HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

K041926 · Diagnostic Chemicals , Ltd. · JIX · Nov 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041926
• Device Name: HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.

Device Story

HDL/LDL-Advance Calibrator is a lyophilized human serum-based product used to calibrate HDL and LDL cholesterol assays. The device is reconstituted with deionized water by laboratory personnel in a clinical chemistry setting. It contains HDL added gravimetrically from certified primary material and LDL derived from an in-house human serum pool. Values are assigned via repeated testing using commercially available assays. The calibrator ensures the accuracy of clinical chemistry analyzers when measuring lipoprotein levels, which aids clinicians in assessing patient lipid profiles and cardiovascular risk.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum matrix; reconstituted with deionized water. Contains HDL (gravimetrically added from certified primary material) and LDL (human serum pool). Stability: 7 days at 2-8°C post-reconstitution. All human source material tested non-reactive for HBsAg, HCV, and HIV-1/2.

Indications for Use

Indicated for in vitro diagnostic use to calibrate HDL and LDL cholesterol assays in human serum.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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 (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming a wing-like shape, and the overall design is simple and monochromatic.

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 CIE 2A6

Re: k041926

Trade/Device Name: HDL/ LDL-ADVANCE Calibrator, Cat. No. SE-278 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX 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) 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 [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. Loks

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

______________________________________________________________________________________________________________________________________________________________________________ K041926 510(k) Number:

#### HDL/LDL-ADVANCE Calibrator, Cat. No. SE-278 Device Name:

## Indications for Use:

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

HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Carol C. Benson
Bidder Sign Off

Division Sign-Off

e of In Vitro Diagnos e Evaluation and Safety

510(k) Ko 41926