# K060176: EL-Acl Screen; EL-Acl Igm, Igg, Iga

- Pathway: 510(k) (Special)
- Applicant: Theratest Laboratories, Inc.
- Decided: Feb 7, 2006 after 15 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 11, 2006 · Not classified · Z-0835-06: The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

## Indications for use
The TheraTest EL-aCL Tscreen and TheraTest EL-aCLc IgM, IgG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

Source page: https://510kreport.com/device/K060176
Methodology: https://510kreport.com/methodology