AMMONIA ASSAY FOR THE ADVIA 1650

K023841 · Bayer Diagnostics Corp. · JIF · Dec 24, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023841
• Device Name: AMMONIA ASSAY FOR THE ADVIA 1650
• Applicant: Bayer Diagnostics Corp.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Dec 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

Device Story

Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic reagent and calibrator system. It measures ammonia levels in human plasma (heparin or EDTA) samples. The device operates on the ADVIA 1650 clinical chemistry analyzer. It provides quantitative results used by clinicians to assess hepatic function and aid in the diagnosis of Reye's syndrome. The system is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies and method correlation against the Roche Ammonia system. Correlation study (N=94) showed r=0.98 across a range of 26-1174 µg/dL. Interfering substances (hemoglobin, bilirubin, Intralipid, triglycerides) were tested for recovery impact.

Technological Characteristics

In vitro diagnostic chemical assay for use on the ADVIA 1650 analyzer. Quantitative measurement of ammonia in plasma. Analytical range: 25 to 1300 µg/dL.

Indications for Use

Indicated for quantitative measurement of ammonia in human plasma (heparin or EDTA) to assess hepatic function and diagnose 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

• Roche Ammonia (Reagent Part #1877984, Calibrator Part #166570)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ammonia method for ADVIA® 1650TM

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: K 0 2 3 8 4/

## 1. Intended Use

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

## 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|---------------|----------------|-------------------|
| Roche Ammonia | 1877984 | 166570 |

# 3. Device / Method

| Product Name | Reagent Part # | Calibrator Part # |
|----------------------------|----------------|-------------------|
| Bayer ADVIA® 1650™ Ammonia | B01-4822-01 | B03-4827-01 |

#### Imprecision

| ADVIA 1650 | | Roche | |
|------------------|-------------------------|------------------|-------------------------|
| Level<br>(ug/dL) | Within-<br>run<br>CV(%) | Level<br>(ug/dL) | Within-<br>run<br>CV(%) |
| 69.7 | 3.8 | 67.5 | 3.9 |
| 150.6 | 1.7 | 496.8 | 0.7 |
| 387.9 | 0.7 | 574.8 | 7.33 |

#### Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen<br>Type | Comparison<br>System (x) | N | Regression<br>Equation | Syx | r | Sample Range<br>µg/dL |
|------------------|--------------------------|----|------------------------|-------|------|-----------------------|
| Plasma | Roche<br>(On Hitachi) | 94 | $Y = 1.05x + 7.19$ | 62.18 | 0.98 | 26 - 1174 |

#### Interfering Substances

| METHOD | Sample<br>Concentration | Interferent | Interferent<br>Concentration<br>(mg/dL) | Sample+Interferent<br>Concentration | Recovery<br>% |
|---------|-------------------------|------------------|-----------------------------------------|-------------------------------------|---------------|
| Ammonia | 179.28 | hemoglobin | 250 | 188.57 | 105.18% |
| | 176.71 | bilirubin conj | 18.75 | 168.4 | 95.30% |
| | 168.25 | bilirubin unconj | 25 | 169.05 | 100.48% |
| | 214.24 | Intralipid | 62.5 | 195.08 | 91.06% |
| | 187.56 | TRIG Concentrate | 62.5 | 204.4 | 108.98% |

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Analytical Range Serum/Plasma(Lithium heparin):

。

25 to 1300 ug/dL

Sa Si Parc, Andres Holle

11-/15-02

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Date

Date

Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 24 2002

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re:

k023841 Trade/Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650 Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class II Product Code: JIF; JIT Dated: November 15, 2002 Received: November 18, 2002

Dear Mr. Holle:

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. Iisting 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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# Page 2

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). 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 Autman

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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Page

#### K023841 510(k) Number:

Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650™

### Indications for Use:

The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.

tean

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023841

(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)