N-ASSAY TIA APO A1 TEST KIT

K964292 · Crestat Diagnostics, Inc. · DER · Aug 1, 1997 · Immunology

Device Facts

• Record ID: K964292
• Device Name: N-ASSAY TIA APO A1 TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: DER · Immunology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5580
• Device Class: Class 2

Intended Use

The N-Assay TIA Apoprotein A-1 Test Kit is intended to be used for the quantitative determination of human apoprotein A-1 in human serum by immunoturbidimetric assay. The measurement of apoprotein A-1 is useful in the diagnosis of atherosclerosis.

Device Story

The N-Assay TIA Apoprotein A-1 Test Kit is an in vitro diagnostic reagent system used for the quantitative measurement of apoprotein A-1 in human serum. The device utilizes an immunoturbidimetric assay principle, where the presence of apoprotein A-1 in the sample is measured via turbidity changes. The test is performed in a clinical laboratory setting by trained laboratory personnel. The resulting quantitative values are used by clinicians to assess apoprotein A-1 levels, which serves as a diagnostic aid for atherosclerosis. The device provides objective data to support clinical decision-making regarding cardiovascular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay for quantitative determination of apoprotein A-1 in human serum.

Indications for Use

Indicated for the quantitative determination of human apoprotein A-1 in human serum to aid in the diagnosis of atherosclerosis.

Regulatory Classification

Identification

An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

CRESTAT DIAGNOSTICS, INC.
c/o Ms. Mary Rees
Official Correspondent
KAMIYA TECHNOLOGY SERVICES
374 Goodhill Road
Weston, CT 06883

AUG - 1 1997

Re: K964292/S002
Trade Name: N-Assay® TIA Apolipoprotein A-1 Test Kit
Regulatory Class: II
Product Code: DER
Dated: May 04, 1997
Received: May 09, 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 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 requirement, 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

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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Page 1 of 1

10(k) Number (if known): K964292

Device Name: N-Assay TIA Apoprotein A-1

Indications For Use:

The N-Assay TIA Apoprotein A-1 Test Kit is intended to be used for the quantitative determination of human apoprotein A-1 in human serum by immunoturbidimetric assay. The measurement of apoprotein A-1 is useful in the diagnosis of atherosclerosis.


(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K964292

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

21 CFR 801 1051

OK

Over The Counter Use

(Optional Format 1-2-96)

K-331/10/91