# K951361: Dca 2000 System for Hemoglobin A1C

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: May 5, 1995 after 39 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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; 5 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
- K050574: Afinion Hbalc (2005), 9 descendants of its own
- K110056: Afinion Analyzer (2011), 8 descendants of its own
- K071466: Dca Vantage, Model 5075 (2007), 8 descendants of its own
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (2015), 6 descendants of its own
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer (2017), 2 descendants of its own

## Recalls of this device
- Feb 7, 2024 · Class II · Z-1304-2024: The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test result

Source page: https://510kreport.com/device/K951361
Methodology: https://510kreport.com/methodology