VITROS CHEMISTRY PRODUCTS TRIG SLIDES

K130332 · Ortho-Clinical Diagnostics, Inc. · CDT · May 31, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130332
• Device Name: VITROS CHEMISTRY PRODUCTS TRIG SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Indications for Use

For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Device Story

VITROS Chemistry Products TRIG Slides are in vitro diagnostic test slides used on VITROS Chemistry Systems. The device utilizes an enzymatic endpoint reaction to measure triglyceride concentration in serum or plasma samples. The process involves lipase, glycerol kinase, and L-alpha-glycerophosphate oxidase to catalyze reactions, followed by reflectance spectrophotometry to quantify the analyte. The system is operated by laboratory professionals in clinical settings. The output provides quantitative triglyceride levels, which clinicians use to diagnose and monitor metabolic, endocrine, and lipid-related diseases. The device is a modified version of a previously cleared product, maintaining identical technological principles and performance characteristics.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance criteria met following reagent enzyme source change.

Technological Characteristics

In vitro diagnostic lipase assay reagent. Modification: enzyme source changed from Candida Rugosa to Pseudomonas. Fundamental scientific technology unchanged.

Indications for Use

Indicated for patients requiring quantitative measurement of triglyceride concentration in serum or plasma to assist in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, or endocrine disorders.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K130332

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.)

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 change to the lipase component of the assay from Candida Rugosa to Pseudomonas.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, test principle, procedure and range as well as enzyme (reagent) biological source.

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.