# K192871: B. anthracis Real-time PCR Assay

- Pathway: 510(k) (Special)
- Applicant: Centers for Disease Control and Prevention
- Decided: Nov 7, 2019 after 30 days
- Product code: NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis)
- Device class: 2
- Regulation: 21 CFR 866.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922906 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140426: Anthracis Real-Time PCR Assay, Centers For Disease Control and Prevention (CDC) (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K192871
Methodology: https://510kreport.com/methodology