# K050975: Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB and Myoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Nano-Ditech Co.
- Decided: Mar 2, 2006 after 318 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030057 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030057: Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 Test, Spectral Diagnostics, Inc. (2003) Summary page 1.

## Indications for use
The Nano-Check TMAMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnI), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI). The Nano-CheckTM AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.

Source page: https://510kreport.com/device/K050975
Methodology: https://510kreport.com/methodology