# K102131: Nano-Check Ami Ctni Cardiac Marker Test

- Pathway: 510(k) (Special)
- Applicant: Nano-Ditech Corporation
- Decided: Oct 20, 2010 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The In Vitro Nano-Check™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnI) 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 cTnI Test is a qualitative assay, which cannot monitor the rise and fall of cTnI 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.

Source page: https://510kreport.com/device/K102131
Methodology: https://510kreport.com/methodology