# K072189: Pathfast Ntprobnp and D-Dimer Tests

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Kagaku Iatron
- Decided: Feb 5, 2008 after 183 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 30, 2018 · Class II · Z-3186-2018: A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12

Source page: https://510kreport.com/device/K072189
Methodology: https://510kreport.com/methodology