AMM

K981467 · Abbott Laboratories · JIF · Jun 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981467
• Device Name: AMM
• Applicant: Abbott Laboratories
• Product Code: JIF · Clinical Chemistry
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Device Story

The Ammonia assay is an in vitro diagnostic clinical chemistry test for human plasma. It utilizes an enzymatic reaction where glutamate dehydrogenase (GLDH) catalyzes the amination of alpha-ketoglutarate by ammonia, coupled with the oxidation of NADH. This reaction produces a decrease in absorbance at 340 nm, which is measured by an automated analyzer (e.g., ALCYON Analyzer). The magnitude of absorbance decrease is directly proportional to the ammonia concentration in the sample. The assay is intended for use by clinical laboratory professionals to provide quantitative results that assist physicians in diagnosing and managing liver-related pathologies. The output is a numerical concentration value (µmol/L) used to inform clinical decision-making regarding liver function.

Clinical Evidence

Bench testing only. Method comparison study performed on the ALCYON Analyzer against the Roche Cobas Mira Plus system (n not specified). Results: correlation coefficient = 0.9969, slope = 1.044, Y-intercept = 12.020 µmol/L. Precision studies (within-run, between-run, between-day) showed total %CVs of 13.8% (Level 1), 5.2% (Level 2), and 3.0% (Level 3). Linearity established up to 630 µmol/L; limit of quantitation (sensitivity) is 19 µmol/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Enzymatic (glutamate dehydrogenase) kinetic spectrophotometric measurement at 340 nm. Reagents: alpha-ketoglutarate, NADH, GLDH. Form factor: Liquid reagent for use on automated clinical chemistry analyzers. Connectivity: Dependent on host analyzer system. Sterilization: Not applicable (reagent).

Indications for Use

Indicated for the quantitative determination of ammonia in human plasma to aid in the diagnosis and treatment of severe liver disorders, including cirrhosis, 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

• Roche Cobas Mira Plus Automated Chemistry System Ammonia assay (K914750)

Submission Summary (Full Text)

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K981467

JUN 222 1998

# 510(k) Summary

# Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs [phone] Fax [phone]

April 22, 1998 Date of Preparation of this Summary: Device Trade or Proprietary Name: Amm Device Common/Usual Name or Classification Name: Ammonia Classification Number/Class: 75JIX/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:

# Test Description:

Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NH2DPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NHzDP*. The oxidation of NHzDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.

### Substantial Equivalence:

The Ammonia assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Ammonia assay (K914750).

Ammonia 510(k) April 22, 1998 Ammf.lwp

Section II Page 1

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Both assays vield similar Performance Characteristics.

Similarities:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of ammonia. .
- Both assays yield similar clinical results. .

#### Differences:

- There is a minor difference between assay range. .
#### Intended Use:

The Ammonia assay is used for the quantitation of ammonia in human plasma.

### Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Ammonia assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay. The correlation coefficient = 0.9969, slope = 1.044, and Y-intercept = 12.020 umol/L. Precision studies were conducted using the Ammonia assay. Within-run, between-run, and between-day studies were performed using three levels of control material. The total %CV for Level 1/Panel 121 is 13.8%, 5.2% for Level 2/Panel 122, and 3.0% for Level 3/Panel 123. The Ammonia assay is linear up to 630 µmol/L. The limit of quantitation (sensitivity) of the Ammonia assay is 19 umol/L. These data demonstrate that the performance of the Ammonia assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay.

# Conclusion:

The Ammonia assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay as demonstrated by results obtained in the studies.

Ammonia 510(k) April 22, 1998 Ammf.lwp

Section II Page 2

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JUN 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K981467 AMM Requlatory Class: I Product Code: JIF Dated: April 22, 1998 Received: April 23, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set--forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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 (if known):

Ammonia ______________________________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Nurnber `k981467

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurpence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)