SENTINEL CHOLINESTERASE LIQUID

K051444 · Sentinel Ch. Srl · DIH · Jun 20, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051444
• Device Name: SENTINEL CHOLINESTERASE LIQUID
• Applicant: Sentinel Ch. Srl
• Product Code: DIH · Clinical Toxicology
• Decision Date: Jun 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3240
• Device Class: Class 1

Intended Use

The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Device Story

Sentinel Cholinesterase Liquid; in vitro diagnostic reagent for quantitative determination of cholinesterase activity in human serum or plasma. Modification enables use on Abbott AEROSET and ARCHITECT c8000 analyzers. Device operates via automated clinical chemistry analysis; provides quantitative results to clinicians for assessment of cholinesterase levels. Used in clinical laboratory settings by trained laboratory personnel. Output assists in diagnosis and monitoring of cholinesterase-related conditions.

Clinical Evidence

Bench testing only. Validation protocols addressed hazards identified in risk analysis (FMEA). Results demonstrated that predetermined acceptance criteria were met for the modified device performance on Abbott AEROSET and ARCHITECT c8000 analyzers.

Technological Characteristics

In vitro diagnostic reagent; liquid formulation. Quantitative enzymatic assay. Designed for use on automated clinical chemistry analyzers (Abbott AEROSET and ARCHITECT c8000).

Indications for Use

Indicated for quantitative determination of cholinesterase in human serum and plasma for the diagnosis and treatment of cholinesterase inhibition and disorders.

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).

Predicate Devices

• Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717 (K981800)

Submission Summary (Full Text)

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# JUN 2 0 2005

# 510(k) Summary

# Submitter's Name/Address

Contact Person

Sentinel CH. S.r.1. Via Principe Eugenio, 5 20155 Milan Italy

Davide Spada Application Specialist Tel: [phone] Fax: [phone]

| Date of Preparation of this Summary: | May 28, 2005 |
|-----------------------------------------------------|--------------------------------|
| Device Trade or Proprietary Name: | Sentinel Cholinesterase Liquid |
| Device Common/Usual Name or<br>Classification Name: | Cholinesterase |
| Classification Number/Class: | DIH, DLI/Class I |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K051444

## Test Description:

Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.

## Substantial Equivalence:

The modified Sentinel Cholinesterase Liquid assay is substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717 (K981800). The modifications consisted of the adaptation of the general purpose Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay to be used on the Abbott AEROSET® and the ARCHITECT® c8000® Analyzers. This (these) modifications did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary.

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#### Intended Use:

The modified Sentinel Cholinesterase Liquid assay is used for the quantitative determination of cholinesterase in serum and plasma.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET System and the ARCHITECT® c 8000 System. For the AEROSET System, the modified Sentinel Cholinesterase Liquid assay method comparison yielded acceptable correlation with the Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717. For the ARCHITECT c8000 system, the modified Sentinel Cholinesterase Liquid assay method comparison yielded acceptable with the modified Sentinel Cholinesterase Liquid on the AEROSET system. These data demonstrate the performance of the modified Sentinel Cholinesterase Liquid assay is substantially equivalent to the performance of the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606.

## Conclusion:

The modified Sentinel Liquid assay is substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 (K981800) assay as demonstrated by results obtained in the studies.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

JUN 2 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Davide Spada Application Specialist Sentinel CH. S.r.l Via Principe Eugenio, 5 20155 Milan Italy

k051444 Re:

Trade/Device Name: Sentinel Cholinesterase Liquid Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: May 28, 2005 Received: June 2, 2005

Dear Mr. Spada:

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 for answer of 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.

Carol C. Benem

Carol C. Benson, M.A. Acting 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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510(k) Number (if known): K051444

Sentinel Cholinesterase Liquid Device Name: Device

Indications For Use:

The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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