510(k) · Cleared
ClearedIndx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to Orientia Tsutsugamushi (Scrub Typhus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
David C. Bishop, Ph.D. · LSQ Reagent, Rickettsia Serological
Cleared on Mar 13, 1998 after a 316-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 13, 1998
- Review
- 316 days
- Class
- Class I
- Product code
- LSQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 LSQ? 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 |
|---|---|---|---|
| * | — | INDX Indirect Immunofluorescence (IFA) Slide Test for the Detection of Antibodies to… Named without a submission number |
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.
How does its category compare?
All LSQ devicesLSQ Reagent, Rickettsia Serological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSQ
FDA has decided no LSQ device since 2007.
Median 510(k) review, days · LSQ
Too few LSQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LSQ
No recall names LSQ since 2007.
Adverse event reports per year · LSQ
No MAUDE report names LSQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971591: Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to Orientia Tsutsugamushi (Scrub Typhus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971591
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026