OLYMPUS SERUM PROTEIN MULTICALIBRATOR,

K981854 · Olympus Diagnostica GmbH · JIT · Aug 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981854
• Device Name: OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
• Applicant: Olympus Diagnostica GmbH
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.

Device Story

Olympus Serum Protein Multicalibrator (ODR3023) is a calibration product used in clinical laboratory settings. It is designed for use with Olympus automated clinical chemistry analyzers. The calibrator provides reference values for specific serum proteins: α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin, and ß-2-microglobulin. By establishing a calibration curve on the analyzer, it enables accurate quantification of these proteins in patient serum samples. This process assists healthcare providers in diagnosing and monitoring conditions associated with these specific proteins. The device is intended for prescription use by trained laboratory personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator for automated clinical chemistry analyzers. Formulated for specific protein assays (α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin, ß-2-microglobulin).

Indications for Use

Indicated for use in Olympus automated clinical chemistry analyzers to calibrate assays for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin, and ß-2-microglobulin. Intended for professional clinical laboratory use.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 1998

Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747

Re: K981854 Serum Protein Multicalibrator Requlatory Class: II Product Code: JIT Dated: July 21, 1998 Received: July 23, 1998

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or = = requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): Not assigned yet

Device Name:

Olympus Serum Protein Multi-Calibrator

Indications for Use:

The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------------------------------------------|
| Prescription Use ✓ (per 21CFR 801.109) OR | Over-the Counter Use (Optional Format 1-2-96) |
| | (Division Sign-Off) Division of Clinical Laboratory Devices |
| 510(k) Number | K981854 |