# LLL: Extractable Antinuclear Antibody, Antigen And Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 182
- 510(k) review time 2021–2025: median 231 days (middle half 225–471)
- Recalls: 4 (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)
- 2010: 1
- 2011: 1
- 2013: 2
- 2015: 3
- 2016: 2
- 2018: 1
- 2019: 1
- 2023: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K935129: Relisa Ena Antibody Screening Test System (1994), cited by 5
- K924898: Quanta Lite (TM) SCL-70 Elisa (1992), cited by 3
- K926562: Quanta Lite (TM) JO-1 Elisa Kit (1993), cited by 3
- K922833: Quanta Lite RNP Elisa (1992), cited by 3
- K922831: Quanta Lite SM Elisa (1992), cited by 3
- K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls (2015), cited by 3
- K922830: Quanta Lite SS-a Elisa (1992), cited by 3
- K880736: Nova Lite (TM) Ana (1988), cited by 2
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (2016), cited by 2
- K053653: Fidis Connective 10, Model MX006 (2006), cited by 2

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