MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
Device Facts
| Record ID | K012286 |
|---|---|
| Device Name | MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION |
| Applicant | Roche Diagnostics Corp. |
| Product Code | LBS · Clinical Chemistry |
| Decision Date | Aug 8, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
Intended Use
The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of HDL-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.
Device Story
In vitro diagnostic reagent system for COBAS Integra analyzers; measures HDL-cholesterol concentration in serum and plasma samples. Principle: magnesium sulfate and dextran sulfate form water-soluble complexes with LDL, VLDL, and chylomicrons, rendering them resistant to PEG-modified enzymes. HDL-cholesterol is measured enzymatically via cholesterol esterase and cholesterol oxidase coupled with PEG. Output: color intensity of blue quinoneimine dye, measured as increase in absorbance at 583 nm. Used in clinical laboratories by trained personnel. Results assist physicians in diagnosing and managing lipid-related conditions like atherosclerosis and diabetes.
Clinical Evidence
No clinical data provided; substantial equivalence is based on analytical performance and comparison of assay parameters to the predicate device.
Technological Characteristics
In vitro diagnostic reagent system; enzymatic colorimetric assay (cholesterol esterase/oxidase); detection via spectrophotometry at 583 nm; reagents include magnesium sulfate, dextran sulfate, and PEG-modified enzymes. Designed for use on COBAS Integra automated analyzer systems.
Indications for Use
Indicated for quantitative determination of HDL-cholesterol in serum and plasma for patients requiring diagnosis or treatment monitoring of lipid disorders, including diabetes mellitus, atherosclerosis, and liver or 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 HDL-Cholesterol plus 2nd generation assay (K963213)
Related Devices
- K973284 — COBAS INTEGRA HDL-CHOLESTEROL DIRECT · Roche Diagnostic Systems, Inc. · Dec 18, 1997
- K033610 — HDL-CHOLESTEROL PLUS 2ND GENERATION · Roche Diagnostics Corp. · Dec 5, 2003
- K971526 — ACE HDL-C REAGENT · Schiapparelli Biosystems, Inc. · May 21, 1997
- K012287 — MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION · Roche Diagnostics Corp. · Aug 7, 2001
- K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) · Sigma Diagnostics, Inc. · Jul 22, 1997
Submission Summary (Full Text)
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## AUG - 8 2001
| 510(k) Summary | K012286 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br><br>Contact Person: Sherri L. Coenen<br><br>Date Prepared: July 17, 2001 |
| Device Name | Proprietary name: HDL-Cholesterol plus 2nd Generation |
| | Common name: HDL-Cholesterol |
| | Classification name: Lipoprotein test system |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Roche/Hitachi<br>HDL-Cholesterol plus 2nd generation assay (K963213). |
| Device<br>Description | The HDL-Cholesterol plus 2nd Generation test principle uses magnesium<br>sulfate and dextran sulfate to form water-soluble complexes with LDL,<br>VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The<br>cholesterol concentration of HDL-cholesterol is determined enzymatically by<br>cholesterol esterase and cholesterol oxidase coupled with PEG. The color<br>intensity of the blue quinoneimine dye formed is directly proportional to the<br>HDL-cholesterol concentration. It is determined by measuring the increase in<br>absorbance at 583 nm. |
| Intended use | The cassette COBAS Integra HDL-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 HDL-cholesterol concentration<br>in serum and plasma. |
| Indications for 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 Equivalence | The proposed device is the HDL-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 HDL-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 HDL-Cholesterol plus 2nd generation assay as applied<br>to the Roche/Hitachi family of analyzers. |
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## 510(k) Summary, Continued
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract representation of a bird or a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 2001
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
510(k) Number: K012286 Re: Trade/Device Name: HDL-Cholesterol plus 2nd Generation Regulation Number: 862.1475 Regulatory Class: I, reserved Product Code: LBS 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 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 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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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 notification. The FDA inding of successification 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 If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 809.10 for in this daglestions on the promotion and advertising of your device, (301) 394-4588. Additionally, for quest to on a processed on a more and the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please of Complete please contact the Office of Comphanol at (201) of the stimation" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsioniass are unber (800) 638-2041 or (301) 443-6597 or at its Manufacturers 71851502139999 w.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Stoven 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
Device Name: HDL-Cholesterol plus 2nd Generation
Indications For Use:
The cassette COBAS Integra HDL-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 HDL-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 prasma. Libertes 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. Juan Capr
