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

Intended 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Nano-Ditech Corporation c/o Dr. Young Hoon Kim President/CEO 7 Clarke Drive, Suite 3 Cranbury, New Jersey 08512

OCT 2 0 2010

k102131 Re:

> Trade Name: In Vitro Nano-Check™ AMI cTnI Cardiac Marker Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Codes: MMI Dated: September 16, 2010 Received: September 21, 2010

Dear Dr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of premier the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free mmber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## OCT 2 0 2010

510(k) Number (if known):___k102131

Device Name:

In Vitro Nano-Check ™ AMI cTnI Cardiac Marker Test

Indications For Use:

The In Vitro Nano-Check ™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl) in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).

The In Vitro Nano-Check ™ AMI cTnl Test is a qualitative assay, which cannot monitor the rise and fall of cTnl in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other test results and patient clinical findings.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_k10213

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