IL TEST AMYLASE

K974125 · Instrumentation Laboratory CO · JFJ · Dec 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974125
• Device Name: IL TEST AMYLASE
• Applicant: Instrumentation Laboratory CO
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.

Device Story

IL Test™ Amylase is an in vitro diagnostic reagent used with Instrumentation Laboratory clinical chemistry systems. It measures amylase levels in human serum, plasma, or urine samples using CNP-Maltotrioside methodology. The device is intended for use by laboratory professionals in clinical settings to assist in the diagnosis and management of pancreatitis. Results are provided to clinicians to inform clinical decision-making regarding pancreatic health.

Clinical Evidence

Bench testing only. Method comparison study evaluated 47 serum samples (r=1.000) and 71 urine samples (r=0.999) against the predicate. Within-run precision for serum showed CVs of 1.6% (mean 49 U/L) and 1.0% (mean 157 U/L). Within-run precision for urine showed CVs of 1.5% (mean 278 U/L) and 1.6% (mean 302 U/L).

Technological Characteristics

In vitro diagnostic reagent utilizing CNP-Maltotrioside methodology for quantitative enzymatic determination of amylase. Designed for use on Instrumentation Laboratory clinical chemistry systems. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for the quantitative determination of amylase in human serum, plasma, or urine to aid in the diagnosis and treatment of pancreatitis.

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).

Predicate Devices

• IL Test™ Amylase (K932467)
• IL Test™ Amylase (K943595)

Submission Summary (Full Text)

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K974125

# SECTION 3 IL Test™ Amylase - 510(k) SUMMARY (Summary of Safety and Effectiveness)

### Submitted by:

Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

## Contact Persons:

Carol Marble Phone: [phone] DEC 17 1997

Alternate: Betty Lane Phone: [phone]

### Summary Prepared:

October 31, 1997

#### Name of the device:

IL Test™ Amylase

## Classification name(s):

| 862.1070 | Amylase test systems | Class II |
|----------|------------------------|----------|
| 75CIJ | Saccharogenic, Amylase | |

## Identification of predicate device(s):

IL Test™ Amylase K932467 K943595 - Serum and Urine Claims Added

## Description of the device/intended use(s):

IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of Pancreatitis.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:

The new IL Test™ Amylase has the same intended use as the predicate II Test™ Amylase and is substantially equivalent in performance and safety and effectiveness.

#### Summary of Performance Data:

In a method comparison study evaluating 47 serum samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 1.000. In a separate study evaluating 71 urine samples, the correlation (r) of the new IL Test™ Amylase to the predicate IL Test™ Amylase was 0.999.

Within run precision for a serum sample accessed over multiple runs gave a CV of 1.6 % at a mean of 49 U/L and 1.0 % at a mean of 157 U/L. Within run precision for a urine sample accessed over multiple runs gave a CV of 1.5 % at a mean of 278 U/L and 1.6% at a mean of 302 U/L.

Page 1 of 1 IL Test™ Amylase 510(k) Section 3

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping, curved lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 17 1997

Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

Re : K974125 IL Test™ Amylase Regulatory Class: II Product Code: JFJ October 31, 1997 Dated: November 3, 1997 Received:

Dear Ms. Marble:

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 aqainst 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 requlations 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 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 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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Page 2

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 Sitman

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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## Indications for Use Statement

510(k) Number (if known): K974125

Device Name: IL Test™ Amylase

# Indications for Use:

ଫ୍ରି

il. Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| Prescription Use<br>(Per 21 CFR 801.019) | OR Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|

| Section 2 | IL Test™ Amylase 510(k) | Page 1 of 1 |
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