# K896493: Accuprobe Mycobacterium Tuberculosis Complex Test

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Apr 11, 1990 after 149 days
- Product code: LQF (Dna-Reagents, Mycobacterium Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3370
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 30, 2008 · Not classified · Z-1438-2011: This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, pa

Source page: https://510kreport.com/device/K896493
Methodology: https://510kreport.com/methodology