WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

K040918 · Wako Chemicals USA, Inc. · JJX · May 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040918
• Device Name: WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Wako Quality control is intended for use as an assay quality control serum to monitor the precision of laboratory testing procedures for the Wako Lipid assays such as Triglyceride, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein.

Device Story

Wako Lipid Control is a liquid quality control serum; used in clinical laboratories to monitor precision of lipid assay procedures. Product consists of human-matrix control material provided in two levels; stored at 2-8 °C. Device serves as a reference to verify laboratory testing performance for specific lipid analytes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid human-matrix quality control serum; 2 levels; 5ml vial volume; storage 2-8 °C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for lipid assays, including Total Cholesterol, LDL-Cholesterol, Triglycerides, NEFA C, Free Cholesterol, and beta-Lipoprotein.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 7 2004

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

Re: k040918

Trade/Device Name: Wako Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 26, 2004 Received: April 9, 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 Feccral 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 docs 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 premailed 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,

Jean M. Cooper, US, 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):

Device Name: Wako Lipid Control

Indications For Use: The Wako Quality Control is intended for use as an assay quality maroations in of ooo. The transecision of laboratory testing procedures for the Wako Control scrain to monitor the processor of L-Cholesterol, LDL-Cholesterol, lipid assuy cash as Thigyonins, NEFA C, Free Cholesterol and beta Lipoprotein assays.

X 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)

> H. Office of In Vitro Diagnostic Devices (OIVD) Concurrence of

Division Sign Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040118