LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40

K041927 · Diagnostic Chemicals , Ltd. · MRR · Nov 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041927
• Device Name: LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Device Story

LDL-Advance Assay is a quantitative colorimetric in vitro diagnostic test for serum LDL cholesterol. The assay utilizes two wet reagents to selectively bind non-LDL lipoproteins via phosphorus compounds and detergents. Remaining LDL cholesterol undergoes enzymatic reactions involving cholesterol esterase, cholesterol oxidase, and peroxidase to produce a quinone pigment. The resulting color intensity, measured spectrophotometrically at 600 nm, is directly proportional to LDL concentration. The device is intended for professional use on Hitachi 717 and 917 analyzers in clinical laboratory settings. Results assist healthcare providers in diagnosing and managing lipid-related conditions, including atherosclerosis and metabolic disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative colorimetric assay using enzymatic reaction (cholesterol esterase/oxidase/peroxidase). Measures absorbance at 600 nm. Compatible with Hitachi 717 and 917 analyzers. Performance validated per NCCLS guidelines EP5, EP6, and EP-7. Reagents include phosphorus compounds and detergents for selective binding.

Indications for Use

Indicated for the quantitative determination of LDL cholesterol in serum for patients requiring diagnosis and treatment 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

NOV 2 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Olscamp Regulatory Affairs Coordinator, External Diagnostics Chemical Limited 16 McCarville Street Charlottetown, PE Canada C1E 2A6

k041927 Re:

> Trade/Device Name: LDL-ADVANCE Assay, Cat. No. 279-20,279-40 Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: October 13, 2004 Received: October 14, 2004

Dear Ms. Olscamp:

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 (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely, yours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

K041927 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

LDL-ADVANCE Assay, Cat. No. 279-20, 279-40 Device Name:

Indications for Use:

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## For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.

A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

| Prescription Use: | |
|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | |
| And/or | |
| Over-the-Counter Use (OTC): | |
| (21 CFR 807 Subpart C) | |

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Bener
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K041927