VANTERA CLINICAL ANALYZER

K133849 · Liposcience · NSU · Oct 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133849
• Device Name: VANTERA CLINICAL ANALYZER
• Applicant: Liposcience
• Product Code: NSU · Clinical Chemistry
• Decision Date: Oct 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Indications for Use

The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples. The NMR LipoProfile® test, when used with the Vantera® Clinical Analyzer, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

Device Story

Vantera Clinical Analyzer; fully automated in vitro diagnostic system; utilizes NMR spectroscopy for analyte measurement in human serum/plasma. Modification includes updates to NMR console (magnet, probe, RF transmitter/receiver), fluidics system, software version, sample handling, cryogen monitor, WASH barcode reader, and addition of rinse pump tachometer. Operated by trained laboratory professionals in clinical laboratory environments. Device transforms NMR signals into qualitative/semi-quantitative analyte data. Output used by clinicians for diagnostic decision-making. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and comparative performance verification between modified and predicate systems.

Technological Characteristics

NMR spectroscopy-based analyzer. Components: NMR console (magnet, probe, RF transmitter/receiver), fluidics system, sample handling system, cryogen monitor, barcode reader, rinse pump tachometer. Risk management per ISO 14971. Software-controlled automation.

Indications for Use

Indicated for use in clinical laboratories to measure lipoprotein particles (LDL-P, HDL-C, and triglycerides) in human serum and plasma to aid in the management of lipoprotein disorders associated with cardiovascular disease.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

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. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Vantera Clinical Analyzer (K113830)

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 K133849

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.) Vantera Clinical Analyzer (K113830).
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 modifications that included changes to the NMR console that controls the NMR (magnet, probe and RF transmitter and receiver), fluidics system, software version, sample handling system, cryogen monitor, WASH barcode reader, and addition of a rinse pump tachometer.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytical performance.
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. The sponsor states that the risk management is based on the ISO 14971 standard.
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.