GTI-PF4 ELISA

K983379 · Genetic Testing Institute · LCO · Mar 9, 1999 · Hematology

Device Facts

• Record ID: K983379
• Device Name: GTI-PF4 ELISA
• Applicant: Genetic Testing Institute
• Product Code: LCO · Hematology
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7695
• Device Class: Class 2

Indications for Use

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.

Device Story

GTI-PF4 ELISA is a solid-phase enzyme-linked immunosorbent assay (ELISA) kit. It detects antibodies directed against the Platelet Factor 4 (PF4):Polyvinyl Sulfonate (PVS) complex in patient serum or plasma samples. Used in clinical laboratory settings (hematology, coagulation, pathology) by trained laboratory personnel. The assay provides qualitative or semi-quantitative results indicating the presence of heparin-associated antibodies. These results assist clinicians in the diagnosis and management of heparin-induced thrombocytopenia (HIT) or thrombosis. The device aids in clinical decision-making regarding heparin therapy continuation or cessation.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Solid-phase enzyme-linked immunosorbent assay (ELISA) kit. Utilizes PF4:PVS complex as the antigen for antibody detection. Designed for use in clinical laboratory environments. Manual or automated plate-based processing.

Indications for Use

Indicated for use in hematology, coagulation, or pathology laboratories to screen patient samples for heparin-associated antibodies in patients suspected of having heparin-induced thrombocytopenia or thrombosis.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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

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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)