OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

K032665 · Olympus America, Inc. · JIX · Nov 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032665
• Device Name: OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
• Applicant: Olympus America, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Olympus Lyophilized 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 Calibrator functions as a two-level chemistry calibrator; used to establish calibration curves for OLYMPUS analyzers. Device is a lyophilized product; reconstituted for use in clinical laboratory settings by trained laboratory personnel. Provides reference values for OLYMPUS methodologies to ensure accuracy of patient sample testing. Benefits patient by ensuring reliable, standardized diagnostic results across chemistry assays.

Clinical Evidence

No clinical data. Bench testing only. Performance is established through analytical validation protocols, including 10-replicate runs per analyte, comparison against NIST/CAP reference materials, and adherence to precision goals (33% of CLIA/CAP total allowable error).

Technological Characteristics

Two-level lyophilized human serum-based calibrator; includes diluent. Analyte constituents include albumin, bicarbonate, bilirubin, calcium, cholesterol, creatinine, glucose, inorganic phosphorous, iron, magnesium, total protein, triglyceride, UIBC, urea nitrogen, and uric acid. Designed for use on Olympus clinical chemistry analyzers. Value assignment is traceable to national standards.

Indications for Use

Indicated for use as a two-level general-purpose chemistry calibrator for Olympus clinical chemistry analyzers to establish reference values for system 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 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Campbell Senior Manager, RA/QA Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104

Re: k032665

> Trade/Device Name: Olympus Lyophilized Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 27, 2003 Received: August 28, 2003

Dear Mr. Campbell:

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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 103266 Indications for Use Statement

510(k) Number (if known):

03265

Olympus Lyophilized Calibrator

Indications for Use:

Device Name:

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

Carol Benson (B Jean Cooper, DVM
Division Sign-Off

Division sign on

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032665

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Optional Format 1-2-96) (per 21 CFR 801.109)

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