# K000535: Quanta Lite LKM-1 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 7, 2000 after 111 days
- Product code: NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K163538: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (2017), 0 descendants of its own
- K113439: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) (2013), 0 descendants of its own
- K112223: Euroimmun Anti-LKM-1 Elisa (LGG) (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K000535
Methodology: https://510kreport.com/methodology