AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K021151 · Bayer Diagnostics Corp. · JIF · Jul 13, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021151
• Device Name: AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
• Applicant: Bayer Diagnostics Corp.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Jul 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

Device Story

The Bayer ADVIA IMS Ammonia assay is an in vitro diagnostic reagent system used on the ADVIA IMS analyzer. It measures ammonia concentration in human plasma (K3EDTA) samples. The device provides quantitative results used by clinicians to assist in diagnosing and managing hepatic conditions like cirrhosis and Reye's syndrome. The assay is intended for professional use in clinical laboratory settings. Performance is validated through correlation with predicate systems and assessment of analytical range and interference profiles.

Clinical Evidence

Bench testing only. Correlation study performed against Sigma/Fara II system (N=51, R=0.998, Y=0.93X+14.8). Analytical range established at 5-500 umol/L. Interference testing conducted for bilirubin, hemoglobin, and lipids; results show minor percentage changes in ammonia concentration at 100 umol/L.

Technological Characteristics

In vitro diagnostic reagent assay for use on the ADVIA IMS analyzer. Analytical range: 5-500 umol/L. Sample type: K3EDTA plasma. Methodology involves chemical measurement of ammonia. No specific software algorithm or material standards provided.

Indications for Use

Indicated for measuring ammonia levels in human plasma to aid in the diagnosis and treatment of hepatic diseases including cirrhosis, hepatic failure, hepatitis, and Reye's syndrome.

Regulatory Classification

Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Predicate Devices

• Sigma Ammonia (K760332)

Submission Summary (Full Text)

{0}------------------------------------------------

## 'JUL 1 3 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ammonia method for ADVIA® IMSTM

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:

#### 1. Intended Use

The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

### 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|---------------|----------------|-------------------|
| Sigma Ammonia | 171-C | 171-C |

#### 3. Device / Method

| Product Name | Reagent BAN | Calibrator BAN |
|---------------------------|-------------|----------------|
| Bayer ADVIA® IMS™ Ammonia | 04454764 | 08648547 |

#### Imprecision

| ADVIA IMS | | Sigma | |
|-------------------|----------------|-------------------|----------------|
| Level<br>(umol/L) | Total<br>CV(%) | Level<br>(umol/L) | Total<br>CV(%) |
| 21.4 | 15.8 | 52.9 | 4.2 |
| 112 | 3.5 | 323 | 1.7 |
| 234 | 4.3 | 490 | 1.8 |

#### Correlation (Y=ADVIA IMS, X=comparison system)

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (umol/L) | R | Sample Range (umol/L) |
|-----------------|-----------------------|----|---------------------|--------------|-------|-----------------------|
| Plasma (K3EDTA) | Sigma/Fara II | 51 | Y=0.93X+14.8 | 9.7 | 0.998 | 13.0 to 500 |

#### Interfering Substances

| Interfering | Interfering Sub. | Ammonia Conc | Effect |
|--------------------------|------------------|--------------|------------|
| Substance | Conc. (mg/dL) | (umol/L) | (% change) |
| Bilirubin (unconjugated) | 18.8 | 100 | -8.0 |
| Bilirubin (conjugated) | 25 | 100 | +3.0 |
| Hemoglobin | 500 | 100 | +11.0 |
| Lipids (Triglycerides) | 500 | 100 | -12.0 |

#### Analytical Range

Plasma: 5 - 500 umol/L

{1}------------------------------------------------

## 4. Conclusion

Performance for the ADVIA IMS Ammonia Assay on the Bayer ADVIA® IMS™ is equivalent to the performance of the Ammonia Assay on the predicate device (Sigma, K760332) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.

Semuel Halls

4/8/02
Date

Date

Kenneth T. Edds Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# IJUL 1 3 2002

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

Re: k021151

> Trade/Device Name: Ammonia Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I, reserved Product Code: JIF Dated: June 26, 2002 Received: June 27, 2002

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

. 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 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 Butman

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

{4}------------------------------------------------

Page 1 of 1

510(k) Number: K021151

Device Name: Ammonia Assay for the ADVIA® IMSTM

#### Indications for Use:

The Bayer ADVIA IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

(Division Sign-Off)

Cooper
Division of Clinical Laboratory Dévices
510(k) Number K021151

(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-CounterUse

(Optional Format 1-2-96)