SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5

K992801 · Sigma Diagnostics, Inc. · CIT · Sep 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992801
• Device Name: SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CIT · Clinical Chemistry
• Decision Date: Sep 28, 1999
• 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 and plasma on both automated and manual systems.

Device Story

In vitro diagnostic reagent kit for quantitative AST measurement in human serum/plasma; utilizes IFCC-recommended enzymatic assay. AST catalyzes amino group transfer from L-aspartate to 2-oxoglutarate, producing oxaloacetate; oxaloacetate reduced to L-malate via MDH and NADH; NADH oxidation monitored via absorbance decrease at 340 nm. Lactate dehydrogenase (LDH) added to reagent to eliminate endogenous pyruvate interference. Used in clinical laboratories on automated or manual systems by laboratory technicians. Results assist clinicians in diagnosing/monitoring tissue damage (heart, liver, muscle).

Clinical Evidence

Bench testing only. Correlation study performed against Sigma Diagnostics AST Reagent (Procedure No. 58, K954839) using 126 plasma samples; regression equation: INFINITY AST = 0.98 (AST 58) + 0.6.

Technological Characteristics

Enzymatic reagent kit; utilizes L-aspartate, 2-oxoglutarate, NADH, Malate dehydrogenase (MDH), and Lactate dehydrogenase (LDH). Principle: UV kinetic rate measurement at 340 nm. Compatible with automated and manual clinical chemistry analyzers.

Indications for Use

Indicated for in vitro quantitative determination of AST in human serum and plasma to assess tissue damage or disease in heart, liver, skeletal muscle, kidney, and erythrocytes, including conditions like myocardial infarction, viral hepatitis, liver necrosis, cirrhosis, and muscular dystrophy.

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)

Reference Devices

• Sigma Diagnostics AST Reagent, Procedure No. 58 (K954839)

Submission Summary (Full Text)

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SEP 2 8 1999

## 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 and plasma 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 1. 2-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.

Correlation studies to Sigma Diagnostics AST Reagent, Procedure No. 58 (K954839) using plasma samples yielded a regression equation of:

INFINITY AST = 0.98 (AST 58) + 0.6 (N=126)

## References

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 8 1999

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics® Clinical Technical Services 545 South Ewing Avenue St. Louis, Missouri 63103

Re: K992801

> Trade Name: Infinity™ AST Reagent (Procedure No. 51) Regulatory Class: II Product Code: CIT Dated: August 16, 1999 Received: August 19, 1999

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 legally marketed predicate 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 regulatory action. In addition, FDA may publish further announcements 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.

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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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Sigma Diagnostics INFINITY™ AST Reagent

## Indications For 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 and plasma on both automated and manual systems.

Sean Cooper

(Division Sign-Off) Division of Clinical Laborate L vices 510(k) Number

(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)

OH

Over-The-Counter Use _