AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)

K023396 · Pointe Scientific, Inc., · CIJ · Dec 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023396
• Device Name: AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
• Applicant: Pointe Scientific, Inc.,
• Product Code: CIJ · Clinical Chemistry
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.

Device Story

Amylase EPS-G7 (Liquid) Reagent Set is an in vitro diagnostic reagent for quantitative measurement of amylase in human serum. Used in clinical laboratory settings by qualified technologists. Principle of operation involves enzymatic reaction to determine amylase levels, aiding in diagnosis and treatment of pancreatic diseases. Output is a quantitative value representing serum amylase concentration. Device facilitates clinical decision-making regarding pancreatic health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid reagent set for in vitro diagnostic use; enzymatic assay for amylase quantification in human serum.

Indications for Use

Indicated for the quantitative determination of amylase in human serum in a diagnostic laboratory setting by qualified technologists for the diagnosis and treatment of pancreatic diseases.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 2098 Gaither Road, Rockville MD 20850. The text is black and the background is white. The text is left-aligned.

Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146

Re:

k023396 Trade/Device Name: Amylase EPS-G7 (Liquid) Reagent Set Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: Class II Product Code: CIJ Dated: December 3, 2002 Received: December 4, 2002

Dear Mr. Jamison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

## Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K023396 510 (k) Number (if known):

Device Name: Amylase EPS-G7 (Liquid) Reagent se

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.

Division Sion-Off vices Division of 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Counter Use (Per 21 CFR 801.109)

OR

Over the

(Optional Format 1-2-96)