# K913459: The E Test, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Sep 25, 1991 after 51 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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.
2 later devices descend from it; 1 cites 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963036: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (1996), 1 descendant of its own
- K262163: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (2026), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0819-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Nov 9, 2022 · Class II · Z-0823-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Apr 13, 2017 · Class II · Z-0264-2018: QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results
- Apr 13, 2017 · Class II · Z-0265-2018: QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results
- Dec 15, 2016 · Class II · Z-1522-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
- Dec 15, 2016 · Class II · Z-1530-2017: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Source page: https://510kreport.com/device/K913459
Methodology: https://510kreport.com/methodology