VITROS CHEMISTRY PRODUCTS DHDL SLIDES

K120609 · Ortho-Clinical Diagnostics, Inc. · LBS · Sep 7, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120609
• Device Name: VITROS CHEMISTRY PRODUCTS DHDL SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.

Device Story

VITROS Chemistry Products dHDL Slides; in vitro diagnostic device for quantitative HDL-C measurement in serum/plasma. Modification involves reduced slide surface area and proportional reduction in reagent amounts per test; reduced sample volume requirement. Operates on VITROS Chemistry Systems; used in clinical laboratory settings by trained personnel. Output provides HDL-C concentration values to assist clinicians in lipid profile assessment and cardiovascular risk evaluation. Modification maintains fundamental scientific technology of predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing demonstrating that the modified slide performs equivalently to the predicate despite the reduction in sample volume and slide surface area.

Technological Characteristics

In vitro diagnostic slide-based assay; colorimetric/enzymatic detection principle. Modification: reduced slide surface area and proportional reagent volume adjustment. Compatible with VITROS Chemistry Systems.

Indications for Use

Indicated for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma.

Regulatory Classification

Identification

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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• VITROS Chemistry Products dHDL Slides (k042006)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k120609

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) for the VITROS Chemistry Products dHDL Slide:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: Ortho Clinical Diagnostics, VITROS Chemistry Products dHDL Slides (k042006).

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 the VITROS dHDL Slides:

1) Change in the amount of ingredients per test due to reduction in slide surface area. The change in the amount of reagents in is proportional for all ingredients due to reduced slide surface area.
2) Reduction in sample volume required per test.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.