N-ASSAY TIA PLASMINOGEN TEST KIT

K971985 · Crestat Diagnostics, Inc. · GGP · Oct 20, 1997 · Hematology

Device Facts

• Record ID: K971985
• Device Name: N-ASSAY TIA PLASMINOGEN TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: GGP · Hematology
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-Decreased levels of plasminogen are of turbidimetric assay. Low levels of plasminogen are usually clinical importance. due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.

Device Story

In vitro diagnostic test kit for quantitative measurement of plasminogen in human plasma; utilizes immuno-turbidimetric assay principle. Used in clinical laboratory settings by trained personnel. Provides quantitative results to clinicians to aid in diagnosing liver disease, DIC, and severe nephrosis. Helps assess patient coagulation status and synthetic liver function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immuno-turbidimetric assay for plasminogen quantification in human plasma. In vitro diagnostic reagent kit.

Indications for Use

Indicated for the quantitative measurement of plasminogen in human plasma to assist in the diagnosis of conditions associated with low plasminogen levels, including liver disease, disseminated intravascular coagulation (DIC), and severe nephrosis.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 20 1997

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

K971985 Re: N-Assay TIA Plasminogen Test Kit Requlatory Class: II Product Code: GGP, DDX September 8, 1997 Dated: September 17, 1997 Received:

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 requlations 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 requlation (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 described in your sia\n ppivalence 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 Gutman

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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K971985 510(k) Number (if known): ·

N-Assay TIA Plasminogen Test Kit Device Name:

Indications For Use:

The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-Decreased levels of plasminogen are of turbidimetric assay. Low levels of plasminogen are usually clinical importance. due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.

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

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)

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number. 9785