510(k) · Cleared
ClearedB. anthracis Real-time PCR Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers for Disease Control and Prevention · NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Cleared on Nov 7, 2019 as substantially equivalent to K140426 (Centers For Disease Control and Prevention (CDC), 2014) after a 30-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Nov 7, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- NHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922906 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 6 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 5 generations backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- 4 generations backK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- 3 generations backK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
- 2 generations backK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
- 1 generation backK140426 Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014
- This deviceK192871 B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −6 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −5 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| −4 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| −3 | K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K192871 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K140426 | Anthracis Real-Time PCR AssaySummary page 4…on: (if applicable) detection; 21 CFR 866.3045 Predicate device(s): B. anthracis Real-time PCR Assay (K140426) Background Anthrax is a zoonotic disease caused by B. anthracis that is transmissible to humans through handli… | 2014 |
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 9 ancestors have a recall of any class.
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. 2019, 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 B. anthracis Real-Time PCR Assay is an in vitro diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from B. anthracis. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, cerebrospinal fluid, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax. Results generated from direct specimen testing are presumptive for the…
Read the full statement (178 words)
The B. anthracis Real-Time PCR Assay is an in vitro diagnostic test for the qualitative detection of plasmid and chromosomal DNA sequences from B. anthracis. The assay can be used to test human respiratory samples, whole blood, serum, plasma, swabs from lesions, cerebrospinal fluid, pleural fluid, and bacterial culture isolates from individuals suspected of having anthrax.
Results generated from direct specimen testing are presumptive for the identification of B. anthracis. Results generated from culture isolate testing should be used in conjunction with other conventional methods for identification of Bacillus anthracis isolates as part of the LRN Bacillus anthracis Testing Algorithm. The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidences, in addition to the identification of B. anthracis from cultures or detection directly in clinical specimens.
Use is limited to Laboratory Response Network (LRN) designated laboratories.
The B. anthracis Real-time PCR Assay is also intended for environmental specimen testing for biothreat detection and response. FDA has not evaluated claims related to the use of this assay on environmental specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192871: B. anthracis Real-time PCR Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192871
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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