INFINITY AST REAGENT (PROCEDURE NO. 51)

K980666 · Sigma Diagnostics, Inc. · CIT · Mar 20, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980666
• Device Name: INFINITY AST REAGENT (PROCEDURE NO. 51)
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CIT · Clinical Chemistry
• Decision Date: Mar 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum on both automated and manual systems.

Device Story

The Sigma Diagnostics INFINITY™ AST Reagent is an in vitro diagnostic assay used to measure AST enzyme activity in human serum. The device utilizes an enzymatic kinetic method based on IFCC recommendations. AST in the sample catalyzes the transfer of an amino group from L-aspartate to 2-oxoglutarate, producing oxaloacetate and L-glutamate. Oxaloacetate is then reduced to L-malate by malate dehydrogenase (MDH) in the presence of NADH, which is oxidized to NAD. The assay includes lactate dehydrogenase (LDH) to reduce endogenous pyruvate, preventing interference. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm. The device is intended for use in clinical laboratory settings on automated or manual systems by trained laboratory personnel. Results assist clinicians in diagnosing and monitoring conditions such as myocardial infarction, viral hepatitis, liver necrosis, cirrhosis, and muscular dystrophy.

Clinical Evidence

No clinical data provided; the device relies on established enzymatic assay principles (IFCC method) and substantial equivalence to a previously cleared predicate device.

Technological Characteristics

In vitro diagnostic reagent kit. Principle: Kinetic UV assay measuring NADH oxidation at 340 nm. Components: L-aspartate, 2-oxoglutarate, NADH, Malate dehydrogenase (MDH), and Lactate dehydrogenase (LDH). Form factor: Liquid reagent. Connectivity: Compatible with standard automated and manual clinical chemistry analyzers.

Indications for Use

Indicated for the in vitro quantitative measurement of aspartate aminotransferase (AST) activity in human serum to aid in the diagnosis and treatment of liver and heart diseases.

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.

Predicate Devices

• TRACE Scientific AST (DST) Reagent Kit (K961114)

Submission Summary (Full Text)

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K980666

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFINITY™ AST Reagent, Procedure 51-UV

Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum on both automated and manual systems.

AST is widely distributed with high concentrations in the heart, liver, skeletal muscle, kidney and erythrocytes. Damage or disease to any of these tissues such as myocardial infarction, viral hepatitis, liver necrosis, cirrhosis and muscular dystrophy may result in raised serum levels of AST.

The Sigma Diagnostics INFINITY AST Reagent is based on the recommendations of the IFCC.2 The series of reactions involved in the assay system is as follows:

- AST present in the sample catalyzes the transfer of the amino group from L-aspartate to 2-1 . oxoglutarate forming oxaloacetate and L-glutamate.
- Oxaloacetate in the presence of NADH and Malate dehydrogenase (MDH), is reduced to 2. L-malate. In this reaction NADH is oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
- Addition of Lactate dehydrogenase (LDH) to the reagent is necessary to achieve rapid and 3. complete reduction of endogenous pyruvate so that it does not interfere with the assay.

The Sigma Diagnostics INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114.

#### References

- Zilva JF, Pannall PR. "Plasma Enzymes in Diagnosis" in Clinical Chemistry in Diagnosis 1. and Treatment. Lloyd-Luke London. 1979:Chap 17:338-9.
- IFCC Method for L-Aspartate aminotransferase. J Clin Chem Clin Biochem 1986; 2. 24:497-510.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 20 1998

William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103

Re : K980666 INFINITY™ AST Reagent (Procedure No. 51) Regulatory Class: II Product Code: CIT Dated: February 19, 1998 Received: February 20, 1998

Dear Dr. Gilbert:

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. A 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 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 requlatory 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 vour 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 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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## 510(k) Number (if known): ____K980666

Device Name: Sigma Diagnostics INFINITY™ AST Reagent

# Indications For Use:

Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-Off).
Division of Clinical Laboratory Devices
510(k) Number. K980666

**Prescription Use**
(Per 21 CFR 801.109)

Over-The-Counter Use _