MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K013662 · Quantimetrix Corp. · JHO · Mar 8, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013662
• Device Name: MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
• Applicant: Quantimetrix Corp.
• Product Code: JHO · Clinical Chemistry
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Device Story

LipoPrint System LDL Subfractions performs electrophoretic separation of lipoproteins. Device modification adds analysis software to existing hardware (computer, scanner, color printer). Software processes scanned tube images to characterize lipoprotein fractions and subfractions (VLDL, IDL, HDL). Used in clinical laboratory settings by trained personnel. Output provides quantitative data on lipoprotein subfractions to assist clinicians in evaluating lipid metabolism disorders and patient risk assessment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the addition of software to an existing, cleared device.

Technological Characteristics

System utilizes electrophoresis for lipoprotein separation. Hardware includes a scanner, computer, and color printer. Software performs image analysis of electrophoresis tubes. Regulatory software level of concern: moderate.

Indications for Use

Indicated for patients requiring evaluation of lipid metabolism disorders. Used for fasting serum or plasma samples with Total Cholesterol ≥ 100 mg/dl.

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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### 8 2002 MAR

# 5. ATTACHMENTS

#### SPECIAL 510(k) SUMMARY ATTACHMENT A.

This summary of Special 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| 510(k) Number: | K013662 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | LipoPrint™ System LDL Subfractions |
| Common Name: | LipoPrint Test System (Electrophoresis) |
| Classification Name: | Electrophoretic Separation, Lipoproteins |
| Manufacturer: | Quantimetrix Corporation<br>2005 Manhattan Beach Boulevard<br>Redondo Beach, CA 90278<br>Phone [phone] Fax [phone] |
| Contact Person: | Never Gebhard, Ph.D. Director Of R&D 310-536-0006 Ext. 135 |

Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions weriley weiled Quandinena 11 Implementing an the Jip Software sphication is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and general and color of the lovel the lovel the lovel the naracterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, HDL), The level of Indiations of the device modification was determined to be "moderate". This level of concern is for the software only. The . It he ded use of the modified device remains the same as that of the unmodified device.

### INTENDED USE AND INDICATIONS FOR USE:

The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein The Quantinents upopini " -yylent LDE Babileanon or plasma with a Total Choleserol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 8 2002

Gebhard Neyer, Ph.D. Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205

k013662 Re:

Trade/Device Name: LipoPrint™ System LDL Subfractions Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: February 12, 2002 Received: February 19, 2002

Dear Dr. Neyer:

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 noutication. The I Dr in 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 60710 dditionally, for questions on the promotion and advertising of your device, [phone]. Traditions 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 mionination on your responsiver Assistance at its toll-free number [phone] or Manufacturers internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## 5. ATTACHMENTS

#### INDICATIONS FOR USE FORM ATTACHMENT E.

510(K) NUMBER (IF KNOWN):

LipoPrint™ System LDL Subfractions

DEVICE NAME:

013662

INTENDED USE AND INDICATIONS FOR USE:

The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure inpoprotection in and expressions The Quantinetix "Lipoprifi" " yylen" "DE "Burneer"). in fasting serum or plasma with a Total Cholesterol concentration ilpoproven nactions and subliacions from 125 a very an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Kwon

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use
(Per 21 CFR 801.109)

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