510(k) Report

510(k) · Cleared

Cleared

Yeast Traffic Light Pna Fish

K093024510(k) TraditionalCleared Jul 15, 2010289-day reviewClass I21 CFR 866.2660

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

Advandx, Inc. · NZS Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast

Cleared on Jul 15, 2010 after a 289-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jul 15, 2010
Review
289 days
Class
Class I
Product code
NZS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K093024Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All NZS devices

NZS Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NZS

3in 2010

2010: 3
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZS

183in 2010

2010: 183 days median
2007high 183 (2010)2026

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

Recalls per year · NZS

No recall names NZS since 2007.

Adverse event reports per year · NZS

No MAUDE report names NZS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
2010318300
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C.…

Read the full statement (136 words)

Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. glabrata and C. krusei.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth. Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.

Indications for use as stated in the FDA 510(k) statement.

More from Advandx, Inc.

21 FDA decisions under this applicant name. See the company

  • K140619Meca XpressfishAdvandx, Inc. · 2014
  • K123418Gram-Negative Quickfish BCAdvandx, Inc. · 20131 recall
  • K121991Enterococcus Quickfish BCAdvandx, Inc. · 2013
  • K113371Staphylococcus Quickfish BCAdvandx, Inc. · 20121 recall
  • K101558GNR Traffic Light Pna FishAdvandx, Inc. · 2010

Recent decisions in NZS

The NZS category page

  • K092784C. Albicans/C. Glabrata Pna FishAdvandx, Inc. · 2010
  • K092655C. Albicans Pna FishAdvandx, Inc. · 2010

https://510kreport.com/device/K093024 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093024: Yeast Traffic Light Pna Fish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093024

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026