# K020037: Dried Gram Negative Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Mar 22, 2002 after 77 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MicroScan Dried Gram-Negative MIC/Combo Panels: named in the summary without a submission number

## Most influential descendants
- K061687: Microscan Dried Gram Negative Mic/Combo Panels (2006), 0 descendants of its own
- K061536: Microscan Dried Gram Negative Mic/Combo Panels (2006), 0 descendants of its own

## Indications for use
The MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CQO, incubator, and read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 pg/ml), Cefotaxime (0.5-128 pg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ng/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 pg/ml) to the test panel. The Gram-Negative organisms which may be used for detection of ESBL production in this panel are: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Source page: https://510kreport.com/device/K020037
Methodology: https://510kreport.com/methodology