# K862359: Meth./Cali./Intru. Check for the Dimension System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Aug 19, 1986 after 57 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K060628: Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator (2006), 1 descendant of its own
- K222104: Atellica® CH Diazo Total Bilirubin (D_TBil) (2023), 0 descendants of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own
- K061839: Dimension Vista Dbil Flex Reagent Cartridge, Model K2125 (2006), 0 descendants of its own

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1654-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep
- Mar 17, 2016 · Class II · Z-1662-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

Source page: https://510kreport.com/device/K862359
Methodology: https://510kreport.com/methodology