OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

K043460 · Olympus America, Inc. · JIX · Jan 31, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043460
• Device Name: OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
• Applicant: Olympus America, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

Device Story

Olympus Lyophilized Chemistry Calibrator is a two-level, general-purpose chemistry calibrator; used to calibrate Olympus analyzers; ensures accuracy of clinical chemistry testing; supports clinical decision-making by providing reference points for patient sample analysis; intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data. Bench testing only. Stability was verified through open-vial aging studies (2-8 °C) and accelerated stability testing (37 °C). Traceability of constituent analytes was established via NIST standards or third-party reference materials. Lactic acid concentration was verified using an Olympus colorimetric kit.

Technological Characteristics

Lyophilized, two-level chemistry calibrator; designed for use with Olympus analyzers and methodologies; Class II device (21 CFR 862.1150).

Indications for Use

Indicated for use as a two-level general-purpose chemistry calibrator for Olympus analyzers using Olympus methodologies.

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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 1 2005

Ms. Bev Harding RA Analyst Olympus America Inc. 3131 West Royal Lane Irving, TX 75063-3104

k043460 Re:

Trade/Device Name: Olympus Lyophilized Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 14, 2004 Received: December 15, 2004

Dear Ms. Harding:

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/industry/support/index.html

Sincerely yours,

Sean M. Csogen, MS, DUM

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 Statement

510(k) Number (if known):

Device Name:

Olympus Lyophilized Chemistry Calibrator

Indications for Use:

The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

Carol Benson
Division Sign-Off

Division Sign-

OR

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K043460

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

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