510(k) · Cleared
Recalled · Class II · 2022Immunocard Stat! Rotavirus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Diagnostics, Inc. · LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Cleared on Aug 20, 1997 after a 111-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Aug 20, 1997
- Review
- 111 days
- Class
- Class I
- Product code
- LIQ
- Recalls
- 1
- 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 LIQ? 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? (2)
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 |
|---|---|---|---|
| * | — | Premier Rotaclone Named without a submission number | |
| * | — | Abbott Test Pack EIA 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2022 | Class II | Z-0678-2022 | Storage | The product was incorrectly shipped at room temperature rather than refrigerated. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LIQ devicesLIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIQ
FDA has decided no LIQ device since 2007.
Median 510(k) review, days · LIQ
Too few LIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LIQ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIQ
No MAUDE report names LIQ 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 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.
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/K971585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971585: Immunocard Stat! Rotavirus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971585
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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