UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

K103842 · Beckman Coulter, Inc. · CGA · Apr 27, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103842
• Device Name: UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
• Applicant: Beckman Coulter, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The UniCel DxC 800 System Software Version 5.0 is a fully automated, computercontrolled clinical chemistry analyzers intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose. GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Device Story

UniCel DxC 800 SYNCHRON System is a fully automated, computer-controlled clinical chemistry analyzer for in vitro diagnostic testing. It processes human serum, plasma, urine, or CSF samples. The system utilizes an oxygen rate electrode method where samples are injected into a reaction cup containing glucose oxidase; the peak rate of oxygen consumption is measured, which is directly proportional to glucose concentration. The system features bar code identification, closed tube sampling, and obstruction detection. It is operated by laboratory personnel in a clinical setting. Software version 5.0 introduces USB data storage, network printer support, patient name-based result retrieval, and modified stirrer bar operation during reagent fill. Output is provided as quantitative glucose concentration values, which clinicians use to diagnose and manage carbohydrate metabolism disorders.

Clinical Evidence

Bench testing only. Validation testing performed on a representative chemistry menu to demonstrate performance characteristics equivalent to predicate systems.

Technological Characteristics

Fully automated clinical chemistry analyzer; oxygen rate electrode sensing principle; random access operation. Software version 5.0 runs on QNX 6.4 operating system. Connectivity includes USB and network printing. System components include bar code readers, modular chemistry sections, and reagent storage. Sterilization is not applicable to the software/instrument system.

Indications for Use

Indicated for patients requiring glucose concentration determination in serum, plasma, urine, or CSF to diagnose/treat carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• UniCel® DxC 600/800 SYNCHRON® System Software Version(s) 1.0 (K042291)
• UniCel® DxC 600/800 SYNCHRON® System Software Version(s) 1.4 (K060256)

Submission Summary (Full Text)

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K103842

# 510(k) Summary UniCel® DxC SYNCHRON® Clinical Systems Software Version 5.0

# 1.0 Submitted By:

Marine Boyajian Senior Requlatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd. Mail Code: E2.SE.08 Brea, CA 92821 Telephone: [phone] Fax: [phone]

APR 2 7 2011

# 2.0 Date Submitted

December 29, 2010

#### 3.0 Device Name(s):

- 3.1 Proprietary Names UniCel® DxC 800 SYNCHRON® System Software Version 5.0
#### 3.2 Classification Name

Discrete photometric chemistry analyzer for clinical use [862.2160] 21CFR Sec.- 862.1345 Glucose test system

#### 4.0 Legally Marketed Device

| Candidate(s) | Predicate | Manufacturer | Document<br>Number |
|-------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------|---------------------|
| UniCel® DxC 800<br>SYNCHRON® System<br>Software Version 5.0 | UniCel® DxC 600/800<br>SYNCHRON® System<br>Software Version(s)<br>1.0 and 1.4 | Beckman Coulter,<br>Inc. | K042291,<br>K060256 |

The UniCel® DxC 800 SYNCHRON® System Software Version 5.0 claim substantial equivalence to the UniCel® DxC 600/800 SYNCHRON® System Software Version(s) 1.0 (Docket Number K042291) and 1.4 (Docket Number K060256), currently in commercial distribution.

#### 5.0 Device Description

The UniCel® DxC 800 SYNCHRON® System equipped with Software Version 5.0 is member of the SYNCHRON family of clinical chemistry analyzers, manufactured and distributed by Beckman Coulter, Inc. The SYNCHRON instrument family includes the SYNCHRON CX Clinical Chemistry Systems (CX4/CE/Δ/PRO, CX5/CEIA/PRO. CX7/RTS/&/PRO, CX9ALX/PRO), and the SYNCHRON LX Clinical Chemistry Systems (LX20/PRO/LXi 725). The UniCel DxC Systems are distinquished from other SYNCHRON systems in that they utilize more advanced hardware and software to improve system robustness and serviceability, and offer enhancements and features for user convenience. The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with SYNCHRON Systems.

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# 6.0 Intended Use

The UniCel DxC 800 System Software Version 5.0 is a fully automated, computercontrolled clinical chemistry analyzers intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose.

GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

## 7.0 Comparison to the Predicate

In this submission, Beckman is seeking clearance for the UniCel DxC 800 System equipped with Software Version 5.0.

To demonstrate substantial equivalence, the notification centers on a comparison of software and hardware to the predicate UniCel DxC 600/800 platforms, and demonstrates performance characteristics of a representative chemistry menu. Selected reagent test systems will demonstrate that both the module chemistry (MC) and the cartridge chemistry (CC) section of the UniCel DxC Software Version 5.0 Systems provide equivalent performance to that of current UniCel DxC Systems.

## 8.0 Summary of Performance Data

Performance data from validation testing (provided in the "Performance Characteristics" section of this submission) supports equivalency.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is simple and straightforward, with a focus on the text.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

**APR 27 2011**

Beckman Coulter, Inc. c/o Marine Boyajian Senior Regulatory Affairs Specialist 250 S. Kraemer Boulevard, Mail Stop E2 Se08 Brea, CA 92821

Re: k103842

Trade/Device Name: UniCel DxC 800 Synchron System Software Version 5.0 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II, I Product Code: CGA, JJE Dated: March 30, 2011 Received: March 31, 2011

Dear: Marine Boyajian:

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 predicated evices 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 adulters, goo

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 administering 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) { 1 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parts 801 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 toon the
[phone] or [phone] or at its International and Consumer at its toll-free [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

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

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Enclosure

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# Indication for Use

510(k) Number (if known): K103842

Device Name: UniCel® DxC 800 SYNCHRON® Clinical System Software Version 5.0

Indication For Use:

The UniCel DxC 800 System Software Version 5.0 is a fully automated, computercontrolled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose.

GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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 (OIVD)

Division Sign Off

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

510(k) K103842