# K221493: MicroScan Prompt Inoculation System-D

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 5, 2023 after 317 days
- Product code: LIE (Reagent/Device, Inoculum Calibration)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820299 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820299: Prompt Inoculation System, 3M Company (1982) Summary page 4.

## Indications for use
The MicroScan Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests. The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.

Source page: https://510kreport.com/device/K221493
Methodology: https://510kreport.com/methodology