510(k) · Cleared
Recalled · Class II · 2020Architect Igentamicin Reagents; Architect Igentamicin Calibrators
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 Apr 1, 2011 as substantially equivalent to K935376 (Abbott Mfg., Inc., 1994) after a 193-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 1, 2011
- Review
- 193 days
- Class
- Class II
- Product code
- LCD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935376 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243500ARCHITECT iGentamicinAbbott Laboratories · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935376 | Axsym Gentamicin | Abbott Mfg., Inc. | 1994 | 1 |
| 0 (this device) | K102699 | Architect Igentamicin Reagents; Architect Igentamicin Calibrators | Abbott Laboratories | 2011 | — |
| +1 | K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 LCD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCD device
- #1 K243500 ARCHITECT iGentamicinscore 9.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K935376 | Axsym GentamicinSummary page 1…sification: Class 11 Classification Panel: Clinical Toxicology Code: DL.! Legally marketed device to which equivalency is claimed: AxSYM Gentamicin (K935376) ARCHITECT iGentamicin Page I of 3 Admin 3.0 Summary… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicin | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2020 | Class II | Z-2117-2020 | Under Investigation by firm | Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Reagents:
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 i System 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.
Calibrators:
The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102699: Architect Igentamicin Reagents; Architect Igentamicin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102699
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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