# P970007: Imx Tacrolimus II Assay

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Aug 26, 1997 after 189 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- 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.
9 later devices descend from it; 5 cite 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. PMA decisions do not claim a predicate device.

## Most influential descendants
- K070820: Architect Tacrolimus: Model 1L77 (2007), 4 descendants of its own
- K060503: Dimension Tacr Calibrator, Model DC107 (2006), 1 descendant of its own
- K203833: Tacrolimus Assay Kit (2023), 0 descendants of its own
- K173857: Elecsys Tacrolimus (2018), 0 descendants of its own
- K150168: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (2015), 0 descendants of its own

## Recalls of this device
- Nov 13, 2003 · Not classified · Z-0230-04: Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
- Sep 19, 2003 · Not classified · Z-0063-04: Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.

Source page: https://510kreport.com/device/P970007
Methodology: https://510kreport.com/methodology