# K010313: Dimension Ctni Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 20, 2001 after 77 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053577: Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent (2006), 2 descendants of its own
- K063756: Dimension Vista Ctni Flex Reagent Cartridge (2007), 1 descendant of its own
- K081683: Loci Cardiac Troponin I Calibrator, Model RC621 (2008), 0 descendants of its own
- K081643: Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692 (2008), 0 descendants of its own

## Recalls of this device
- Apr 8, 2008 · Not classified · Z-1731-2009: possibility of falsely elevated results
- Mar 2, 2007 · Not classified · Z-0858-2010: Tests exhibit falsely elevated results.

Source page: https://510kreport.com/device/K010313
Methodology: https://510kreport.com/methodology