# LCP: Assay, Glycosylated Hemoglobin

- Device class: 2; regulation: 21 CFR 864.7470; FDA's rule: 510(k) required
- FDA decisions: 249
- 510(k) review time 2021–2025: median 636 days (middle half 419–784)
- Recalls: 90 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2014: 8
- 2015: 3
- 2016: 2
- 2017: 5
- 2018: 2
- 2019: 4
- 2020: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K934070: Tina-Quant Hemoglobin A1C (1994), cited by 6
- K971919: Ezchek/Hba Blood Collection Kit (1997), cited by 6
- K984268: Variant II Hemoglobin A1C Program (1998), cited by 6
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (2015), cited by 5
- K071466: Dca Vantage, Model 5075 (2007), cited by 5
- K011434: G7 Automated HPLC Analyzer (2001), cited by 5
- K951361: Dca 2000 System for Hemoglobin A1C (1995), cited by 5
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU (2007), cited by 5
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec (2009), cited by 3
- K050574: Afinion Hbalc (2005), cited by 3

Source page: https://510kreport.com/product-code/LCP
Data by year (CSV): https://510kreport.com/product-code/LCP.csv