UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator

K142985 · Beckman Coulter, Inc. · JIT · Feb 26, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142985
• Device Name: UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
• Applicant: Beckman Coulter, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Olympus HDL Cholesterol Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Olympus AU400/AU600/AU2700/AU5400 and UniCel DxC 600/800 SYNCHRON systems.

Device Story

The UniCel DxC SYNCHRON Systems HDL Cholesterol reagent and calibrator are used with Beckman Coulter UniCel DxC 600/800 clinical chemistry analyzers. The system measures HDL cholesterol levels in human serum or plasma samples. The device is intended for professional use in clinical laboratory settings. By providing quantitative measurements of HDL cholesterol, the system assists clinicians in diagnosing and managing lipid disorders, atherosclerosis, and associated liver or renal conditions. The calibrator ensures accurate system performance by providing standardized calibration levels for the reagent assay.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the reagent and calibrator system.

Technological Characteristics

In vitro diagnostic reagent; colorimetric assay. Wavelength: 560 nm. Measuring interval: 5-135 mg/dL. Compatible with UniCel DxC 600/800 SYNCHRON and Olympus AU series systems. Reagent bottle shape modified.

Indications for Use

Indicated for quantitative determination of HDL-C in human serum and plasma for clinical diagnostic use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2015

BECKMAN COULTER, INC. C/O EIMEAR CARR REGULATORY AFFAIRS SPECIALIST 250 S. KREAMER BOULEVARD BREA CA 92821

Re: K142985

Trade/Device Name: UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent (HDL) Unicel Dxc SYNCHRON Systems HDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, LBS Dated: January 23, 2015 Received: January 27, 2015

Dear Eimear Carr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -A

For :Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL) UniCel DxC SYNCHRON Systems HDL Calibrator

## Indications for Use (Describe)

Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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