510(k) · Cleared
ClearedAMI™ Plasma Cartridge, AMI™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequitur Health Corp. · JID Photometric Method, Ammonia
Cleared on Sep 1, 2026 as substantially equivalent to K820723 (Eastman Kodak Company, 1982) and 1 other predicate after a 188-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Sep 1, 2026
- Review
- 188 days
- Class
- Class I
- Product code
- JID
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811919 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811919 Kodak Ektachem 400 AnalyzerEastman Kodak Company · 1981
- This deviceK260613 AMI™ Plasma Cartridge, AMI™Sequitur Health Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811919 | Kodak Ektachem 400 Analyzer | Eastman Kodak Company | 1981 | — |
| 0 (this device) | K260613 | AMI™ Plasma Cartridge, AMI™ | Sequitur Health Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
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 JID? 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 |
|---|---|---|---|
| * | K820723 | Kodak Ektachem Clinical Chem. NH3Summary page 5…1065 Product Code(s) JJE, JID I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K820723 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NH3) JID K811919 KODAK EKTACHEM 400 ANALYZER JJE Device Description Summary 21 CFR 807.… | 1982 |
| * | K811919 | Kodak Ektachem 400 AnalyzerSummary page 5…Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K820723 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NH3) JID K811919 KODAK EKTACHEM 400 ANALYZER JJE Device Description Summary 21 CFR 807.92(a)(4) The AMI™ completes an ammonia measurement through… | 1981 |
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.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JID devicesJID Photometric Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JID
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · JID
Too few JID 510(k)s in any year since 2007 to give a median.
Recalls per year · JID
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JID
6in 2025
MAUDE reports naming product code JID, 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 | 4 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 1 | 18 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AMI™ Plasma Cartridge is a photometric in vitro test for the quantitative determination of ammonia in human plasma on the AMI™ analyzer. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
The AMI™ is an analyzer for in vitro diagnostic use in clinical laboratories, utilizing photometric technology for analyte detection.
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/K260613 · printed Nov 3, 2026
Cite this page
510(k) Report. “K260613: AMI™ Plasma Cartridge, AMI™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260613
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026