# K924898: Quanta Lite (TM) SCL-70 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Dec 15, 1992 after 78 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
- K152635: QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls (2016), 1 descendant of its own
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg) (2013), 1 descendant of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K140224: Euroimmun Euroline Ena Profile 9AG (Igg) (2014), 0 descendants of its own
- K140493: Elia SCL-70S Immunoassay (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K924898
Methodology: https://510kreport.com/methodology