HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

K041928 · Diagnostic Chemicals , Ltd. · LBS · Nov 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041928
• Device Name: HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: LBS · 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 high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.

Device Story

HDL-Advance Assay is a quantitative colorimetric assay for serum HDL cholesterol. The device uses two wet reagents to selectively inhibit non-HDL lipoproteins. The remaining HDL cholesterol reacts with cholesterol esterase, cholesterol oxidase, and peroxidase to produce a quinone pigment. The color intensity is measured spectrophotometrically at 600 nm. The assay is performed on Hitachi 717 and 917 analyzers in a clinical laboratory setting by professional staff. The resulting concentration is used by clinicians to diagnose and manage lipid disorders, atherosclerosis, and associated metabolic or organ diseases.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical bench testing, including precision (n=80, total CV 2.5-4.3%), linearity (0.119-180 mg/dL), and interference testing (hemoglobin, bilirubin, lipemia). Method comparison with the predicate device (n=50) showed high correlation (R=0.9987, Deming slope 0.996).

Technological Characteristics

Quantitative colorimetric assay; utilizes cholesterol esterase, cholesterol oxidase, and peroxidase enzymes. Measures quinone pigment spectrophotometrically at 600 nm. Designed for use on Hitachi 717 and 917 analyzers. Performance evaluated per NCCLS guidelines EP5-A (precision), EP6 (linearity), and EP-7 (interference).

Indications for Use

Indicated for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum. Used in the diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use.

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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Public Health Service

2098 Gaither Road Rockville MD 20850

Food and Drug Administration

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved shapes, possibly representing human figures or abstract forms. The logo is black and white.

NOV 2 3 2004

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

k041928 Re:

k041928
Trade/Device Name: HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS 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 We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is subscripes marked in inters referenced above and have determined the devices marketed president devices marketed in interstate for use stated in the encrosule) to regally mancede promises of the Medical Device American son to commerce prior to May 28, 1970, the chacultions of the Federal Food, Drug, devices that have been recults in accordance who f a prevarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval actuals provisions of the Act . and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to urements for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the Fectiners and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), p If your device is classified (See above) into enter regulations affecting your device
it may be subject to such additional controls. Existing major regulation Fl it may be subject to such additional controls. "Daising may begins 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Fars 800 to 895. can be found in Title 21, Code of Pederal resguing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substitute with other requirements of the Act
that FDA has made a determination that your device of the Frequirements of the Act that FDA has made a delermination that your arres by other Federal agencies. You must as and listing or any Federal statures and regulations administered of other to: registration and listing (21
comply with all the Act's requirements, including, but not instruments areastic comply with an the Act s requirements, morants 801 and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 801 and 2017), 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) This letter will allow you to begin makesting your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA Intellig of bassand on 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, a If you desire specific information acount in approvine, please contact the Office of In
or questions on the promotion and advertising of your concess note the or questions on the promotion and activities of your and Safety at [phone]. Also, please note the Vitro Diagnostic Device Lyanation and Bareey at (30) and Seatings on "C1CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket with and on the regulation entitled, "Misolanding by reference vo presponsibilities under the Act from the You may obtain other general information on your responsible in the sistance 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. Parks

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

| 510(k) Number: | K041928 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B |
| Indications for Use: | For the quantitative determination of high 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. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

പ്പ്-Prescription Use:

And/or

Over-the-Counter Use (OTC): __

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Carol Benam

n Sicin-f

Office of In Vitro Diagnostic Device Evaluation and Satety

510(k) K041928