# K833379: Lidocaine Analytical Test Pack Aca

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Dec 27, 1983 after 89 days
- Product code: KLR (Enzyme Immunoassay, Lidocaine)
- Device class: 2
- Regulation: 21 CFR 862.3555
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices 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.

## Most influential descendants
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D (2004), 8 descendants of its own
- K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (2016), 2 descendants of its own
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K222439: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (2023), 0 descendants of its own
- K161954: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K833379
Methodology: https://510kreport.com/methodology