510(k) · Cleared
ClearedModification to Jbaids Anthrax Detection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idaho Technology, Inc. · NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Cleared on May 21, 2007 as substantially equivalent to K051713 (Idaho Technology, Inc., 2005) after a 21-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- May 21, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- NHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922906 (1993). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 4 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 3 generations backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- 2 generations backK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- 1 generation backK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
- This deviceK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK140426 Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014
- Descendant · 2 generations on · 0 of its ownK192871 B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2019
- Descendant · cites it directly · 0 of its ownK131930 Jbaids Anthrax Detection KitBiofire Diagnostics, Inc. · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K140426Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014 · cites it directly1descendant
- K192871B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2019 · 2 generations on0descendants
- K131930Jbaids Anthrax Detection KitBiofire Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −4 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −3 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| −2 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| −1 | K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | 2005 | — |
| 0 (this device) | K071188 | Modification to Jbaids Anthrax Detection System | Idaho Technology, Inc. | 2007 | — |
| +1 | K140426 | Anthracis Real-Time PCR Assay | Centers For Disease Control and Prevention (CDC) | 2014 | — |
| +2 | K192871 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | 2019 | — |
| +1 | K131930 | Jbaids Anthrax Detection Kit | Biofire Diagnostics, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHT? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051713 | Jbaids Anthrac Detection SystemSummary page 3…ified JBAIDS Anthrax ELEMENT Unmodified MBAIDS Anthrax Detection System Detection System (K051713) Identification of anthrax infection through the detection of 2 DNA… | 2005 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K140426 (Centers For Disease Control and Prevention (CDC), 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051713.
How does its category compare?
All NHT devicesNHT Assay, Nucleic Acid Amplification, Bacillus Anthracis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · NHT
Too few NHT 510(k)s in any year since 2007 to give a median.
Recalls per year · NHT
No recall names NHT since 2007.
Adverse event reports per year · NHT
1in 2021
MAUDE reports naming product code NHT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The JBAIDS Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXOi plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and cultured organisms grown on blood…
Read the full statement (299 words)
The JBAIDS Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXOi plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and cultured organisms grown on blood agar plates. The MBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.
The JBMAIDS Anthrax Target 1 and Target 2 Assays are run on the MBAIDS instrument using the Diagnostic Wizard.
Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:
· The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of pXO I and pXO2 targets either from cultures or from direct blood specimens.
· The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
· The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
· The definitive identification of B. anthracisfrom colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071188: Modification to Jbaids Anthrax Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071188
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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