510(k) · Cleared
ClearedGram Positive Autoidentification Plates, Sensititre AP90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accumed Intl., Inc. · LQL Gram Positive Identification Panel
Cleared on Jan 22, 1998 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 22, 1998
- Review
- 196 days
- Class
- Class I
- Product code
- LQL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQL? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 LQL devicesLQL Gram Positive Identification Panel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQL
FDA has decided no LQL device since 2007.
Median 510(k) review, days · LQL
Too few LQL 510(k)s in any year since 2007 to give a median.
Recalls per year · LQL
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQL
23in 2025
MAUDE reports naming product code LQL, not matched to any one device; reports are not rates.
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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 1 | 89 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 2 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972576: Gram Positive Autoidentification Plates, Sensititre AP90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972576
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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