IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

K034055 · Diagnostic Products Corp. · JHX · Jan 21, 2004 · Clinical Chemistry

Device Facts

• Record ID: K034055
• Device Name: IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
• Applicant: Diagnostic Products Corp.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

Device Story

IMMULITE 2500 series consists of solid-phase, two-site chemiluminescent enzyme immunoassays; designed for use with the IMMULITE 2500 Automated Analyzer. Input: patient serum, heparinized plasma, or EDTA plasma samples. Operation: automated analyzer performs chemiluminescent immunoassay to quantify specific cardiac markers (CK-MB, myoglobin, troponin I). Output: quantitative concentration values displayed to clinicians. Context: clinical laboratory environment; operated by laboratory technicians. Clinical utility: provides rapid diagnostic data to assist physicians in identifying or managing acute myocardial infarction and assessing prognosis. Benefits: enables timely clinical decision-making for cardiac patients.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on analytical performance and technological similarity to predicate devices.

Technological Characteristics

Solid-phase, two-site chemiluminescent enzyme immunoassay; automated analyzer platform; quantitative measurement of cardiac markers; serum/plasma sample types.

Indications for Use

Indicated for use with the IMMULITE 2500 Automated Immunoassay Analyzer for the performance of CK-MB, Myoglobin, and STAT Troponin I assays.

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

• IMMULITE/IMMULITE 1000 Turbo CK-MB (K022118)
• IMMULITE/IMMULITE 1000 Turbo Myoglobin (K991796)
• IMMULITE/IMMULITE 1000 Turbo Troponin I (K991795)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: k 034055

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.
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 the IMMULITE® 2500 CK-MB, IMMULITE® 2500 Myoglobin, IMMULITE® 2500 STAT Troponin I assays to the previously cleared (K033234) IMMULITE 2500 Automated Immunoassay Analyzer. In addition, the incubation times of these assays are being changed to provide a more rapid time to first result.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.
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. FMECA
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.