# JBQ: Antithrombin Iii Quantitation

- Device class: 2; regulation: 21 CFR 864.7060; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 184 days (middle half 184–184)
- Recalls: 0 (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)
- 1998: 1
- 2000: 2
- 2002: 2
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2009: 1
- 2025: 1

## Most-cited predicates
- K980499: IL Test Antithrombin (1998), cited by 4
- K915083: Coamate (R) Antithrombin Chromogenic Assay (1992), cited by 2
- K994238: IL Test Liquid Antithrombin (2000), cited by 2
- K901977: Beckman Antithrombin Iii Reagent Kit (1990), cited by 1
- K883662: Berichrom (R) Antithrombin Iii (1988), cited by 1
- K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 (2003), cited by 1
- K022195: Coamatic at-400 (2002), cited by 1
- K062431: Hemosil Liquid Antithrombin (2006), cited by 1
- K033775: Hemosil Liquid Antithrombin XL (2004), cited by 1

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