PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

K971825 · Randox Laboratories, Ltd. · JFJ · Jul 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971825
• Device Name: PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
• Applicant: Randox Laboratories, Ltd.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of creatic disorders when compared to total amylase assessment. This test kit must be d by suitable qualified laboratory personnel under appropriate laboratory conditions.

Device Story

In vitro diagnostic reagent kit; utilizes ethylidene-blocked pNPG substrate for colorimetric measurement of pancreatic α-amylase activity in serum or urine. Measures pancreatic isoamylase specifically; provides higher clinical specificity for pancreatic disorders than total amylase assays. Intended for use by qualified laboratory personnel in clinical laboratory environments. Output is a quantitative concentration value used by clinicians to assess pancreatic function and diagnose pancreatic disease.

Technological Characteristics

In vitro diagnostic reagent; colorimetric enzymatic assay using ethylidene-blocked pNPG substrate. Quantitative measurement of pancreatic α-amylase activity. Form factor: reagent kit for laboratory use.

Indications for Use

Indicated for the quantitative determination of pancreatic α-amylase in human serum and urine samples to aid in the diagnosis of pancreatic disorders. For use by qualified laboratory personnel in a clinical laboratory setting.

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

Dr. P. Armstrong Randox Laboratories Ltd. Ardmore, · Diamond Road Crumlin Co, Antrim United Kingdom, BT29 4QY

K971825 Re : Pancreatic α - amylase Requlatory Class: II Product Code: JFJ Dated: July 3, 1997 Received: July 11, 1997

Dear Dr. Armstrong:

JUL 2 4 1997

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, Druq, 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. 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 requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 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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(k) Number (if known) K971825

PANCREATIC a - AMYLASE ce Name __

ETHYLIDENE BLOCKED - pNPG- ENZYME COLORIMETRIC TEST

## cations For Use :

Randox Laboratories Limited Pancreatic α - Amylase (Ethylidene Blocked - pNPGyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative ermination of pancreatic α - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of creatic disorders when compared to total amylase assessment. This test kit must be d by suitable qualified laboratory personnel under appropriate laboratory conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

scription Use r 21 CFR 801.109)

OR

Over-The-Counter Use (Optional format 1-2-96)

(Division Sign-Off

Division Clinet Lahjatory des Ca

510(k) Numb. 977825