JAS HDL CHOLESTEROL (AUTOMATED) REAGENT

K021671 · Jas Diagnostics, Inc. · LBS · Jul 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021671
• Device Name: JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
• Applicant: Jas Diagnostics, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers. HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

Device Story

Device is an in vitro diagnostic reagent for quantitative HDL cholesterol measurement in human serum. Used on automated chemistry analyzers in clinical laboratory settings. Reagent facilitates chemical reaction allowing photometric measurement of HDL cholesterol levels. Results provided to clinicians to assess patient risk for coronary heart disease and coronary artery disease; assists in diagnosis and treatment monitoring of lipid disorders.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the reagent system.

Technological Characteristics

In vitro diagnostic reagent for automated chemistry analyzers. Principle of operation involves chemical assay for quantitative HDL cholesterol determination. Form factor is liquid reagent for laboratory use.

Indications for Use

Indicated for the in vitro, quantitative determination of HDL cholesterol in human serum to aid in the diagnosis and treatment of disorders involving low HDL cholesterol, which is associated with increased risk of coronary heart disease and coronary artery disease.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rackville MD 20850

## JUL 1 9 2002

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

Re: k021671

> Trade/Device Name: HDL Cholesterol (Automated) REAGENT Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system; Regulatory Class: Class II Product Code: LBS: JIX; JJX Dated: May 1, 2002 Received: May 21, 2002

Dear Mr. Johnston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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): | N/A K021671 |
|---------------------------|-------------------------------------|
| Device Name: | HDL Cholesterol (Automated) REAGENT |
| Indications for Use: | |

Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.

HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

lan
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021671

(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)