# K955851: Axsym Vancomycin II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 9, 1996 after 134 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AxSYM Vancomycin assay: named in the summary without a submission number

## Most influential descendants
- K072036: Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 (2008), 1 descendant of its own
- K123947: Architect Ivancomycin (2013), 0 descendants of its own
- K063045: Immulite 2000, Immulite 2500 Vancomycin (2006), 0 descendants of its own
- K032811: Cedia Vancomycin Assay (2003), 0 descendants of its own
- K013076: Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator (2001), 0 descendants of its own

## Indications for use
The intended use of both assays is for the quantitative determination of vancomycin in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

Source page: https://510kreport.com/device/K955851
Methodology: https://510kreport.com/methodology