# K010748: Synchron Systems Hemoglobin A1C Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 10, 2001 after 119 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K121492: Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) Reagent (2012), 1 descendant of its own
- K140829: Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) Reagent (2014), 0 descendants of its own
- K120199: Glycosylated Hemoglobin Assay; Clinical Chemistry (2012), 0 descendants of its own
- K042459: Synchron LX Systems Hemoglobin A1C2 (HBA1C2) Reagent (2004), 0 descendants of its own

## Recalls of this device
- Aug 18, 2003 · Not classified · Z-1156-04: Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
- Aug 15, 2003 · Not classified · Z-1155-04: LDL Cholesterol component in controls are unstable.

Source page: https://510kreport.com/device/K010748
Methodology: https://510kreport.com/methodology