510(k) Report

510(k) · Cleared

Cleared

Microscan Dried Gram-Positive Mic/Combo Panels - Ceftaroline

K123933510(k) TraditionalCleared Mar 14, 201384-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 Mar 14, 2013 as substantially equivalent to K003619 (Dade Microscan, Inc., 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.

Decided
Mar 14, 2013
Review
84 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003619 (2001). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2025: 1 descendant clearedK003619 · Dried Gram-Positive Mic/Combo Panels · Dade Microscan, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants K003619 · Dried Gram-Positive Mic/Combo Panels · Dade Microscan, Inc. · 20010
  1. Root · 1 generation backK003619 Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 2001
  2. This deviceK123933 Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc. · 2013
  3. Descendant · cites it directly · 2 of its ownK150039 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin…Siemens Healthcare Diagnostics, Inc. · 2015
  4. Descendant · 2 generations on · 0 of its ownK250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP)…Beckman Coulter, Inc. · 2025
  5. Descendant · 2 generations on · 0 of its ownK152346 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64…Beckman Coulter, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly2descendants
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025 · 2 generations on0descendants
  • K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003619Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc.2001—
0 (this device)K123933Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc.2013—
+1K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc.2015—
+2K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32…Beckman Coulter, Inc.2025—
+2K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
202510
FIG. 1 — Lineage of K123933, 2001–2025Source: 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
*K003619Dried Gram-Positive Mic/Combo Panels
Summary page 1
…t Code: LTT 5 10(k) Notification: New antimicrobial - Ceftaroline Predicate device: MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid (K003619) 510(k) Summary: MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative a…
Dade Microscan, Inc.2001—

Also cleared against K003619: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc.20152

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.
  • Of its descendants, K150039 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K003619.

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. 2013, this device’s year, is highlighted.

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 MicroScane Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16 -20 hours at 35 0 C +/- I C in a non-C02 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular…

Read the full statement (120 words)

The MicroScane Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16 -20 hours at 35 0 C +/- I C 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 Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.

The gram-positive organisms which may be used for Ceftaroline susceptibility testing in this panel are:

Staphylococcus aureus

* methicillin-susceptible and methicillin-resistant isolates - skin isolates only

* methicillin-susceptible isolates - community-acquired bacterial pneumonia isolates

Indications for use as stated in the FDA summary.

Also cleared against K003619

1 other device cites the same predicate.

  • K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc. · 2013

More from Siemens Healthcare Diagnostics, Inc.

281 FDA decisions under this applicant name. See the company

  • P930027/S041IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
  • P010007/S028IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026
  • P240021/S001Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026
  • P930027/S040IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
  • P010007/S027IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026

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/K123933 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123933: Microscan Dried Gram-Positive Mic/Combo Panels - Ceftaroline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123933

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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