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

Indications for 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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SPECIAL 510(k): Device Modification

ODE Review Summary (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: K142985

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K040692, Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol Calibrator ODC0023

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

1. Expanding the use of the reagent on the UniCel DxC 600/800 SYNCHRON systems
a. Change measuring wavelength from 600 nm to 560 nm.
b. Change in the measuring interval of the assay from 2.25-200 mg/dL to 5-135 mg/dL.
c. Removing EDTA plasma as a sample matrix.
2. Change in shape of the reagent bottle.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and performance characteristics. Studies performed include method comparison, linearity, stability studies including shelf-life and open vial stability, interference, analytical sensitivity, and matrix comparison.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.