N-ASSAY TIA ANTITHROMBIN III TEST KIT

K972257 · Crestat Diagnostics, Inc. · DDQ · Oct 20, 1997 · Hematology

Device Facts

• Record ID: K972257
• Device Name: N-ASSAY TIA ANTITHROMBIN III TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: DDQ · Hematology
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.

Device Story

N-Assay TIA Antithrombin III Test Kit is an in vitro diagnostic assay for quantifying human antithrombin III in human plasma. Used in clinical laboratory settings by trained personnel. The device utilizes turbidimetric immunoassay (TIA) technology to measure antithrombin III levels. Results are provided to clinicians to assist in identifying patients at risk for thromboembolism (levels <60% of normal) and to monitor the efficacy of heparin therapy. The device provides quantitative data to support clinical decision-making regarding anticoagulation management and thrombotic risk assessment.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Turbidimetric immunoassay (TIA) for the quantification of antithrombin III in human plasma. In vitro diagnostic test kit.

Indications for Use

Indicated for the quantification of human antithrombin III in human plasma to assess risk of thromboembolism (levels <60% of normal) and to monitor heparin therapy.

Regulatory Classification

Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mary Rees . Official Correspondent Kamiya Technology Services 374 Goodhill Road 06883 Weston, Connecticut

OCT 20 1997

Re: K972257 N-Assay TIA Antithrombin III Test Kit Regulatory Class: II Product Code: JBQ, DDQ Dated: September 12, 1997 Received: September 17, 1997

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 regulations 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 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 [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/dsmamain.html".

Sincerely yours,
Steven Bitman

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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> 10(k) Number (if known):

N-ASSAY TIA ANTITHROMBIN III Device Name:

Indications For Use:

.:

The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism.

The assay of plasma AT-TII is also helpful in monitoring heparin therapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laborator vices
510(k) Number.

. I

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Format 1-2-96)