# K933588: Aphlelisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Apl Diagnostics, Inc.
- Decided: Oct 13, 1994 after 444 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 18, 2006 · Not classified · Z-0034-2008: Product mislabeled; outer container labeled with incorrect lot number.
- Oct 6, 2005 · Not classified · Z-1176-2007: Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
- Oct 6, 2005 · Not classified · Z-1177-2007: Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
- Oct 6, 2005 · Not classified · Z-1175-2007: Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
- Aug 10, 2004 · Not classified · Z-1104-2007: Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
- Aug 10, 2004 · Not classified · Z-1103-2007: Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.

Source page: https://510kreport.com/device/K933588
Methodology: https://510kreport.com/methodology