AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K980030 · Trace America, Inc. · CIT · Jan 30, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980030
• Device Name: AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
• Applicant: Trace America, Inc.
• Product Code: CIT · Clinical Chemistry
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers. "Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100

Device Story

AST (GOT) Liquid Stable 2 Vial Reagent is an in vitro diagnostic chemical reagent used for the quantitative measurement of aspartate aminotransferase activity in human serum. The device is intended for use on automated chemistry analyzers in clinical laboratory settings. By reacting with serum samples, the reagent enables the quantification of AST levels, which clinicians use to diagnose and monitor liver and heart conditions. The device provides objective biochemical data to support clinical decision-making regarding patient pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid stable 2-vial chemical reagent system for automated chemistry analyzers. Principle of operation is based on standard enzymatic kinetic assay for AST (GOT) activity measurement.

Indications for Use

Indicated for the in vitro quantitative determination of AST (GOT) activity in human serum for the diagnosis and treatment of liver and heart disease.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 30 1956

David Johnston . TAI Technical Director TRACE America, Inc. 7260 Northwest 58th Street Miami, Florida 33166

K980030 Re : AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST Requlatory Class: II Product Code: CIT Dated: December 23, 1997 Received: January 5, 1998

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, Druq, 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 requiations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good-Manufacturing Practice requirements; as set --forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 -requlations.

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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 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 Bitman

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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Page ___1___ of

510(k) Number (if known): Device Name: _ AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT_ Indications for Use:

Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.

"Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

for a Montgomery

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