AU5800(R) CHEMISTRY ANALYZER

K112412 · Beckman Coulter, Inc. · CEM · Dec 23, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112412
• Device Name: AU5800(R) CHEMISTRY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode. The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Potassium test system is for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Device Story

Fully automated, random access clinical chemistry analyzer for ultra-high throughput laboratories; available in configurations from one to four photometric modules. Inputs: serum, plasma, urine, or other body fluids. Operation: automated analysis using colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, or ion selective electrode (ISE) methods. System uses reagents, calibrators, and QC materials common to the AU series. Output: quantitative analyte results generated automatically. Used by laboratory technicians/staff to monitor patient health, diagnose metabolic disorders, and manage electrolyte balance. Benefits: high-throughput processing, reliable results, and standardized reference ranges across the AU family.

Clinical Evidence

Bench testing only. Performance validated through linearity, precision, method comparison, sensitivity, and interference studies using representative assays from the AU chemistry menu. Equivalence demonstrated by comparing performance data between the AU5800 and the AU2700 predicate platform.

Technological Characteristics

Fully automated, random access photometric analyzer. Uses halogen lamp (340-800 nm) and ISE for electrolyte measurement. Glass cuvettes (500 uL capacity, 5mm light path). Modular design (1-4 modules). Connectivity: automated barcode sample recognition. Reagent capacity: 54 bottles per reagent position. Software-controlled automated analysis.

Indications for Use

Indicated for quantitative measurement of analytes (e.g., glucose, magnesium, potassium) in human serum, plasma, urine, and cerebrospinal fluid to aid in diagnosis and treatment of metabolic disorders, electrolyte imbalances, and related conditions. For prescription use in clinical laboratory settings.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• AU2700 Clinical Chemistry Analyzer (K002982)

Submission Summary (Full Text)

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K112412

DEC 2 3 2011

## 510(k) Summary AU5800 Clinical Chemistry Analyzer

#### 1.0 Submitted By:

David G. Davis Group Manager, Regulatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Blvd. Mail Code: E2 SE.08 Brea, CA 92821 Telephone: [phone] Fax: [phone]

#### 2.0 Date Submitted

August 19, 2011

#### 3.0 Device Name(s):

- 3.1 Proprietary Names AU5800 Clinical Chemistry Analyzer
#### 3.2 Classification Name

Discrete photometric chemistry analyzer for clinical use [862.2160]

#### 4.0 Legally Marketed Device

| Candidate(s) | Predicate | Manufacturer | Document<br>Number |
|---------------------------------------|---------------------------------------|--------------------------|--------------------|
| AU5800 Clinical<br>Chemistry Analyzer | AU2700 Clinical<br>Chemistry Analyzer | Beckman Coulter,<br>Inc. | K002982 |

The AU5800 Clinical Chemistry Analyzer is substantial equivalence to the AU2700 Clinical Chemistry Analyzer (Docket Number K002982), currently in commercial distribution.

#### Device Description 5.0

The AU5800 clinical chemistry analyzer is a fully automated, random access analyzer, designed for ultra-high throughput laboratories. This system is designed to suit varying workloads and is available in different configurations, from a one-single photometric module AU5810, up to a four-photometric module AU5840. The AU5800 analyzer measures analytes in samples using the same reagents, calibrators, quality control (QC) materials and other consumables used within the AU series of instruments. This ensures the same reliable results and references ranges across the AU family members. This system carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. Electrolyte measurement is performed using a single or double cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

#### 6.0 Intended Use

The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro

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diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

#### 7.0 Comparison to the Predicate

The AU5800 Clinical Chemistry System is a family member of the AU series of analyzers, The AU2700 (K002982) to which the substantial equivalence comparison is claimed. The devices have same / similar design and modes of operation. The key features are summarized in the following table.

