# K202612: Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jul 23, 2021 after 317 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sensititre Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 µg/ml and clindamycin at 0.5 µg/ml) broth test for Streptococcus pneumoniae and Streptococcus spp.-β-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing. The Dtest for broth microdilution is for the detection of inducible clindamycin resistance in Streptococcus spp. resistant to erythromycin (MICs ≥ 1μg/mL) and either susceptible (MIC ≤ 0.25 μg/mL) or intermediate (MIC equal to 0.5 μg/mL) to clindamycin. Dtest is intended for use with the following Streptococcus species: Streptococcus pneumoniae Streptococcus agalactiae Streptococcus pyogenes

Source page: https://510kreport.com/device/K202612
Methodology: https://510kreport.com/methodology