# K862140: Microdilution Panels

- Pathway: 510(k) (Traditional)
- Applicant: American Micro Scan
- Decided: Jul 16, 1986 after 42 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 14, 2014 · Class II · Z-1522-2015: Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
- Jun 16, 2011 · Not classified · Z-1498-2012: Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
- Jun 16, 2011 · Not classified · Z-1499-2012: Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels
- Jun 16, 2011 · Not classified · Z-1497-2012: Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.

Source page: https://510kreport.com/device/K862140
Methodology: https://510kreport.com/methodology