| | Predicate Device: | Proposed Device: |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | AU2700 Clinical Chemistry System | AU5800 Clinical Chemistry Analyzer |
| Intended Use: | The Olympus AU2700 Clinical<br>Chemistry Analyzer is a fully<br>automated photometric analyzer<br>intended for clinical laboratory use.<br>Applications include colorimetric,<br>Turbidimetric, latex agglutination, and<br>homogeneous enzyme immunoassay. | The Beckman Coulter AU5800<br>Clinical Chemistry Analyzer is an<br>automated chemistry analyzer that<br>measures analytes in samples, in<br>combination with appropriate<br>reagents, calibrators, quality control<br>(QC) material and other accessories.<br>This system is for in vitro diagnostic<br>use only. Applications include<br>colorimetric, turbidimetric, latex<br>agglutination, homogeneous enzyme<br>immunoassay, and ion selective electrode. |
| Methodology: | Analyzer, chemistry (photometric,<br>discrete), for clinical use has been<br>classified as Class I, JJE by the<br>Clinical Chemistry and Clinical<br>Toxicology Devices Panel, (21 CFR<br>862.2160). | Same as AU2700 |
| Sample Types: | Blood serum, urine, CSF, or Plasma | Same as AU2700 |
| Assay Type: | End Point, Kinetic, Ions Selective<br>Electrode (ISE) Optional.<br>Applications:<br>Colorimetric, Turbidimetric, Latex<br>Agglutination, Homogenous EIA. | Same as AU2700 |
| Reactant<br>Volume: | 120μl to 430μl | 80μl to 287μl |
| Sample Volume | 1.6uL to 25.0 uL | 1.0 to 17.0 uL |
| Prevention of<br>Sample Carry<br>Over | Deionized Water Wash with<br>Contamination Avoidance<br>Parameters and enhanced washing<br>sequence | Same as AU2700<br>New function: extra optional DI wash<br>sequence |
| Recognition of<br>Sample | Read from the barcode | Same as AU2700 |
| Reagent On-<br>board chemistries | Reagent 1 - 48 bottle capacity<br>Reagent 2 - 48 bottle capacity | Reagent 1 - 54 bottle capacity<br>Reagent 2 - 54 bottle capacity |
| Reagent Bottle | Reagent bottles with a capacity of<br>15mL, 30 mL, 60 mL, 120mL, 180mL | Same as AU2700 |
| Reagent Volume | 15 to 250 µL (can be set by 1uL) | 10 to 170 µL (can be set by 1uL) |
| Normal<br>Pipette | 15 to 250 µL (can be set by 1uL) | 10 to 170 µL (can be set by 1uL) |
| Feature | Predicate Device:<br>AU2700 Clinical Chemistry System | Proposed Device:<br>AU5800 Clinical Chemistry Analyzer |
| Diluent<br>Volume | 0,10 to 235 uL (can be set by 1uL)<br>Max (reagent+diluent) less than 250uL | 0,10 to 160 uL (can be set by 1uL)<br>Max (reagent+diluent) less than 170uL |
| Wave length (nm) | Halogen Lamp<br>340 to 800 nm<br>13 wavelengths: 340, 380, 410, 450, 480, 520, 540, 570, 600, 660, 700, 750 and 800 nm | Same as AU2700 |
| Cuvette | Square, glass cuvette<br>6x5 mm (Inside)<br>Capacity: 750 uL<br>Light Path: 6mm | Square, glass cuvette<br>4 x 5 mm (Inside)<br>Capacity: 500 uL<br>Light Path: 5mm |
| Cycle time of<br>photometry<br>measuring point | 28 points in 8.5 minutes (±.5 min) | Same as AU2700 |

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### Comparison testing

In order to further demonstrate the comparability of the Beckman AU2700 and the proposed new Beckman Coulter AU5800, the following reagent performance testing was performed on a representative number of assays:

Linearity Precision Method Comparison Sensitivity Interference Reference Range

The AU5800 chemistry analyzer uses same lon Selectrode (ISE) and reagents, as well as the same menu of reagents currently available on the AU2700. Representative assays from the AU chemistry menu were selected to demonstrate equivalency between the proposed AU5800 and the predicate device. The studies were selected from reviewing the applicable sections of FDA's eSubmitter software tool for instrument only submissions and utilizing the FDA's Guidance for Industry and FDA staff Replacement Reagent and Instrument Family Policy.

The remaining reagent application validations not presented within the 510(k) will be validated using risk management, design controls, and the principles from FDA's Guidance for Industry and FDA staff Replacement Reagent and Instrument Family Policy. The core validation principles are linearity, control/standard recovery, method comparison, precision, sensitivity, interference, prozone tolerance and onboard/calibration frequency studies. Reference ranges will be verified, where appropriate. No reagent application will be released to the market without the satisfactory completion of the validation process.

#### 8.0 Summary of Performance Data

The submission provides the data necessary to demonstrate this equivalence based on the performance validations and comparisons conducted between the representative reagents and analyzer platforms. Based on this data, the new AU5800 Chemistry Analyzer is substantially equivalent to the referenced predicate(s).

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# Traceability

The traceability information in the reagent 510ks was updated via K043460 on the calibrator to align with the current IFU claims.

| Predicate Reagent 510k(s) | Calibrator 510(k) | Current IFU claim |
|---------------------------|------------------------------|--------------------------|
| Glucose traceability | Glucose traceability | Glucose traceability |
| NIST SRM 916a | NIST SRM 965a | NIST SRM 965a |
| Magnesium traceability | Magnesium traceability | Magnesium traceability |
| NIST SRM 909a-2 | NIST SRM 909b | NIST SRM 909b |
| Potassium traceability | Not impacted by modification | Potassium traceability |
| Not specified - but | | Not specified - but |
| gravimetrically prepared | | gravimetrically prepared |
| standard | | standard |

The on-board claims were re-assessed on the AU2700 analyzer 510k, which is the predicate for the AU5800. In addition, the potassium on board claims were expanded through the design control process.

| Predicate Reagent 510(k) | AU2700 Instrument K003721 | Current IFU |
|------------------------------|------------------------------|------------------------------|
| Glucose on-board stability | Glucose on-board stability | Glucose on-board stability |
| 14 days | 30 days | 30 days |
| Magnesium on-board stability | Magnesium on-board stability | Magnesium on-board stability |
| 30 days | 7 days | 7 days |
| Potassium on-board stability | Not mentioned in submission | Potassium on-board stability |
| 30 days | | 90 days |

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Image /page/4/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 a stylized graphic of what appears to be an abstract human form or a symbol representing human services.

10903 New Hampshire Avenue Silver Spring, MD 20993

Beckman Coulter, Inc. c/o David G. Davis 250 S. Kraemer Blvd. Mail Code: E2.SE.08 Brea, CA 92821

DEC 2 3 2011

Re: K112412 Trade name:

AU5800 Clinical Chemistry Analyzer

Regulation Number: 21 CFR §862.1345 Glucose test system Regulation Name: Regulatory Class: Class II Product Codes: CFR, CEM, JGJ, JJE Dated: November 11, 2011 Received: November 14, 2011

Dear Mr. Davis.

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (k112412):

Device Name: AU5800 Clinical Chemistry Analyzer

Indication For Use:

The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Potassium test system is for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112412