AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10

K974053 · Diagnostic Chemicals , Ltd. · JFJ · Dec 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974053
• Device Name: AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

For the quantitative determination of a-amylase in serum. For IN VITRO diagnostic use.

Device Story

The a-Amylase-SL Assay is an in vitro diagnostic reagent used for the quantitative measurement of alpha-amylase enzyme levels in human serum. It is intended for use by clinical laboratory professionals. The assay functions by measuring the hydrolytic activity of alpha-amylase, which breaks down starch and glycogen into maltose. Elevated serum levels of this enzyme serve as a clinical indicator for conditions affecting the digestive tract, specifically the parotid glands and the pancreas. Healthcare providers utilize the quantitative results to aid in the diagnosis and monitoring of pancreatic diseases, particularly those involving ductal obstruction. The device is designed for professional laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and performance characteristics as an in vitro diagnostic assay for serum alpha-amylase.

Technological Characteristics

In vitro diagnostic reagent assay for alpha-amylase (1,4-a-D-Glucan glucanohydrolase, EC 3.2.1.1). The assay measures enzymatic hydrolysis of starch/glycogen substrates. Class II device, product code JFJ.

Indications for Use

Indicated for the quantitative determination of a-amylase in serum for in vitro diagnostic use to assist in the diagnosis of diseases affecting the parotid glands and pancreas, such as pancreatic duct obstruction.

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

DEC - 8 1997

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charolettetown, PE Canada C1E, 1B0

Re : K974053 a-Amylase-SL Assay Requlatory Class: II Product Code: JFJ October 24, 1997 Dated: October 27, 1997 Received:

Dear Ms. Callbeck:

requlations.

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 regulations 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 General regulation (21 CFR Part 820) and that, Devices: 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

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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 requlation (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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K974053/01

510(k) Number (if known):

Device Name: a-Amylase-SL Assay

## Indications For Use:

For the quantitative determination of a-amylase in serum. For IN VITRO diagnostic use.

1974053

a-Amylase (1,4-a-D-Glucan glucanohydrolase, EC3.2.1.1) is an enzyme of the digestive tract. It hydrolyzes dietary starch and glycogen to form maltose by splitting their chains at alternate hemiacetal linkages. The enzyme is normally secreted into the digestive tract from the parotid glands and the pancreas. In diseases affecting these glands, and particularly when the pancreatic duct is obstructed, the amount of enzyme in serum is increased.1

Burtis, Carl A. and Ashwood, Edward, R. (Ed.), Tietz, Textbook of Clinical Chemistry, W.B. Saunders Co. Pennsylvania, 854-856 (1994).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k974037

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OR

Over-The-Counter Use _

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