ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)

K051752 · Roche Diagnostics · MMI · Jul 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051752
• Device Name: ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
• Applicant: Roche Diagnostics
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.

Device Story

The Elecsys Troponin T STAT assay is a two-step sandwich immunoassay utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. It measures human Troponin T in serum or plasma samples. The device is intended for use by clinical laboratory professionals on Roche Elecsys family immunoassay analyzers. The assay transforms the presence of Troponin T into a light signal proportional to the analyte concentration. Healthcare providers use the quantitative output to diagnose acute myocardial infarction, stratify ACS patient risk, and manage patients with chronic renal failure. The test aids in clinical decision-making regarding the necessity for intensive cardiac interventions. Benefits include rapid, sensitive detection of cardiac necrosis to facilitate timely clinical management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to assess impact of reagent and specimen type modifications; results met predetermined acceptance criteria.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles. Sample types: serum, K2/K3-EDTA, Li-heparin, Na-citrate plasma. Measuring range: 0.010-25.00 ng/mL. Analyzers: Roche Elecsys family. Reagent stability: 12 weeks opened at 2-8 °C. Contains additives to minimize interference from monoclonal mouse antibodies and anti-streptavidin antibodies.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for clinical laboratory testing; intended use remains unchanged from the previously cleared device.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Previously cleared device (K040733)

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 k051752

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.) k040733
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 addition of inhibitors to the R1 reagent. Also, the change was for the addition of anticoagulant Li-heparin and K2-EDTA plasma as acceptable specimen types.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use and physical characteristics. Labeling changes were made in association with the above listed modifications to traceability statement and to precision and method comparison data. There also were editorial changes to the package insert which included an addition of limited warranty statement, modification to wording of sample collection instructions, modification of calibration stability statement to harmonize with on-board reagent stability statement, addition of statement regarding foam formation and change to material number (catalog number) of assay.

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.