510(k) Report

510(k) · Cleared

Cleared

GBS Pna Fish

K082612510(k) TraditionalCleared May 5, 2009238-day reviewClass I21 CFR 866.3740

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

Advandx, Inc. · OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Cleared on May 5, 2009 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 5, 2009
Review
238 days
Class
Class I
Product code
OAH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K082612Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 OAH? 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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 OAH devices

OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OAH

1in 2013

2009: 22013: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAH

Too few OAH 510(k)s in any year since 2007 to give a median.

Recalls per year · OAH

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · OAH

No MAUDE report names OAH since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—00
20100—10
20110—00
20120—00
20131—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—

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 OAH

The OAH category page

  • K121991Enterococcus Quickfish BCAdvandx, Inc. · 2013
  • K083074Avandx E. Faecalis/OE Pna Fish Culture Identification KitAdvandx, Inc. · 20091 recall
  • K063127Enterococcus Faecalis Pna FishAdvandx, Inc. · 2006

https://510kreport.com/device/K082612 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082612: GBS Pna Fish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082612

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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