SIMPLIFY D-DIMER, MODEL DCGK1

K993276 · Agen Biomedical , Ltd. · GHH · Dec 14, 1999 · Hematology

Device Facts

• Record ID: K993276
• Device Name: SIMPLIFY D-DIMER, MODEL DCGK1
• Applicant: Agen Biomedical , Ltd.
• Product Code: GHH · Hematology
• Decision Date: Dec 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.

Device Story

Simplify D-dimer is a rapid immunochromatographic assay for qualitative detection of fibrin degradation products (D-dimer) in human whole blood or plasma. Used as an aid in diagnosing DIC, DVT, and pulmonary embolism. Operates via lateral flow immunoassay principle; sample applied to test device; presence of D-dimer indicated by visual color change. Intended for professional clinical use. Results assist clinicians in evaluating patients suspected of thrombotic conditions, facilitating timely diagnostic and therapeutic decision-making.

Clinical Evidence

No clinical data provided in the document; 510(k) clearance based on substantial equivalence determination.

Technological Characteristics

Rapid immunochromatography test; lateral flow assay format; qualitative visual readout; utilizes human whole blood or plasma samples.

Indications for Use

Indicated for qualitative detection of D-dimer in human whole blood and plasma to aid in the diagnosis of disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE).

Submission Summary (Full Text)

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## DEC I 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Russell Richards Director, Regulatory Affairs and International Market Support Agen Biomedical Limited 11 Durbell Street, P.O. Box 391 Acacia Ridge, Brisbane Queensland 4110 AUSTRALIA

Re: K993276 Trade Name: Simplify™ D-dimer Regulatory Class: II Product Code: GHH Dated: September 23, 1999 Received: September 30, 1999

Dear Mr. Richards:

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 (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 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 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): | K993276 |
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SIMPLIFY D-DIMER Device Name: _

Indications For Use:

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Makin

(Division Sign-Off) Division of Clinical Laboratory Devices KG327 510(k) Number

Prescription Use रे (Pcr 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)