# K020842: Ertapenem 10UG BBL Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 15, 2002 after 61 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: 1 (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. The FDA summary names its predicate without a number.
- (no number) BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 ug: named in the summary without a submission number

## Recalls of this device
- Jan 8, 2024 · Class II · Z-1030-2024: There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adv

## Indications for use
Use of Ertapenem 10 ug, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ertapenem. Ertapenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic. Active In Vitro and in clinical infections against: Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes Aerobic gram-negative microorganisms Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae

Source page: https://510kreport.com/device/K020842
Methodology: https://510kreport.com/methodology