# K020626: Microscan Microstrep Plus Panel New Antimicrobial-Penicillin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Apr 26, 2002 after 59 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963641 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963641: Streptococcus Mic Panel, Dade Microscan, Inc. (1996) Summary page 1.

## Recalls of this device
- Sep 10, 2015 · Class II · Z-0108-2016: Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results
- Sep 10, 2015 · Class II · Z-0109-2016: Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results

## 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, including 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 Package Insert. This particular submission is for the addition of the antimicrobial Penicillin at concentrations of 0.015 to 16 mcg/ml to the test panel The organisms which may be used for Penicillin susceptibility testing in this panel are: Streptococcus pneumoniae Streptococci (Groups A, C, G, H, L and M)

Source page: https://510kreport.com/device/K020626
Methodology: https://510kreport.com/methodology