# K133847: Sensititre Haemophilus / Streptococcus Pneumoniae (HP) Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Aug 1, 2014 after 226 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 plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species. Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 μg/ml and clindamycin at 0.5μg/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 test is for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae resistant to erythromycin (MICs ≥ 1 μg/mL) and susceptible or intermediate to clindamycin (MICs ≤ 0.25 μg/mL or 0.5 μg/mL), and to determine absence of inducible clindamycin resistance in Streptococcus pneumoniae. The performance of this test for the detection of inducible clindamycin resistance in isolates of S. pneumoniae has not been established. With S. pyogenes and S. agalactiae, a Dtest (1/0.5 μg/ml) positive (growth) test, determined by manual read, should be reported as inducible clindamycin resistance.

Source page: https://510kreport.com/device/K133847
Methodology: https://510kreport.com/methodology