ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

K092649 · Roche Diagnostics Corp. · NBC · Feb 4, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092649
• Device Name: ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
• Applicant: Roche Diagnostics Corp.
• Product Code: NBC · Clinical Chemistry
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

Device Story

In vitro diagnostic immunoassay; measures N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum/plasma. Uses electrochemiluminescence immunoassay (ECLIA) technology; sandwich assay format with two monoclonal antibodies directed at NT-proBNP epitopes; capture antibody biotinylated for streptavidin-coated microparticles; signal antibody tagged with ruthenium. Operated on cobas e 601 analyzer by laboratory professionals. Provides quantitative results in 9 minutes (STAT application). Results used by clinicians alongside medical history and clinical examination to aid diagnosis of congestive heart failure, risk stratification for acute coronary syndrome, and assessment of cardiovascular event risk. Benefits include rapid turnaround time for critical cardiac assessment.

Clinical Evidence

Bench testing only. Performance characteristics evaluated include method comparison, recovery, limit of detection, limit of quantitation, precision, hook effect, and stability.

Technological Characteristics

In vitro diagnostic assay; modified from two-step to one-step incubation. Software updated to accommodate assay duration change. Reagent concentrations unchanged.

Indications for Use

Indicated for in vitro quantitative determination of NT-proBNP in human serum/plasma to aid in diagnosis of suspected congestive heart failure, risk stratification of patients with acute coronary syndrome and congestive heart failure, and assessment of increased risk of cardiovascular events/mortality in patients at risk for heart failure with stable coronary artery disease.

Regulatory Classification

Identification

The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

Predicate Devices

• k072437

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 k092649

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.) k072437
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 decreased duration of assay due to change from two-step incubation to one-step incubation (reagents and their concentrations were not changed) and an accompanying software change.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics, and performance characteristics including method comparison, recovery, limit of detection and quantitation, precision, hook effect and stability.

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.