# K030370: Redline Anthrax Alert Test

- Pathway: 510(k) (Traditional)
- Applicant: Tetracore, Inc.
- Decided: Dec 9, 2003 after 308 days
- Product code: NPO (Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Antibody-conjugate for the detection of Anthrax antigen: named in the summary without a submission number

## Indications for use
The Tetracore RedLine Alert TM Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from non-hemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis. Warning: The RedLine Alert TM Test has not been evaluated for use with spore preparations, suspicious powders, or samples other than colonies from culture growth.

Source page: https://510kreport.com/device/K030370
Methodology: https://510kreport.com/methodology