510(k) · Cleared
ClearedARCHITECT iGentamicin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LCD Enzyme Immunoassay, Gentamicin
Cleared on Jul 9, 2025 as substantially equivalent to K102699 (Abbott Laboratories, 2011) after a 239-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jul 9, 2025
- Review
- 239 days
- Class
- Class II
- Product code
- LCD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935376 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LCD? 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 |
|---|---|---|---|
| * | K102699 | Architect Igentamicin Reagents; Architect Igentamicin CalibratorsSummary page 6…Classification Name: Gentamicin test system Governing Regulation: 862.3450 Product Code: LCD IV. Predicate Device ARCHITECT iGentamicin (k102699) V. Intended Use of the Device The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassa… | 2011 |
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?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 16.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LCD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCD
Too few LCD 510(k)s in any year since 2007 to give a median.
Recalls per year · LCD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCD
2in 2024
MAUDE reports naming product code LCD, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 3 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243500: ARCHITECT iGentamicin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243500
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026