# K912143: Cedia (R) Tobramycin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jul 26, 1991 after 72 days
- Product code: LFW (Fluorescence Polarization Immunoassay, Tobramycin)
- Device class: 2
- Regulation: 21 CFR 862.3900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K963191: Cedia Antibiotic TDM Multi-Cals (1996), 0 descendants of its own

## Recalls of this device
- Oct 16, 2013 · Class II · Z-0513-2014: Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
- Feb 10, 2006 · Not classified · Z-0574-06: May have tobramycin over-recovery at the trough level.

Source page: https://510kreport.com/device/K912143
Methodology: https://510kreport.com/methodology