# K062841: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic and Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Dec 20, 2006 after 89 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. The FDA summary names no predicate by number.

## Indications for use
The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H. influenzae. This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32ttg/mL) for use with the Sensititre® Haemophilus infiuenzae/Streptococcuspneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for: Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiaesubsp. equisimilis

Source page: https://510kreport.com/device/K062841
Methodology: https://510kreport.com/methodology