VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · Ortho-Clinical Diagnostics, Inc. · JJE · Nov 13, 2006 · Clinical Chemistry
Device Facts
Record ID
K063144
Device Name
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
Product Code
JJE · Clinical Chemistry
Decision Date
Nov 13, 2006
Decision
SESE
Submission Type
Special
Regulation
21 CFR 862.2160
Device Class
Class 1
Indications for Use
The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma. The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Device Story
The VITROS Chemistry Products dHDL assay utilizes a reagent pack, calibrator kit 19, and FS calibrator 1, processed by the VITROS 5,1 FS Chemistry System integrated with the enGen Laboratory Automation System. The system performs spectrophotometric analysis on human serum or plasma samples. The Laboratory Automation System manages pre-analytical and post-analytical sample handling and data. The device is used in clinical laboratory settings by trained personnel. Output consists of quantitative HDL cholesterol measurements, which healthcare providers use to assess lipid profiles and inform clinical decision-making regarding cardiovascular health and patient management.
Clinical Evidence
Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to assess impact of enGen system integration.
Technological Characteristics
System utilizes spectrophotometric liquid reagent methods for HDL cholesterol measurement. Integrates chemistry analyzer with laboratory automation for sample/data management. Operates via discrete photometric analysis. Reagents and calibrators are specific to the VITROS platform.
Indications for Use
Indicated for in vitro quantitative measurement of HDL cholesterol in human serum or plasma for clinical diagnostic purposes. Prescription use only.
Regulatory Classification
Identification
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)
To: THE FILE
RE: DOCUMENT NUMBER K063144
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.) k031924
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 ___Addition of the enGen system which is a combination of a lab automation control system and an instrument management software.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.
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.
