# MID: System, Test, Anticardiolipin Immunological

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 94
- 510(k) review time 2021–2025: median 809 days (middle half 809–809)
- Recalls: 13 (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: 5
- 2002: 10
- 2003: 5
- 2004: 1
- 2006: 1
- 2010: 2
- 2011: 1
- 2012: 2
- 2013: 3
- 2024: 1

## Most-cited predicates
- K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0 (1993), cited by 4
- K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 (2002), cited by 3
- K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls (2010), cited by 3
- K941840: Hemagen Acl Iga Calibrator (1994), cited by 2
- K953366: Quanta Lite Iga Aca (HRP) (1995), cited by 1
- K020758: Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696 (2002), cited by 1
- K022990: Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001 (2002), cited by 1
- K120817: Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga (2013), cited by 1
- K131821: Elia (TM) Cardiolipin Iga Immunoassay (2013), cited by 1
- K020752: Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596 (2002), cited by 1

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