# K971591: Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to Orientia Tsutsugamushi (Scrub Typhus)

- Pathway: 510(k) (Traditional)
- Applicant: David C. Bishop, Ph.D.
- Decided: Mar 13, 1998 after 316 days
- Product code: LSQ (Reagent, Rickettsia Serological)
- Device class: 1
- Regulation: 21 CFR 866.3500
- 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) INDX Indirect Immunofluorescence (IFA) Slide Test for the Detection of Antibodies to Rickettsial Species (O. tsutsugamushi): named in the summary without a submission number

## Indications for use
The INDX" Dip-S-Ticks® scrub typhus test is an enzyme immunoassay for usc as an aid in the diagnosis of scrub typhus, and detects total IgG and IgM antibodies to Orientia rsursugamushi. The Dip-S-Ticks test is qualitative when used to test a single specimen; when using paired specimens to detect sero-conversion the test may be semi-quantitative. The test is intended for use in serum as well as heparinized plasma, whole blood and finger-stick capillary blood and is intended to be performed by trained medical personnel only.

Source page: https://510kreport.com/device/K971591
Methodology: https://510kreport.com/methodology