AMYLASE

K980013 · Ac Biochemicals, Inc. · CIJ · Feb 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980013
• Device Name: AMYLASE
• Applicant: Ac Biochemicals, Inc.
• Product Code: CIJ · Clinical Chemistry
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The Amylase Reagent is to be used in the assessment of pancreatitis.

Device Story

Amylase Reagent is an in vitro diagnostic test used for the assessment of pancreatitis. The device is intended for professional use in a clinical laboratory setting. It functions by measuring amylase levels in patient samples to assist clinicians in diagnosing or monitoring pancreatic conditions. The output is a quantitative or qualitative result provided to the healthcare provider, which informs clinical decision-making regarding patient management and treatment of pancreatitis.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) notification.

Technological Characteristics

In vitro diagnostic reagent for amylase measurement. Class II device, product code CIJ. Operates via chemical assay principles for clinical laboratory analysis.

Indications for Use

Indicated for the assessment of pancreatitis in patients.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Charles C. Allain, Ph.D. President/CEO AC Biomedicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614

K980013 Re : Amylase Regulatory Class: II Product Code: CIJ December 22,1997 Dated: Received: January 2, 1998

Dear Dr. Allain:

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 Requlations, Title 21, Parts 800 to 895. ਰੇ 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 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 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/dsmamain.html".

Sincerely yours,
Steven Litman

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: Amylase

Indications For Use:

The Amylase Reagent is to be used in the assessment of pancreatitis.

(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number _k980013

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801:109)

Over-The-Counter Use