# K990551: Igg Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 25, 1999 after 31 days
- Product code: CFQ (Radioimmunoassay, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922273 (1992). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922273: Array (R) 360, Beckman Instruments, Inc. (1992) Summary page 1.

## Most influential descendants
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K143720: Dimension Vista MMB Assay (2015), 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

## Indications for use
The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.

Source page: https://510kreport.com/device/K990551
Methodology: https://510kreport.com/methodology