510(k) Report

510(k) · Cleared

Cleared

Microscan Microstrep Plus Panel New Antimicrobial-Gatifloxacin

K020627510(k) TraditionalCleared May 6, 200269-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

Dade Microscan, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on May 6, 2002 as substantially equivalent to K963641 (Dade Microscan, Inc., 1996) after a 69-day review. Its family tree reaches back 1 generation to 1996.

Decided
May 6, 2002
Review
69 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963641 (1996). No later device cites it as a predicate yet.

K963641 · Streptococcus Mic Panel · Dade Microscan, Inc. · 199619961998200020022004
K963641 · Streptococcus Mic Panel · Dade Microscan, Inc. · 19960
  1. Root · 1 generation backK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
  2. This deviceK020627 Microscan Microstrep Plus Panel New Antimicrobial-GatifloxacinDade Microscan, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963641Streptococcus Mic PanelDade Microscan, Inc.1996—
0 (this device)K020627Microscan Microstrep Plus Panel New Antimicrobial-GatifloxacinDade Microscan, Inc.2002—
FIG. 1 — Lineage of K020627, 1996–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963641Streptococcus Mic Panel
Summary page 1
…n for Use For determining antimicrobic susceptibility with aerobic streptococci, including Streptococcus pneumoniae Predicate device: MicroScan® Streptococcus MIC Panel (K963641). 510(k) Summary: The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent…
Dade Microscan, Inc.1996—

Also cleared against K963641: 21 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?

  • Its one ancestor has no recall.
  • 21 other devices also cite its predicate K963641.

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.

FDA decisions per year · LTT

3in 2025

2009: 22010: 12011: 12013: 22015: 12017: 42019: 12020: 42025: 3
2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTT

219in 2025

2017: 132 days median2020: 90 days median2025: 219 days median
2007high 219 (2025) · low 90 (2020)2026

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

Recalls per year · LTT

7in 2015

2015: 7
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

2007: 72008: 42009: 12010: 12011: 12013: 52014: 92015: 102016: 12017: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—04
20092—01
20101—01
20111—01
20120—00
20132—05
20140—09
20151—710
20160—01
2017413203
20180—00
20191—00
202049000
20210—00
20220—00
20230—00
20240—00
2025321900
20260—0—

What is it indicated for?

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 Gatifloxacin at concentrations of 0.06 to 8 mcg/ml to the test panel

The organisms which may be used for Gatifloxacin susceptibility testing in this panel are;

Streptococcus pneumoniae

Streptococcus pyogenes

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963641

21 other devices cite the same predicate.

  • K021184Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinDade Microscan, Inc. · 2002
  • K021181Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinDade Microscan, Inc. · 2002
  • K021018Microscan Microstrep Plus Panel - ChloramphenicolDade Microscan, Inc. · 2002
  • K021078Microscan Microstrep Plus Panel New Antimicrobial-ErythromycinDade Microscan, Inc. · 2002
  • K021110Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc. · 2002
  • K021169Microstrep Plus Panel, AzithromycinDade Microscan, Inc. · 2002

More from Dade Microscan, Inc.

40 FDA decisions under this applicant name. See the company

  • K043589Microscan Dried Gram-Positive Mic/Combo Panels - ErtapenemDade Microscan, Inc. · 2005
  • K023202Microscan Synergies PlusDade Microscan, Inc. · 2002
  • K021184Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinDade Microscan, Inc. · 2002
  • K021181Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinDade Microscan, Inc. · 2002
  • K021018Microscan Microstrep Plus Panel - ChloramphenicolDade Microscan, Inc. · 2002

Recent decisions in LTT

The LTT category page

  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc. · 2025
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 20201 recall
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K020627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020627: Microscan Microstrep Plus Panel New Antimicrobial-Gatifloxacin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020627

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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