LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01

K991664 · A.P. Total Care, Inc. · LBS · Aug 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991664
• Device Name: LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
• Applicant: A.P. Total Care, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

Device Story

In vitro diagnostic reagent for automated, quantitative determination of LDL-cholesterol in serum samples. Used in clinical laboratory settings by trained personnel. Reagent facilitates measurement of LDL levels to assist clinicians in diagnosing and managing lipid disorders, atherosclerosis, diabetes mellitus, and liver/renal diseases. Output is a quantitative concentration value used to inform clinical decision-making regarding patient lipid management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for automated chemistry analyzers. Quantitative colorimetric or enzymatic assay principle. Standalone reagent system.

Indications for Use

Indicated for the quantitative determination of LDL-cholesterol in serum for the diagnosis and treatment of lipid disorders, atherosclerosis, and liver or renal diseases in patients.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 19 1999

A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 70 Hawley Avenue Bridgeport, Connecticut 06606

Re: K991664 Trade Name: LDL Cholesterol Regulatory Class: I reserved Product Code: LBS Dated: July 12, 1999 Received: July 26, 1999

Dear Mr. Leon:

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 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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### 510 (k) NUMBER (IF KNOWN): K991664

# DEVICE NAME: LDL-CHOLESTEROL

## INDICATIONS FOR USE:

This LDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of low-density lipoprotein-cholesterol (LDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

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

Concurrence of CDRH, Office of Device Evaluation (OED)

| | <div><span style="text-decoration: overline;">Veronica Halma for Dean Cooper</span></div> <div>(Division Sign-Off)</div> <div>Division of Clinical Laboratory Devices</div> |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | <span style="text-decoration: overline;">991664</span> |

| Prescription Use | OR | Over-The-Counter-Use |
|---------------------|----|--------------------------|
| (Per 21 CFR 801.109 | | (Optional Format 1-2-96) |