MULTI-LIPID CALIBRATOR

K042550 · Wako Chemicals USA, Inc. · JIX · Nov 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042550
• Device Name: MULTI-LIPID CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Multi-Lipid Calibrator is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

Device Story

Multi-Lipid Calibrator; lyophilized human serum-based material containing HDL-C, LDL-C, Triolein, and Cholesterol. Used in clinical laboratory settings to calibrate Wako assays for lipid panel quantification. Provides reference points for enzymatic and immunoinhibition assay methods. Ensures accuracy of patient lipid measurements by establishing traceability to CDC reference methods. Stability verified via recovery testing at 2-10°C.

Clinical Evidence

No clinical data. Bench testing only. Method comparison studies (N=60) performed against predicate-calibrated assays for Cholesterol, HDL-C, LDL-C, and Triglycerides. Results showed high correlation coefficients (0.9995–1.000) and slopes near 1.0. Stability testing confirmed recovery within ±2.5% of baseline.

Technological Characteristics

Lyophilized human serum containing HDL-C, LDL-C, Triolein, and Cholesterol. Traceable to HECTEF (Total Cholesterol) and CDC Reference Methods (HDL-C, LDL-C, Triglycerides). Storage 2-10°C. No electronic or software components.

Indications for Use

Indicated for use as a reference material for the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum samples when used with Wako's assays.

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

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NOV - 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

Ms. Lori Creasy Regulatory Affairs Specialist Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237

Re: k042550

> Trade/Device Name: Multi-Lipid Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 26, 2004 Received: September 21, 2004

Dear Ms. Creasy:

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) I ms lotter will and w yourse of substantial equivalence of your device to a legally promated noticate 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, rr you don't op other marrotion 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 I va may 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,

Jean M. Cooper, U.S., DVM.

Jean M. Cooper, MS, D.V.M. 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 (if known): K042550

Device Name: Multi-Lipid Calibrator

Indications For Use:

The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Carol Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042550