(149 days)
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No
The document describes a validation set for prothrombin time testing and makes no mention of AI or ML technologies.
No
The device is described as a "CryoCheck INR Validation Set" which is used to monitor the accuracy and control of oral anticoagulant therapy by validating prothrombin time systems. It is not used to treat, diagnose, or prevent any condition.
No
Explanation: The device, CryoCheck INR Validation Set, is a set of well-characterized warfarinized plasmas used for validating the accuracy and control of PT systems in monitoring oral anticoagulant therapy, not for directly diagnosing a patient's condition.
No
The device description is not provided, but the intended use describes a "CryoCheck INR Validation Set" which is a set of "well characterized warfarinized plasmas". This indicates the device includes physical components (plasma samples) and is not solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems." This involves testing patient samples (warfarinized plasmas) in vitro (outside the body) to assess the performance of other diagnostic systems.
- Nature of the Device: The device is described as a "set of well characterized warfarinized plasmas with system specific INR assigned ranges." These are biological materials used in a laboratory setting to evaluate the performance of diagnostic tests.
- Context of Use: The device is used in the context of "laboratory monitoring of the PT test," which is a standard in vitro diagnostic procedure.
The description aligns perfectly 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
The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR'S!
With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's.
CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges.
CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial. thromboplastins.
Product codes
GGN
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 864.5425 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.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Stephen L. Duff Precision Biologicals 900 Windmill Road, #100 Dartmouth, Nova Scotia Canada B3B 1P7
AUG 2 9 1997
K971219 Re: Cryo Check™ INR Validation Set 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 The general controls provisions of the Act 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 affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 requlations.
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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 requlation (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
2
902 468 642" => SENT BY: PRECISION BIOLOGICAL; 8-25-97 12:44;
Page /
510(k) Number (if known): not yet issued K * + 51712/9
Device Name: CryoCheck INR Validation Set
Indications For Use: The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR'S!
With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's.
CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges.
CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial. thromboplastins.
(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) |
| ------------------------------------------ | ----------------------------------------- | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Clinical Laboratory Devices,
| 510(k) Number | 5971219 |
|---|---|
| --------------- | --------- |