NANO-CHECK AMI CTNI CARDIAC MARKER TEST

K102131 · Nano-Ditech Corporation · MMI · Oct 20, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102131
• Device Name: NANO-CHECK AMI CTNI CARDIAC MARKER TEST
• Applicant: Nano-Ditech Corporation
• Product Code: MMI · Clinical Chemistry
• Decision Date: Oct 20, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The Nano-check AMI 3 IN 1 Cardiac Marker Test is an immunochromatographic test for the qualitative detection of cardiac troponin I (cTnI), CK-MB and myoglobin in human whole blood or plasma. The test is intended for use as an aid in the diagnosis of myocardial infarction.

Device Story

In Vitro Nano-Check AMI cTnI Test is a rapid, qualitative immunoassay for detecting Cardiac Troponin I in human serum or plasma. Used as an aid in diagnosing Acute Myocardial Infarction (AMI). Operated by healthcare professionals in clinical settings. Device provides qualitative results at a 0.5 ng/mL cutoff. Results must be interpreted by a physician alongside clinical findings and other diagnostic tests. Single testing is insufficient for monitoring AMI progression. Device assists in rapid clinical decision-making for patients presenting with suspected cardiac events.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements to confirm performance following reagent removal. No clinical trial data required for this modification.

Technological Characteristics

Rapid immunoassay for qualitative detection of cTnI. Cutoff concentration: 0.5 ng/mL. Specimen types: human serum and plasma.

Indications for Use

Indicated for use as an aid in the diagnosis of myocardial infarction in patients presenting with symptoms suggestive of cardiac events. Uses human whole blood or plasma samples.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K102131

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, Nano-check AMI 3 IN 1 Cardiac Marker Test, k050975. (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 (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 removal of CKMB and myoglobin test line reagents.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance verification/validation information.

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.