INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)

K980667 · Sigma Diagnostics, Inc. · CHH · Apr 21, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980667
• Device Name: INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum.

Device Story

The INFINITY™ Cholesterol Reagent is an in vitro diagnostic chemical assay used to measure cholesterol levels in human serum. The device utilizes an enzymatic colorimetric method: cholesterol esters are hydrolyzed by cholesterol esterase (CE) to free cholesterol and fatty acids; free cholesterol is oxidized by cholesterol oxidase (CO) to produce hydrogen peroxide; hydrogen peroxide reacts with hydroxybenzoic acid and 4-aminoantipyrine in the presence of peroxidase (POD) to form a quinoneimine dye. The resulting chromophore is quantitated spectrophotometrically at 500-550 nm. The reagent is intended for use in clinical laboratory settings by trained personnel. The quantitative output provides clinicians with data to assess lipid metabolism, liver and biliary function, and cardiovascular disease risk, aiding in the diagnosis and classification of hyperlipoproteinaemias.

Clinical Evidence

No clinical data provided. The device relies on established enzymatic biochemical principles (Allain et al. and Roeschlaus methods) for in vitro diagnostic testing.

Technological Characteristics

Enzymatic colorimetric assay. Reagents: Cholesterol esterase, cholesterol oxidase, peroxidase, hydroxybenzoic acid, and 4-aminoantipyrine. Detection: Spectrophotometric measurement of quinoneimine dye at 500-550 nm (or 600/650 nm for bichromatic analyzers). Stable liquid solution formulation.

Indications for Use

Indicated for the in vitro quantitative, diagnostic determination of cholesterol in human serum to assist in the diagnosis and classification of hyperlipoproteinaemias and as an indicator of liver function, biliary function, intestinal absorption, coronary artery disease risk, thyroid function, and adrenal disease.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• TRACE Scientific Cholesterol Reagent Kit (K962890)

Submission Summary (Full Text)

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APR 2 1 1998

K980667

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFINITYTM Cholesterol Reagent, Procedure 401

Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum.

Measurement of serum cholesterol levels can serve as an indicator of liver function, biliary function, intestinal absorption, propensity toward coronary artery disease, thyroid function and adrenal disease. Cholesterol levels are important in the diagnosis and classification of hyperlipoproteinaemias. Stress, age, gender, hormonal balance and pregnancy affect normal cholesterol levels. 1,2

This reagent is based on the formulation of Allain et al.3 and the modification of Roeschlaus with further improvements to render the reagent stable in solution.

- Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase (CE) to cholesterol 1. and free fatty acids. Cholesterol Esters __CE__ Cholesterol + Fatty Acids
- Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase 2. (CO) to cholest-4-en-3-one and hydrogen peroxide .. Cholesterol + O2 _CQ__CQ__ Cholest-4-en-3-one + H2O2
- 3. The hydrogen peroxide combines with hydroxybenzoic acid (HBA) and 4aminoantipyrine (AAP) in the presence of peroxidase (POD) to form a chromophore (quinoneimine dye) which may be quantitated at 500-550 nm. For bichromatic analyzers the blank wavelength should be set to 600 or 650 nm. 2H2O2 + HBA + 4AAP _ POD_> Quinoneimine Dye + 4H2O

The Sigma Diagnostics INFINITY™ Cholesterol Reagent Kit (Procedure No. 401) is substantially equivalent to, and is the same product as the TRACE Scientific Cholesterol Reagent Kit cleared by FDA as K962890.

## References

- Searcy R.L. "Diagnostic Biochemistry." McGraw-Hill, New York, NY. 1969. 1.
- Ellefson R.D. and Caraway W.T. "Fundamentals of Clinical Chemistry." Ed. Tietz N.W. 2. 1976; p 506.
- Allain C.C., Poon L.S., Chan C.S.G., Richmond W. and Fu P.C. Clin. Chem., 1974; 3. 20:470-475.
- 4. Roeschlau P., Bernt E. and Gruber W.A. Clin. Chem. Clin. Biochem. 1974; 12:226.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 21 1996

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

Re : K980667 INFINITY™ Cholesterol Reagent (Procedure No. 401) Regulatory Class: I Product Code: СНН 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 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 Druq 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.

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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 qeneral 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

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Page 1__of ___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sigma Diagnostics INFINITY™ Cholesterol Reagent_

## Indications For Use:

Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum.

(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. K-980667

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________