AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K972297 · Trace America, Inc. · JFJ · Jul 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972297
• Device Name: AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
• Applicant: Trace America, Inc.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Jul 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis. "This 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)". , CFR 862.1070

Device Story

TRACE Amylase - DST Reagent is an in vitro diagnostic test system; measures amylase enzyme activity in human serum and urine samples. Used in clinical laboratory settings by trained personnel. Provides quantitative results to assist clinicians in diagnosing and monitoring pancreatitis. Operates via chemical reaction principles typical of enzymatic assays; results interpreted by healthcare providers to inform clinical decision-making regarding pancreatic health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for quantitative enzymatic assay of amylase. Standard clinical laboratory chemistry reagent format. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro quantitative determination of amylase in human serum and 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).

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles a caduceus, with three figures or lines that appear to be abstract representations of people or a staff with intertwined snakes, a common symbol for health and medicine.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David Johnston Technical Director TRACE America, Inc. · 7260 North West 58th Street Miami, Florida 33166

JUL 17 1997

Re : K972297 Amylase-Incorporating Dynamic Stabilization Technoloqy Regulatory Class: II Product Code: JFJ Dated: June 6, 1997 Received: June 19, 1997

Dear Mr. Johnston:

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 Regulations, Title 21, Parts 800 to 895. ਸ 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 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 .

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

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 diaqnostic 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 Gutman

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

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

Page __ 1__ of __ 1___

510(k) Number (if known): (to be assigned) Device Name: TRACE Amylase - DST Reagent

Indications for Use:

Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.

"This 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)". , CFR 862.1070

(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 | K972297 |

| Prescription Use | <div style="text-align: center;">✓</div> |
|----------------------|------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)