# LTT: Panels, Test, Susceptibility, Antimicrobial

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 52
- 510(k) review time 2021–2025: median 219 days (middle half 203–236)
- Recalls: 7 (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)
- 2006: 2
- 2009: 2
- 2010: 1
- 2011: 1
- 2013: 2
- 2015: 1
- 2017: 4
- 2019: 1
- 2020: 4
- 2025: 3

## Most-cited predicates
- K162740: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (2017), cited by 3
- K001721: Pasco Mic and Mic/ID Panels (2000), cited by 2
- K010508: Pasco Mic and Mic/ID Panels (2001), cited by 2
- K030620: Pasco Mic and Mic/ID Panels (2003), cited by 2
- K003619: Dried Gram-Positive Mic/Combo Panels (2001), cited by 2
- K202343: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (2020), cited by 2
- K011116: Pasco Mic and Mic/ID Panels Inclusion of Esbl Confirmatory Test (2001), cited by 2
- K150039: MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (2015), cited by 2
- K083262: Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML) (2009), cited by 1
- K020939: Microscan Microstrep Plus Panel-Tetracycline (2002), cited by 1

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