# K970385: Sparflozacin, 5 MCG, Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Mar 10, 1997 after 35 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- 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 its predicate without a number.
- (no number) Ofloxacin, 5 mcg, Sensi-Disc®: named in the summary without a submission number

## Indications for use
Use of BBL® Sparfloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Sparfloxacin. Sparfloxacin has been shown to be active against most strains of microorganisms listed below, both /n vitro and in clinical infections, as described in the Rhone Poulenc Rorer Pharmaceuticals, Inc., package insert for this antimicrobic. Aerobic Gram-Positive Microorganisms Staphylococcus aureus Streptococcus pneumoniae (penicillin-susceptible strains) - Aerobic Gram-Negative Microorganisms Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Other Microorganisms Chlamydia pneumoniae Mycoplasma pneumoniae

Source page: https://510kreport.com/device/K970385
Methodology: https://510kreport.com/methodology