OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)

K030045 · Olympus America, Inc. · DIH · Feb 21, 2003 · Clinical Toxicology

Device Facts

• Record ID: K030045
• Device Name: OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
• Applicant: Olympus America, Inc.
• Product Code: DIH · Clinical Toxicology
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3240
• Device Class: Class 1

Intended Use

Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers. Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

Device Story

Olympus Cholinesterase Reagent is an in vitro diagnostic reagent used with Olympus clinical chemistry analyzers. It measures cholinesterase concentrations in human serum and plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The quantitative results provided by the analyzer assist healthcare providers in assessing liver function, identifying enzyme variants, evaluating risks associated with succinylcholine administration, and monitoring potential organophosphorus insecticide toxicity. The reagent facilitates clinical decision-making by providing objective biochemical data regarding patient cholinesterase levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for clinical chemistry analysis. Designed for use on Olympus family clinical chemistry analyzers. Class I device (21 CFR 862.3240).

Indications for Use

Indicated for the determination of cholinesterase concentrations in human serum and plasma to assess liver function, investigate cholinesterase enzyme variants, predict susceptibility to prolonged apnea following succinylcholine administration, and monitor organophosphorus insecticide exposure.

Regulatory Classification

Identification

A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 2 1 2003

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

Re: k030045

> Trade/Device Name: Olympus Cholinesterase Reagent Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: January 6, 2003 Received: January 6, 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. Ilsting 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 (OS) 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 Sutman

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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## Indications for Use Statement

510(k) Number (if known):

Device Name: Indications for Use: Olympus Cholinesterase Reagent

Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers.

Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

Lron Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K030045

0063

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
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