SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT

K984402 · Beckman Coulter, Inc. · JIF · Jan 29, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984402
• Device Name: SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

Device Story

SYNCHRON Systems Ammonia (AMM) Reagent is an in vitro diagnostic reagent for use on Beckman Coulter SYNCHRON CX and LX clinical chemistry analyzers. The device utilizes a glutamate dehydrogenase (GLDH) enzymatic method to measure ammonia concentration in human plasma samples. The reagent is provided in a ready-to-load liquid format, requiring no user preparation. The analyzer performs a timed endpoint assay at 37°C. Healthcare professionals in clinical laboratory settings use the resulting quantitative ammonia measurements to assist in diagnosing and monitoring liver conditions such as cirrhosis, hepatitis, and Reye's syndrome. The system automates sample processing, reducing required sample volume compared to older tablet-based predicate methods.

Clinical Evidence

Bench testing only. Method comparison studies (n=82) against the predicate method showed high correlation for both SYNCHRON CX (slope 1.018, r=0.9991) and LX (slope 1.003, r=0.9986) systems. Within-run imprecision studies (n=15 per level) demonstrated %C.V. ranging from 0.8% to 4.9% across three concentration levels (48–644 µmol/L) on both systems.

Technological Characteristics

Enzymatic assay using glutamate dehydrogenase (GLDH) from beef liver. Liquid reagent format. Designed for automated clinical chemistry analyzers (SYNCHRON CX/LX). Measures ammonia via timed endpoint spectrophotometry at 37°C.

Indications for Use

Indicated for the quantitative determination of ammonia concentration in 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

• Ammonia reagent on the Dade aca® clinical analyzer (K770363)

Submission Summary (Full Text)

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JAN 29 1999

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Summary of Safety & Effectiveness SYNCHRON® Systems Ammonia (AMM) Reagent

- 1.0 Submitted By:
Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

## 2.0 Date Submitted:

December 7, 1998

## 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Ammonia (AMM) Reagent

# 3.2 Classification Name

Ammonia (21CFR §862.1065)

# 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------------|-----------------------------------------------------------|-------------------|------------------|
| SYNCHRON®<br>Systems Ammonia<br>(AMM) | Ammonia reagent on the<br>Dade aca®* clinical<br>analyzer | Dade Behring, Inc | K770363 |

*Trademark of Dade Behring Inc. - formerly DuPont

## 5.0 Description:

The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.

Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: [phone] [phone] Facsimile: Internet: www.beckmancoulter.com

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Ammonia (AMM) Reagent Summary of Safety & Effectiveness

#### 6.0 Intended Use:

The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

#### 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| | SIMILARITIES | |
|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON®<br>Systems<br>Ammonia | SYNCHRON assay uses GLDH<br>enzymatic method for measuring<br>ammonia at 37°C. | Same as Dada aca Reagent |
| | GLDH source is beef liver | |
| | The reagent is ready to load onto the<br>instrument (requires no user preparation). | |
| | Reagent measures ammonia in human<br>plasma. | |
| | DIFFERENCES | |
| | Reagent components | All components of the SYNCHRON<br>Ammonia reagent are liquid<br>Some components of the Dade aca<br>Ammonia reagent are in tablets and<br>others are liquid. |
| | Sample Volume | SYNCHRON Ammonia assay<br>requires 25 µL of sample.<br>aca assay requires 500 µL of<br>sample. |
| | Type of measurement | SYNCHRON Ammonia is a timed<br>endpoint assay.<br>Dade aca is a rate assay. |

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, and imprecision experiments.

| SYNCHRON<br>DIGN Reagent | Sample<br>Type | Slope | Intercept<br>(μmol/L) | r | n | Predicate<br>Method |
|--------------------------|----------------|-------|-----------------------|--------|----|---------------------|
| SYNCHRON<br>CX System | Plasma | 1.018 | -5.3 | 0.9991 | 82 | Dade aca |
| SYNCHRON LX<br>System | Plasma | 1.003 | -2.2 | 0.9986 | 82 | Dade aca |

Method Comparison Study Results SYNCHRON® Systems Digoxin (DIGN) Reagent

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| SYNCHRON System | Sample | Mean (µmol/L) | S.D. (µmol/L) | %C.V. | N |
|-----------------|---------|---------------|---------------|-------|----|
| CX | Level 1 | 48 | 2.6 | 4.2 | 15 |
| | Level 2 | 128 | 3.0 | 2.3 | 15 |
| | Level 3 | 644 | 5.3 | 0.8 | 15 |
| LX | Level 1 | 48 | 2.3 | 4.9 | 15 |
| | Level 2 | 128 | 2.8 | 2.2 | 15 |
| | Level 3 | 644 | 4.9 | 0.8 | 15 |

Estimated Within-Run Imprecision

.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Public Health Service

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JAN 29 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lucinda Stockert Staff Regulatory Specialist, Product Submissions BECKMAN COULTER, INC. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000

K984402 Re: Trade Name: SYNCHRON® Systems Ammonia (AMM) Reagent Regulatory Class: I Product Code: JIF December 7, 1998 Dated: December 9, 1998 Received:

Dear Ms. Stockert:

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 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). 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 (Premarket Approval), 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 895. A 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 regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 requlations.

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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/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

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page | of |

K984402 510(k) Number (if known):

Device Name: SYNCHRON® Systems

Ammonia (AMM) Reagent

Indications for Use:

The SYNCHRQN® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

Clinical Significance:

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.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984402

(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-Counter Use Optional Format 1-2-96

(