Who is the manufacturer of HDL-CHOLESTEROL PLUS 2ND GENERATION?

Roche Diagnostics Corp. filed the 510(k) submission for HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610).

What is the FDA product code for HDL-CHOLESTEROL PLUS 2ND GENERATION?

LBS. It is classified under 21 CFR 862.1475 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for HDL-CHOLESTEROL PLUS 2ND GENERATION?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like HDL-CHOLESTEROL PLUS 2ND GENERATION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HDL-CHOLESTEROL PLUS 2ND GENERATION

K033610 · Roche Diagnostics Corp. · LBS · Dec 5, 2003 · Clinical Chemistry

Device Facts

Record ID	K033610
Device Name	HDL-CHOLESTEROL PLUS 2ND GENERATION
Applicant	Roche Diagnostics Corp.
Product Code	LBS · Clinical Chemistry
Decision Date	Dec 5, 2003
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1475
Device Class	Class 1

Intended Use

HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers.

Device Story

HDL-Cholesterol plus 2nd generation is an in-vitro diagnostic assay for use on automated clinical chemistry analyzers. The device uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons, rendering them resistant to PEG-modified enzymes. HDL-cholesterol is then determined enzymatically via cholesterol esterase and cholesterol oxidase coupled with PEG. The reaction produces a blue quinoneimine dye, the intensity of which is measured photometrically and is directly proportional to the HDL-cholesterol concentration. The assay is intended for clinical laboratory use to assist physicians in diagnosing and managing lipid-related conditions, including atherosclerosis, diabetes, and liver or renal diseases.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of modified reagents and matrix compatibility.

Technological Characteristics

In vitro diagnostic reagents (R1, R2) with modified buffer formulation; supports NH4 heparin plasma matrix. Fundamental scientific technology unchanged.

Indications for Use

Indicated for the direct quantitative determination of HDL-C in human serum and plasma to aid in the 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.

Related Devices

K012286 — MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION · Roche Diagnostics Corp. · Aug 8, 2001
K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) · Sigma Diagnostics, Inc. · Jul 22, 1997
K981224 — DIRECT HDL · Abbott Laboratories · Aug 3, 1998
K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B · Dade Behring, Inc. · Feb 21, 2008
K153435 — Direct HDL Cholesterol (HDL) · Randox Laboratories, Ltd. · Jan 8, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ K033616 DEC - 5 2003 ## 510(k) Summary - HDL-Cholesterol plus 2nd generation | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd Indianapolis IN 46250 (317) 521-3831 Contact person: Sherri L. Coenen Date prepared: November 12, 2003 | | Device Name | Proprietary name: HDL-Cholesterol plus 2nd generation Common name: HDL-Cholesterol Assay Classification name: LDL and VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL | | Device description | The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration and is measured photometrically. | | Intended use | HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers. | | Predicate Device | We claim substantial equivalence to the currently marketed HDL Cholesterol plus Assay. (K000568). | {1}------------------------------------------------ ## 510(k) Summary - HDL-Cholesterol plus 2nd generation, continued Reagent Summary The following table describes the similarities and differences between the HDL-Cholesterol plus 2nd generation and the predicate device. | Topic | HDL-C plus (K000568) | HDL-Cholesterol plus 2nd generation (Modified Device) | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the direct quantitative determination of high-density lipoprotein cholesterol (HDL- cholesterol) in serum and plasma. | HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high- density lipoprotein cholesterol (HDL- C) in human serum and plasma on automated clinical chemistry analyzers. | | Method | Homogeneous enzymatic colorimetric | Same | | Sample type | Serum Li-, Na-Heparin plasma EDTA plasma | Serum Li-, Na-, NH4- Heparin plasma EDTA plasma | | Measuring range | 3 - 120 mg/dl | Same | | Expected values | National Cholesterol Education Program (NCEP) guidelines: < 35 mg/dL : low HDL Cholesterol (major risk factor for CHD) > 60 mg/dL High HDL Cholesterol (negative risk factor for CHD) | National Cholesterol Education Program (NCEP) guidelines: < 40 mg/dL : low HDL Cholesterol (major risk factor for CHD) ≥ 60 mg/dL High HDL Cholesterol (negative risk factor for CHD) | | Formulation R1 | Sulfated alpha-cyclodextrin, dextran sulfate, magnesium chloride, HSDA, ascorbate oxidase (Acremonium), peroxidase (horseradish), MOPS buffer, preservative | Dextran sulfate, magnesium sulfate heptahydrate, HSDA, ascorbate oxidase (Eupenicillium sp., recombinant), peroxidase (horseradish), MOPS buffer, preservative | | Formulation R2 | PEG cholesterol esterase (Pseudomonas), PEG cholesterol oxidase (Pseudomonas), peroxidase (horseradish), 4-aminophenazone, PIPES buffer, preservative | PEG cholesterol esterase (Pseudomonas), PEG cholesterol oxidase (Streptomyces sp., recombinant) peroxidase (horseradish), 4-amino-antipyrine, PIPES buffer, preservative | : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC - 5 2003 Ms. Sherri L. Coenen Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 Re: k033610 > Trade/Device Name: HDL-Cholesterol plus 2nd generation Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: November 12, 2003 Received: November 17, 2003 Dear Ms. Coenen: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). {3}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Putman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): Mit Ko3 3610 Device Name: HDL-Cholesterol plus 2nd generation Indications For Use: HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Carol C Benam/Jean Cooper, DVM Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K033610 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)