ADVIA 1650 CHOLINESTERASE ASSAY

K013750 · Bayer Diagnostics Corp. · DIH · Jan 18, 2002 · Clinical Toxicology

Device Facts

• Record ID: K013750
• Device Name: ADVIA 1650 CHOLINESTERASE ASSAY
• Applicant: Bayer Diagnostics Corp.
• Product Code: DIH · Clinical Toxicology
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3240
• Device Class: Class 1

Intended Use

The Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase enzyme activity in human serum, plasma (lithium heparin) on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of organophosphorus poisoning and certain liver diseases such as cirrhosis, acute and chronic hepatitis.

Device Story

In vitro diagnostic assay for Bayer ADVIA 1650 system; measures cholinesterase enzyme activity in human serum or lithium heparin plasma. Used in clinical laboratory settings by trained personnel. Input: patient serum/plasma samples. Process: automated biochemical analysis on ADVIA 1650 platform. Output: quantitative cholinesterase activity levels (U/L). Results assist clinicians in diagnosing/treating organophosphorus poisoning and liver conditions like cirrhosis or hepatitis. Benefits include rapid, automated assessment of enzyme activity to guide clinical management.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies (Total CV 0.9-1.1%) and method comparison against Kodak Vitros 250 (N=58, r=0.994). Interference testing showed minimal impact from bilirubin, hemoglobin, and lipids (all <1% change). Analytical range established at 1,500-30,000 U/L.

Technological Characteristics

In vitro diagnostic reagent system for automated clinical chemistry analyzer. Sensing principle: enzymatic activity measurement. Connectivity: integrated with Bayer ADVIA 1650 system. Calibration: absolute calibration factor. Analytical range: 1,500-30,000 U/L.

Indications for Use

Indicated for measurement of cholinesterase enzyme activity in human serum or lithium heparin plasma to aid in diagnosis and treatment of organophosphorus poisoning and liver diseases (cirrhosis, acute/chronic hepatitis).

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

• Kodak Vitros 250/ Cholinesterase (K913198, K912217)

Submission Summary (Full Text)

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# JAN 1 8 2002-10(k) SUMMARY OF SAFETY AND EFFECTIVENESS Cholinesterase method for Bayer ADVIA® 1650 System

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

The assigned 510(k) number is: K013750

## 1. Intended Use

The Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase enzyme activity in human serum, plasma (lithium heparin) on the Bayer ADVIA® 1650 Such measurement is used in the diagnosis and treatment of organophosphorus System. poisoning and certain liver diseases such as cirrhosis, acute and chronic hepatitis.

## 2. Predicate Device/ Method

| Product Name | Reagent Part # | Calibrator Part # | Predicate Device # |
|----------------------------------|----------------|-------------------|--------------------|
| Kodak Vitros 250/ Cholinesterase | 800 4707 | 120 4247 | K913198, K912217 |

## 3. Device / Method

| Product Name | REF | Calibrator Part # |
|-----------------------------|-------------|------------------------------------------------|
| ADVIA 1650 / Cholinesterase | B01-4605-01 | N/A,<br>(absolute calibration<br>factor 43287) |

#### Imprecision

| ADVIA 1650<br>Cholinesterase | | Kodak Vitros 250<br>Cholinesterase | |
|------------------------------|----------------|------------------------------------|----------------|
| Level<br>(U/L) | Total<br>CV(%) | Level<br>(U/L) | Total<br>CV(%) |
| 4235.86 | 1.1 | 4350 | 4.3 |
| 6978.97 | 0.9 | 6310 | 4.0 |
| 12318.49 | 1.1 | | |

#### Correlation (Y=ADVIA 1650 Cholinesterase, X= Vitros 250 cholinesterase)

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (U/L) | r | Sample Range (U/L) |
|-----------------------|-----------------------|----|---------------------|-----------|-------|--------------------|
| Serum | Kodax Vitros 250 | 58 | Y=1.325X+228.69 | 306.57 | 0.994 | 1560.0-11090.0 |
| Plasma(Y) vs Serum(X) | ADVIA 1650 | 40 | Y=0.973X+130.33 | 359.9 | 0.984 | 5051.4-14467.1 |

#### Interfering Substances

| Interfering | Interfering Sub. | Control | Test Sample | Effect |
|--------------------------|------------------|---------|-------------|------------|
| Substance | Conc. (mg/dL) | (U/L) | (U/L) | (% change) |
| Bilirubin (unconjugated) | 25 | 7705.57 | 7651.71 | -0.70 |
| Bilirubin (conjugated) | 25 | 7561.88 | 7633.48 | +0.95 |
| Hemoglobin | 520 | 9659.20 | 9701.98 | +0.44 |
| Lipids (Intralipid) | 520 | 9655.47 | 9643.34 | -0.13 |

#### Analytical Range

Serum/Plasma: 1,500 - 30,000 U/L

Nonclinical testing demonstrates that this device is as safe and effective as the predicate device.

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Prepared by:

Kenneth T. Edds, Ph.D.
Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591

On: January 15, 2002

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 8 2002

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Diagnostic Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k013750 Trade/Device Name: Cholinesterase Assay for the Advia 1650 Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase Test System Regulatory Class: Class I Product Code: DIH Dated: November 12, 2001 Received: November 13, 2001

Dear Dr. Edds:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 1 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 premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: KO13750

Device Name: Cholinesterase Assay for the Advia 1650

#### Indications for Use:

The ADVIA 1650 Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase in human I he ADVANT 1050 Onlinesser any and 650 system. Such measurement is used in the diagnosis and treatment Scruit and pashia on the Dayer AD Previous liver diseases such as cirrhosis and acute and chronic hepatitis.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013750

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-CounterUse___________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)