N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT

K965100 · Crestat Diagnostics, Inc. · DEM · Jul 14, 1997 · Immunology

Device Facts

• Record ID: K965100
• Device Name: N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: DEM · Immunology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The N-Assay TIA Alpha-1-Antitrypsin Test Kit is intended for the quantification of human alpha-1-antitrypsin in human serum by immunoturbidimetric assay. The measurement of alpha-1-antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Device Story

The N-Assay TIA Alpha-1-Antitrypsin Test Kit is an in vitro diagnostic reagent system used for the quantitative determination of alpha-1-antitrypsin levels in human serum. The device utilizes an immunoturbidimetric assay principle, where the reaction between alpha-1-antitrypsin in the patient sample and specific antibodies results in turbidity proportional to the analyte concentration. This turbidity is measured to provide a quantitative result. The test is performed in a clinical laboratory setting by trained laboratory personnel. The resulting measurements assist clinicians in diagnosing liver cirrhosis and identifying alpha-1-antitrypsin deficiency related to pulmonary emphysema, thereby guiding appropriate clinical management and treatment strategies for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay for quantitative measurement of alpha-1-antitrypsin in human serum. Reagent-based diagnostic test kit.

Indications for Use

Indicated for the quantitative measurement of alpha-1-antitrypsin in human serum to aid in the diagnosis of liver cirrhosis (juvenile and adult) and pulmonary emphysema associated with alpha-1-antitrypsin deficiency.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Crestat Diagnostics, Inc.
c/o Ms. Mary Rees
Official Correspondent
374 Goodhill Road
Weston, Connecticut 06883

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUL 14 1997

Re: K965100/S2
Trade Name: N-Assay TIA Alpha-1-Antitrypsin Test Kit
Regulatory Class: II
Product Code: DEM
Dated: June 14, 1997
Received: June 17, 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 ___ of ___

510(k) Number (if known): K965100

Device Name: N-Assay TIA Alpha-1-Antitrypsin Test Kit

Indications For Use:

The N-Assay TIA Alpha-1-Antitrypsin Test Kit is intended for the quantification of human alpha-1-antitrypsin in human serum by immunoturbidimetric assay. The measurement of alpha-1-antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)