510(k) · Cleared

Cleared

Microscan Microstep

K111394510(k) TraditionalCleared Jun 22, 201135-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on Jun 22, 2011 as substantially equivalent to K020556 (Dade Microscan, Inc., 2002) after a 35-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 22, 2011
Review: 35 days
Class: Class II
Product code: LTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K963641 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
1 generation backK020556 Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc. · 2002
This deviceK111394 Microscan MicrostepSiemens Healthcare Diagnostics, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963641	Streptococcus Mic Panel	Dade Microscan, Inc.	1996	—
−1	K020556	Microscan Microstrep Plus Panel with Levofloxacin	Dade Microscan, Inc.	2002	—
0 (this device)	K111394	Microscan Microstep	Siemens Healthcare Diagnostics, Inc.	2011	—

FIG. 1 — Lineage of K111394, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LTT device

#1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K020556	Microscan Microstrep Plus Panel with Levofloxacin Summary page 1 …icrobial agent susceptibility 510(k) Notification: New antimicrobial - Daptomycin Predicate device: MicroScan MICroSTREP plus Panels - Levofloxacin (K020556) 510(k) Summary: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitativ…	Dade Microscan, Inc.	2002	—

Also cleared against K020556: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K020556.

How does its category compare?

All LTT devices

LTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LTT

3in 2025

2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTT

219in 2025

2007high 219 (2025) · low 90 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LTT

7in 2015

2007high 7 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LTT

3in 2017

2007high 10 (2015) · low 0 (2012)2025

MAUDE reports naming product code LTT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	7
2008	0	—	0	4
2009	2	—	0	1
2010	1	—	0	1
2011	1	—	0	1
2012	0	—	0	0
2013	2	—	0	5
2014	0	—	0	9
2015	1	—	7	10
2016	0	—	0	1
2017	4	132	0	3
2018	0	—	0	0
2019	1	—	0	0
2020	4	90	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	3	219	0	0
2026	0	—	0	—

What is it indicated for?

The MicroScan® MICroSTREP p/us® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci. After inoculation, panels are incubated for 20 -24 hours at 3500 +/- 100 in a non-C02 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Daptomycin at concentrations of 0.25 to 8 pg/mI to the test panel.

The organisms which may be used for Daptomycin susceptibility testing in this panel are:

Streptococcus pyogenes

Streptoccocus age/acie

Streptococcus dysglectiae su bsp. equisimilis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111394: Microscan Microstep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111394

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026