(107 days)
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No
The document describes a biological reagent (plasma) used in a standard laboratory assay and contains no mention of AI or ML.
No.
The device is used for in vitro diagnostic testing to assess factor IX deficiencies, not for direct therapeutic intervention on a patient.
Yes
The device, CryoCheck Factor IX Deficient Plasma, is indicated for "assessing factor IX deficiencies in in vitro clot-based factor IX assays." This indicates its use in evaluating a patient's coagulation status to diagnose Factor IX deficiency, which is a diagnostic purpose.
No
The device is a biological product (human plasma) used in an in vitro diagnostic assay, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays". The term "in vitro" is a key indicator of an IVD.
- Mechanism of Action: The description explains how the device is used to diagnose a condition (factor IX deficiency) by testing a patient sample outside of the body (in vitro).
- Device Description: The device itself is a biological reagent (human plasma) used in a laboratory setting for diagnostic testing.
- Intended User/Care Setting: The intended use is in "in vitro clot-based factor IX assays," which are performed in a laboratory setting.
All of these points 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 the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor IX is a single chain protein with a molecular weight of 54,000 and is necessary for intrinsic coagulation. Factor IX deficiency (hemophilia B) is commonly diagnosed in vitro through the used of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor IX deficient plasma, the degree of correction of the APTT is proportional to the level of Factor IX in the patient plasma.
CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays using the activated partial thromboplast time.
Product codes
GJT
Device Description
CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sandy Morrison · Precision Biologicals 900 Windmill Road, #100 Dartmouth, Nova Scotia Canada B3B 1P7
JUL 1 8 1997
Re : K971226 CryoCheck Factor IX Deficient Plasma Regulatory Class: II Product Code: GJT May 29, 1997 Dated: Received: June 2, 1997
Dear Ms. Morrison:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਉ 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 regulatory 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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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 Litman
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 Factor IX Deficient Plasma
Indications For Use: Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor IX is a single chain protein with a molecular weight of 54,000 and is necessary for intrinsic coagulation. Factor IX deficiency (hemophilia B) is commonly diagnosed in vitro through the used of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor IX deficient plasma, the degree of correction of the APTT is proportional to the level of Factor IX in the patient plasma.
CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays using the activated partial thromboplastin time.
j
(Division Sign-Off)
Division of Clinical Laboratovices
510(k) Number K971226
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)