# K111023: Abbott Architect LH Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 10, 2011 after 58 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890135 (1989). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032458: Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott, Abbott Laboratories (2003) Summary page 1.

## Most influential descendants
- K163521: Lumipulse G LH Calibrators (2017), 0 descendants of its own

## Indications for use
The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

Source page: https://510kreport.com/device/K111023
Methodology: https://510kreport.com/methodology