OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2

K992086 · Olympus America, Inc. · JIX · Aug 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992086
• Device Name: OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
• Applicant: Olympus America, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Intended for use with Olympus reagents for the establishment of reference points used in the determination of values for specific constituents found in human serum. The five constituents are ceruloplasmin, alpha-1-acidglycoprotein, transferrin, prealbumin, and beta-2-microglobulin.

Device Story

Olympus Serum Protein Multicalibrator 2 serves as a reference standard for clinical laboratory assays; used to establish reference points for quantifying specific serum proteins. Input consists of calibrator material; processed via laboratory instrumentation using Olympus reagents to generate standard curves. Output is a set of reference values for ceruloplasmin, alpha-1-acidglycoprotein, transferrin, prealbumin, and beta-2-microglobulin. Used in clinical laboratory settings by trained technicians. Healthcare providers use the resulting calibration to ensure accuracy of patient serum protein measurements, facilitating diagnosis and monitoring of protein-related clinical conditions.

Technological Characteristics

In vitro diagnostic calibrator; liquid or lyophilized serum-based matrix containing specific protein constituents. Designed for use with Olympus automated clinical chemistry analyzers. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a calibrator for the quantitative determination of ceruloplasmin, alpha-1-acidglycoprotein, transferrin, prealbumin, and beta-2-microglobulin in human serum when used with Olympus reagents.

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

## 400-1999 1999

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11042

K992086 Re:

Trade Name: Olympus® Serum Protein Multicalibrator 2 Regulatory Class: II Product Code: JIX Dated: April 27, 1999 Received: June 21, 1999

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave leviewed your becaon 9 ro(x) xe is substantially equivalent (for the indications for use above and we nave determinou and actresed predicate devices marketed in interstate commerce stated in the enclosure) to logary manote = p.the Medical Device Amendments, or to devices that provi to May 20, 1970, the charances with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general conaufacturing 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 regulations (Fremarks) Approval), it may of says. It is a code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially equiralient determinates 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 inspections, the rood and Drug Nammountin (1 Directory action. In addition, FDA may publish comply with the Grill regareming your device in the Federal Register. Please note: this response to your premarks concerning your 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 regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may
Under the Clinical Laboratory Improvement Amendments of 1988 (CEIFF 09) 2007 (1978)
require a CLIA complexity categorization. To determine if it does, you should contact the ones.
Centers for Disease Control and Prevention (CDC) at [phone].
Centers for Disease Control and Prevention (CDC) at [phone].

Centers for Discase Control and 1914 - 1978

This letter will allow you to begin marketing your device as described in your 10(k) premarket
1978 - The FDA firding of substan This letter will allow you to begin marketing your device to a legally for to a legally marketed
notification. The FDA finding of substantial equivalence of your device to This letter will and with to substantial equivalence of your device to a vogal your device to
predicate device results in a classification for your device and thus, permits y proceed to the market.

proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Organisat If you desire specific dagnostic devices on the prince of contract of cour device,
(301) 594-458. Additionally, for questions on the prince of courtes and [phone]. Additionally, for questions on the promotion and aboveristials de yeallation
[phone]. Additionally, for questions on the promotion of Sundan [phone]. Auditions) [phone]. Also, please note 2.60 States (201) (2010-02-01) Politico (201) School States (201) Colbi of Smark
entitled, "Misbranding by r please contact are of the concerties notification (2) CFA 0017 ) CPN of Small
entitled, "Misbranding by refective to premarket motifican of Small
information on your respons entitled, "Assistance at its toll-free mumber [phone] or [phone], or at its
Manufacturers Assistance ai its toll-free mumber [phone] or [phone], Manufacturers Assistance at Its toll-free humor (000)
internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.h

Sincerely yours,

Steven Sutman

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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510(k) Number (if known):

Device Name:

Olympus Serum,Protein Multicalibrator 2

## Indications for Use:

ansiness for use with Olympus reagents for the establishment of Intended for use with Olympus reagents for the country.
reference points used in the determination of values for specific reference points ascu in to
constituents found in human serum.

The five constituents are ceruloplasmin, alpha-l-acidglycoprotein,
constituents are ceruloplasmin and beta-2-microglobulin. The five constituents are ceruloplabili, and beta-2-microgloulin.

H an Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number. 1992086

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presciption Use (per 21CFR 801.109) OR

Over-the Counter Use_

(Optional Format 1-2-96)