510(k) Report

510(k) · Cleared

Cleared

Dried Gram-Positive Mic/Combo Panels

K003619510(k) TraditionalCleared Jan 9, 200148-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 Jan 9, 2001 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jan 9, 2001
Review
48 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2015: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003619 Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK123933 Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc. · 2013
  3. Descendant · 2 generations on · 2 of its ownK150039 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin…Siemens Healthcare Diagnostics, Inc. · 2015
  4. Descendant · 3 generations on · 0 of its ownK250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP)…Beckman Coulter, Inc. · 2025
  5. Descendant · 3 generations on · 0 of its ownK152346 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64…Beckman Coulter, Inc. · 2015
  6. Descendant · cites it directly · 0 of its ownK131275 Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc. · 2013

Most influential descendants

Showing 5 of 5 · See all
  • K123933Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc. · 2013 · cites it directly3descendants
  • K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on2descendants
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025 · 3 generations on0descendants
  • K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc. · 2015 · 3 generations on0descendants
  • K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003619Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc.2001—
+1K123933Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc.2013—
+2K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Siemens Healthcare Diagnostics, Inc.2015—
+3K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32…Beckman Coulter, Inc.2025—
+3K152346MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc.2015—
+1K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201520
202510
FIG. 1 — Lineage of K003619, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123933Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc.20133
K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc.20130

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?

  • Of its descendants, K123933 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 3 descendants of its own.

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—

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/K003619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003619: Dried Gram-Positive Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003619

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026