510(k) Report

FDA product code · Microbiology

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

OEHClass II21 CFR 866.3280510(k) required2 decisions since 20070 recalls

2 FDA decisions since 2007. No recall names this code. The most-cited predicate is K072547, named by 1 later device.

To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.

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

FIG. A — Illustration, microbiology panel

Twenty years of OEH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OEH

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OEH

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

Recalls per year · OEH

No recall names OEH since 2007.

Adverse event reports per year · OEH

No MAUDE report names OEH since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
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—
FIG. 1 — OEH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OEH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OEH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 20071cites it

Which OEH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K131936Jbaids Tularemia Detection KitBiofire Diagnostics, Inc. · 20132generations
  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 20071generation

What has FDA decided in OEH lately?

  • K131936Jbaids Tularemia Detection KitBiofire Diagnostics, Inc. · 2013
  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 2007

All 2 OEH decisions →

Related product codes

Other codes under 21 CFR 866.3280.

GSK Antiserum, Francisella TularensisGSJ Antiserum, Fluorescent, Francisella TularensisGSL Antigens, Slide And Tube, Francisella Tularensis