(144 days)
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Not Found
No
The summary describes a laboratory test kit using an immuno-turbidimetric assay, which is a standard biochemical method and does not mention any AI or ML components.
No
This device is a test kit designed for the "squantitation of plasminogen in in human plasma," which indicates it is used for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that "Measurement of plasminogen is helpful in the diagnosis of these conditions," indicating its use in diagnosing medical conditions.
No
The device description clearly states it is a "Test Kit," which implies physical components (reagents, etc.) are involved in the assay, not just software. The intended use also describes a laboratory-based immuno-turbidimetric assay, which is a wet chemistry process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is used for the "quantitation of plasminogen in human plasma". This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide information about a physiological state (plasminogen levels).
- Clinical Importance: The intended use also highlights the clinical importance of measuring plasminogen levels for the diagnosis of conditions like liver disease, DIC, and severe nephrosis. This directly relates the test results to providing information for medical diagnosis.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.
Product codes
GGP, DDX
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 20 1997
Mary Rees Official Correspondent Kamiya Technology Services 374 Goodhill Road Weston, Connecticut 06883
K971985 Re: N-Assay TIA Plasminogen Test Kit Requlatory Class: II Product Code: GGP, DDX September 8, 1997 Dated: September 17, 1997 Received:
Dear Ms. Rees:
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 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. A 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 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 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 described in your sia\n ppivalence 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 Gutman
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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K971985 510(k) Number (if known): ·
N-Assay TIA Plasminogen Test Kit Device Name:
Indications For Use:
The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-Decreased levels of plasminogen are of turbidimetric assay. Low levels of plasminogen are usually clinical importance. due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.
(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 vices
510(k) Number. 9785