# K860021: Dimension (TM) Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Feb 11, 1986 after 39 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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.
21 later devices descend from it; 9 cite it directly.
0 of 22 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
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K061390: Dimension Vista System ENZYME2 Calibrator, Model KC320 (2006), 3 descendants of its own
- K061818: Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330) (2006), 2 descendants of its own
- K031135: Glucose Flex Reagent Cartridge (Gluc) (2003), 2 descendants of its own
- K103612: Dimension Visa Enz 2 Cal (2011), 1 descendant of its own

## Recalls of this device
- Jul 19, 2011 · Not classified · Z-3039-2011: Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dL

Source page: https://510kreport.com/device/K860021
Methodology: https://510kreport.com/methodology