# K870074: Gram Negative and Gram Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Microscan Div. Baxter Healthcare Corp.
- Decided: Apr 14, 1987 after 96 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 9 (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
- Aug 8, 2014 · Class II · Z-1531-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1532-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1528-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1530-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1529-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1533-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Aug 8, 2014 · Class II · Z-1534-2015: Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
- Apr 8, 2014 · Class II · Z-1524-2015: Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due t
- Jul 31, 2008 · Not classified · Z-0541-2009: Falsely lowered imipenem MICs may result, leading to major errors in results.

Source page: https://510kreport.com/device/K870074
Methodology: https://510kreport.com/methodology