SPECTROLYSE HEPARIN (ANTI-IIA)

K972209 · Medical Diagnostic Technologies, Inc. · KFF · Aug 12, 1997 · Hematology

Device Facts

• Record ID: K972209
• Device Name: SPECTROLYSE HEPARIN (ANTI-IIA)
• Applicant: Medical Diagnostic Technologies, Inc.
• Product Code: KFF · Hematology
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Indications for Use

Spectrolyse® Heparin (anti-IIa) is intended for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma by anti-fl activity.

Device Story

Spectrolyse® Heparin (anti-IIa) is an in vitro diagnostic assay used for the quantitative measurement of therapeutic heparin levels, including both standard and low molecular weight heparin, in human plasma. The device utilizes an anti-IIa activity-based method to determine heparin concentration. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides a quantitative measurement of heparin, which assists clinicians in monitoring therapeutic heparin levels to guide patient anticoagulation management and ensure therapeutic efficacy while minimizing bleeding risks.

Clinical Evidence

No clinical data provided; the submission relies on substantial equivalence to existing legally marketed devices for the same intended use.

Technological Characteristics

In vitro diagnostic assay for quantitative determination of heparin in human plasma via anti-IIa activity. The device functions as a biochemical reagent system for laboratory use.

Indications for Use

Indicated for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma for patients requiring heparin therapy monitoring.

Regulatory Classification

Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

Submission Summary (Full Text)

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AUG 1 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael D. Bick, Ph.D. · Chief Executive Officer Biopool International 6025 Nicolle Street Ventura, CA 93003

K972209 Re : Spectrolyse® Heparin (anti-IIa) Regulatory Class: II Product Code: KFFF Dated: June 10, 1997 Received: June 11, 1997

Dear Dr. Bick:

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 qeneral 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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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 requlation (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 Sitman

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):

Device Name:

Spectrolyse® Heparin (anti-IIa)

Indications for Use:

Spectrolyse® Heparin (anti-IIa) is intended for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma by anti-fl activity.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number 972209

Division of Clinical Lab. Devices
510(k) Number k-972209

**Prescription Use**
(Per 21 CFR 801.109) ✓

Over-The-Counter Use ‫(

(Optional Format 1-2-96)