# K860153: Oxoid Antimicrobial Susceptibility Discs

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid U.S.A., Inc.
- Decided: Mar 4, 1986 after 48 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: 6 (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
- Nov 6, 2015 · Class II · Z-0443-2016: Antibiotic concentration may be insufficient which may result in incorrect test results.
- Feb 18, 2014 · Class II · Z-1246-2014: Some of the discs may not be impregnated with the antibiotic.
- Apr 9, 2013 · Class II · Z-0794-2014: Cartridges may contain individual discs which were not impregnated with antibiotic.
- Mar 25, 2013 · Class III · Z-2081-2013: Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
- Nov 21, 2012 · Class III · Z-0528-2014: Boxes labeled as CIP5 may contain cartridges of AMP5.
- Aug 21, 2012 · Class II · Z-0808-2013: The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Source page: https://510kreport.com/device/K860153
Methodology: https://510kreport.com/methodology