# LDP: Colorimetry, Acetaminophen

- Device class: 2; regulation: 21 CFR 862.3030; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 525 days (middle half 525–525)
- Recalls: 6 (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)
- 2001: 1
- 2002: 2
- 2005: 2
- 2006: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2019: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K043242: Triage Tox Drug Screen (2005), cited by 3
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 (2009), cited by 2
- K002974: Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model 7A409UL (2000), cited by 2
- K011465: Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 Pro (2001), cited by 1
- K840941: TDX Acetaminophen (1984), cited by 1
- K013757: Roche Acetaminophen (2002), cited by 1
- K042330: Acetaminophen-SL Assay (2005), cited by 1
- K991598: Cobas Integra Acetaminophen (1999), cited by 1
- K963244: Acetaminophen Flex Reagent Cartridge (1996), cited by 1
- K061655: Dimension Vista Flex Reagent Cartridges (2006), cited by 1

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