# K202423: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: May 18, 2021 after 266 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
Longest line of descent: 2 generations back to K963641 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020939: Microscan Microstrep Plus Panel-Tetracycline, Dade Microscan, Inc. (2002) Summary page 3.
- K062923: Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 MCG/ML), Dade Behring, Inc. (2006) Summary page 3.

## Indications for use
The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococci and Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument. This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 — 16 pg/mL on the MicroScan MICroSTREP plus Panel (modification to K020939 and K062923). Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site. Streptococcus spp. Streptococcus pneumoniae

Source page: https://510kreport.com/device/K202423
Methodology: https://510kreport.com/methodology