# K143592: Gamma Phage Lysis Assay for the Identification of Bacillus Anthrac

- Pathway: 510(k) (Special)
- Applicant: The Surgeon General, Department of the Army
- Decided: Apr 16, 2015 after 119 days
- Product code: NVQ (Bacteriophage And Controls, B. Anthracis Lysis)
- 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: 1 generation back to K051794 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051794: Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis, Office of the Surgeon General, U.S. Army (2005) Summary page 5.

## Indications for use
The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, “ground-glass”- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors. Use of this assay is limited to designated laboratories within the Laboratory Response Network (LRN) and Department of Defense (D0D).

Source page: https://510kreport.com/device/K143592
Methodology: https://510kreport.com/methodology