# K972232: Abbott Axsym Folate

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 24, 1997 after 8 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) IMx Folate: named in the summary without a submission number

## Most influential descendants
- K092740: Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74 (2010), 1 descendant of its own
- K192586: LIAISON® Folate (2020), 0 descendants of its own

## Recalls of this device
- Jan 19, 2009 · Not classified · Z-1049-2009: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
- Apr 23, 2007 · Not classified · Z-1029-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru
- Dec 16, 2003 · Not classified · Z-0367-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0366-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0365-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Dec 16, 2003 · Not classified · Z-0368-04: The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

## Indications for use
Abbott AxSYM® Folate is an lon Capture Assay intended to measure the vitamin folic acid in serum, plasma, and red blood cells. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Source page: https://510kreport.com/device/K972232
Methodology: https://510kreport.com/methodology