HEMOCHRON CITRATE APTT

K972831 · International Technidyne Corp. · GFO · Nov 20, 1997 · Hematology

Device Facts

• Record ID: K972831
• Device Name: HEMOCHRON CITRATE APTT
• Applicant: International Technidyne Corp.
• Product Code: GFO · Hematology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.

Device Story

The Hemochron Citrate APTT is a unitized microcoagulation test designed for use with the Hemochron Jr. instrument. It processes citrated whole blood samples to perform a quantitative, one-stage Activated Partial Thromboplastin Time (APTT) assay. The system is intended for point-of-care clinical settings and is operated by healthcare professionals. The device provides quantitative APTT results to assist clinicians in monitoring low-dose heparin anticoagulation therapy (up to 1.5 units/ml). By providing rapid, point-of-care coagulation data, the device facilitates timely clinical decision-making regarding heparin dosage adjustments, potentially improving patient management during anticoagulation therapy.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's intended use and technological characteristics as a unitized microcoagulation test.

Technological Characteristics

Unitized microcoagulation test cartridge for use with the Hemochron Jr. instrument. Employs a quantitative, one-stage APTT assay principle. Designed for citrated whole blood samples. Portable form factor for point-of-care use.

Indications for Use

Indicated for quantitative, one-stage Activated Partial Thromboplastin Time (APTT) testing in patients requiring monitoring of low-dose heparin anticoagulation (up to 1.5 units/ml). Uses citrated whole blood samples. For professional point-of-care use only; not for home use.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 2 0 1997

-.

Robert H. Matland Chief Compliance Officer International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820

K972831 Re : Hemochron Citrate APTT Requlatory Class: II Product Code: GFO, JPA Dated: October 3, 1997 Received: October 7, 1997

Dear Mr. Matland:

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 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 [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 qeneral 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 Ditman

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): K97283) Device Name: Hemochron Citrate APTT

Indications For Use:

.. .

The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended ---for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-O
Division of Cli
ces
510(k) Number K979831

Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_

(Optional Format 1-2-96)