510(k) Report

510(k) · Cleared

Recalled · Class III · 2013

Gram-Negative Quickfish BC

K123418510(k) TraditionalCleared Jul 21, 2013257-day reviewClass I21 CFR 866.2660Recalls 1

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

Advandx, Inc. · JSS Kit, Identification, Enterobacteriaceae

Cleared on Jul 21, 2013 after a 257-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.

Decided
Jul 21, 2013
Review
257 days
Class
Class I
Product code
JSS
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2010201520202025
  1. This deviceK123418 Gram-Negative Quickfish BCAdvandx, Inc. · 2013
  2. Descendant · cites it directly · 0 of its ownK150031 hemoFISH MasterpanelMiacom Diagnostics GmbH · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K150031hemoFISH MasterpanelMiacom Diagnostics GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K123418Gram-Negative Quickfish BCAdvandx, Inc.2013—
+1K150031hemoFISH MasterpanelMiacom Diagnostics GmbH2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K123418, 2013–2015Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K150031hemoFISH MasterpanelMiacom Diagnostics GmbH20150

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 11, 2013Class IIIZ-0619-2014Process designKits incompatible with certain fluorescence microscope light sources

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K150031 (Miacom Diagnostics GmbH, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JSS devices

JSS Kit, Identification, Enterobacteriaceae: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JSS

1in 2015

2008: 12009: 42010: 12013: 12015: 1
2007high 4 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JSS

228in 2009

2009: 228 days median
2007high 228 (2009)2026

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

Recalls per year · JSS

1in 2022

2010: 22012: 32013: 12021: 12022: 1
2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JSS

1in 2023

2013: 12015: 12017: 32018: 32019: 32020: 82021: 92022: 22023: 1
2007high 9 (2021) · low 0 (2007)2025

MAUDE reports naming product code JSS, 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—00
20081—00
2009422800
20101—20
20110—00
20120—30
20131—11
20140—00
20151—01
20160—00
20170—03
20180—03
20190—03
20200—08
20210—19
20220—12
20230—01
20240—00
20250—00
20260—0—

More from Advandx, Inc.

21 FDA decisions under this applicant name. See the company

  • K140619Meca XpressfishAdvandx, Inc. · 2014
  • K121991Enterococcus Quickfish BCAdvandx, Inc. · 2013
  • K113371Staphylococcus Quickfish BCAdvandx, Inc. · 20121 recall
  • K101558GNR Traffic Light Pna FishAdvandx, Inc. · 2010
  • K093024Yeast Traffic Light Pna FishAdvandx, Inc. · 2010

Recent decisions in JSS

The JSS category page

  • K150031hemoFISH MasterpanelMiacom Diagnostics GmbH · 2015
  • K101558GNR Traffic Light Pna FishAdvandx, Inc. · 2010
  • K092236E.Coli/P. Aeruginosa Pna FishAdvandx, Inc. · 20091 recall
  • K092393EK/P. Aeruginosa Pna FishAdvandx, Inc. · 20091 recall
  • K082068E. Coli Pna FishAdvandx, Inc. · 2009

https://510kreport.com/device/K123418 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123418: Gram-Negative Quickfish BC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123418

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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