MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

K012287 · Roche Diagnostics Corp. · MRR · Aug 7, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012287
• Device Name: MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
• Applicant: Roche Diagnostics Corp.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Aug 7, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration in serum and plasma.

Device Story

In vitro diagnostic reagent system for COBAS Integra analyzers; measures LDL-Cholesterol in serum/plasma samples. Principle: selective micellary solubilization of LDL-cholesterol via nonionic detergent; interaction with sugar compound; enzymatic cholesterol esterase/cholesterol oxidase coupling reaction. Produces blue quinoneimine dye; color intensity measured via absorbance at 583 nm. Used in clinical laboratory settings by trained personnel. Output provides quantitative LDL-Cholesterol concentration; assists clinicians in diagnosing/managing lipid disorders, atherosclerosis, and metabolic diseases.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance and technological similarity to the predicate device.

Technological Characteristics

In vitro diagnostic reagent system; enzymatic colorimetric assay (cholesterol esterase/cholesterol oxidase). Detection via spectrophotometry (absorbance at 583 nm). Designed for use on COBAS Integra automated analyzer systems.

Indications for Use

Indicated for quantitative measurement of LDL-Cholesterol in serum and plasma to aid in diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and liver/renal diseases.

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.

Predicate Devices

• Roche/Hitachi LDL-Cholesterol plus 2nd generation assay (K974733)

Submission Summary (Full Text)

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| 510(k) Summary | K012287 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements established in the Food and Drug<br>Administration's guidance document entitled "The New 510(k) Paradigm:<br>Alternate Approaches to Demonstrating Substantial Equivalence in Premarket<br>Notifications", the following information provides sufficient detail to<br>understand the basis for a determination of substantial equivalence. |
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 521 - 3831 |
| | Contact Person: Sherri L. Coenen<br>Date Prepared: July 17, 2001 |
| Device Name | Proprietary name: LDL-Cholesterol plus 2nd Generation |
| | Common name: LDL-Cholesterol |
| | Classification name: Lipoprotein test system |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Roche/Hitachi<br>LDL-Cholesterol plus 2nd generation assay (K974733). |
| Device<br>Description | The LDL-Cholesterol plus 2nd Generation test principle is based on the<br>selective micellary solubilization of LDL-cholesterol by a nonionic detergent<br>and the interaction of a sugar compound and lipoproteins. The inclusion of a<br>sugar compound and a detergent in the enzymatic method for cholesterol<br>determination (cholesterol esterase cholesterol oxidase coupling reaction)<br>enables the selective determination of LDL-cholesterol. The color intensity of<br>the blue quinoneimine dye formed is directly proportional to the LDL-<br>Cholesterol concentration. It is determined by measuring the increase in<br>absorbance at 583 nm. |
| Intended use | The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation contains<br>an in vitro diagnostic reagent system intended for use on COBAS Integra<br>systems for the quantitative determination of LDL-Cholesterol concentration<br>in serum and plasma. |
| Indications for<br>Use | A lipoprotein test system is a device intended to measure lipoprotein in serum<br>and plasma. Lipoprotein measurements are used in the diagnosis and<br>treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and<br>various liver and renal diseases. |
| Substantial<br>Equivalence | The proposed device is the LDL-Cholesterol plus 2nd generation reagent<br>packaged for and applied to the COBAS Integra family of analyzers. The<br>COBAS Integra family application described in this submission is, in our<br>opinion, substantially equivalent to the predicate device. |
| Comparison to<br>predicate<br>device | The COBAS Integra application of the LDL-Cholesterol plus 2nd generation<br>assays has the same intended use and indication for use, the same scientific<br>principle, the same formulation and similar application parameters as the<br>predicate device, the LDL-Cholesterol plus 2nd generation assay as applied to<br>the Roche/Hitachi family of analyzers. |

్రామం

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## 510(k) Summary, Continued

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AUG - 7 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

510(k) Number: K012287 Re: Trade/Device Name: LDL-Cholesterol plus 2nd Generation Regulation Number: 862.1475 Regulatory Class: I, reserved by limitations Product Code: MRR Dated: July 17, 2001 Received: July 20, 2001

Dear Ms. Coenen:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameradments, 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 ur general of 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 ( remainer ripps of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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## Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and w you to organ substantial equivalence of your device to a legally marketed notification. The I Dr Intelligence scation 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 additionally 607.10 for in in in the promotion and advertising of your device, [phone]. 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 miountation on your responsionies and in the more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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## Indications for Use Statement

510(k) Number (if known): N/A K012287

Device Name: LDL-Cholesterol plus 2nd Generation

Indications For Use:

The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation (HDL-C) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration in serum and plasma.

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.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Kesia Alexander Sr. Iian Cooper

510/k) Number