# P870049: Microscan Rapid Panels

- Pathway: PMA
- Applicant: Dade Intl., Inc.
- Decided: Feb 24, 1988 after 188 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 3 (2 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 17, 2014 · Class I · Z-0171-2015: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
- Oct 17, 2014 · Class I · Z-0170-2015: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
- Feb 7, 2005 · Not classified · Z-0668-05: There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

Source page: https://510kreport.com/device/P870049
Methodology: https://510kreport.com/methodology