(165 days)
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Not Found
No
The summary describes a standard ELISA kit, which is a biochemical assay, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
This device is an in vitro diagnostic kit used for screening patient samples, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "intended to be used as an in vitro diagnostic kit" to assist in screening patient samples for heparin-associated antibodies.
No
The device is an in vitro diagnostic kit, which is a physical product used in a laboratory setting, not a software-only medical device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "INDICATIONS FOR USE" explicitly states that the product is "intended to be used as an in vitro diagnostic kit".
- Device Description: While the description is brief, it describes an "enzyme-linked immunosorbent assay (ELISA)", which is a common technique used in in vitro diagnostics.
- Intended User / Care Setting: The intended users are "hematology, coagulation or other pathology laboratories", which are typical settings for performing in vitro diagnostic tests.
The core purpose of the device, as described, is to analyze patient samples outside of the body to assist in diagnosing a medical condition (heparin-induced thrombocytopenia or thrombosis), which is the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
INDICATIONS FOR USE OF GTI-PF4 ELISA FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST PLATELET FACTOR 4 (PF4):POLYVINYL SULFONATE (PVS) COMPLEX
GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis.
Product codes
LCO
Device Description
GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hematology, coagulation or other pathology laboratories
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)
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
§ 864.7695 Platelet factor 4 radioimmunoassay.
(a)
Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human figures in profile, arranged in a row. The figures are connected and appear to be moving forward. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figures.
MAR - 9 1999
Mr. Michael Moghaddam Director, Research and Development Genetic Testing Institute 150 North Patrick Boulevard Brookfield, Wisconsin 53045
Re: K983379 Trade Name: GTI-PF4 ELISA Regulatory Class: II Product Code: LCO Dated: December 28, 1998 Received: December 29, 1998
Dear Mr. Moghaddam:
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 Regulations, 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 (OS) 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 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1
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 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 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
2
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| 510(k) Number (if known): | K 983379 |
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Device Name:
Indications For Use:
INDICATIONS FOR USE OF GTI-PF4 ELISA FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST PLATELET FACTOR 4 (PF4):POLYVINYL SULFONATE (PVS) COMPLEX
GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis.
Peter E. Merlin
5 111 (Division Siur ﻧﺪ ﺗﻪ ﺗﺎﺭﻳﺨﺎﻃﺎ ﺍﻟﻤ Divisio: 510(k) Nuilder
(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)