# K861700: Dimension (TM) Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Jun 11, 1986 after 37 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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.
9 later devices descend from it; 6 cite it directly.
0 of 10 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
- K061719: Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator;  Models K1167, KC212 (2006), 1 descendant of its own
- 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
- K162399: Atellica CH Magnesium (Mg) (2017), 0 descendants of its own

## Recalls of this device
- Aug 17, 2022 · Class II · Z-1816-2022: Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous result
- Feb 22, 2013 · Class II · Z-1049-2013: Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is process

Source page: https://510kreport.com/device/K861700
Methodology: https://510kreport.com/methodology