# K926562: Quanta Lite (TM) JO-1 Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Mar 4, 1993 after 63 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg) (2013), 1 descendant of its own
- K040200: Mesacup-2 Test Cenp-B (2004), 1 descendant of its own
- K140224: Euroimmun Euroline Ena Profile 9AG (Igg) (2014), 0 descendants of its own
- K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805 (2006), 0 descendants of its own
- K033528: Mesacup-2 Test JO-1, Model 10756 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K926562
Methodology: https://510kreport.com/methodology