein C (APC) is a serine protease with potent anticoagulant properties. During normal hemostasis, APC hinders clot formation through a mechanism of proteolytic inactivation of factors Va and VIIIa. Recently, a genetic single point mutation in the APC binding domain of the factor V gene, replacing Arg506 with Gln, was demonstrated to be both inherited and associated with familial thrombophilia. The resulting resistance of factor Va to activated protein C (APCR), often referred to as the factor Veiden mutation, is now recognized as a commonly inherited risk factor for venous thrombosis.
CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.
Product codes
GGN
Device Description
CryoCheck APC Resistant Plasma is a positive control for the clot-based assessment of activated protein C resistance in citrated human plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Applicable - In vitro diagnostic device.
Indicated Patient Age Range
Not Applicable - In vitro diagnostic device using human plasma.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 9 1997
Mr. Stephen L. Duff New Business Development Precision Bioloqicals 900 Windmill Road, #100 Dartmouth, Nova Scotia . Canada B3B 1P7
K971222/S1 Re: Trade Name: CRYOV CHECK™ APC RESISTANT PLASMA Requlatory Class: II Product Code: GGN Dated: June 16, 1997 Received: June 19, 1997
Dear Mr. Duff:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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.
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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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
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Page / of /
510(k) Number (if known): not yet issued
Device Name: CryoCheck APC Resistant Plasma
Indications For Use: Activated protein C (APC) is a serine protease with potent anticoagulant properties. During normal hemostasis, APC hinders clot formation through a mechanism of proteolytic inactivation of factors Va and VIIIa. Recently, a genetic single point mutation in the APC binding domain of the factor V gene, replacing Arg506 with Gln, was demonstrated to be both inherited and associated with familial thrombophilia. The resulting resistance of factor Va to activated protein C (APCR), often referred to as the factor Veiden mutation, is now recognized as a commonly inherited risk factor for venous thrombosis.
CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.
Christopher A. Montgomery
Division of Clinical Laboratory Devices 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| -------------------------------------------------------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
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