510(k) · Cleared
ClearedImmulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LCD Enzyme Immunoassay, Gentamicin
Cleared on Aug 20, 2001 as substantially equivalent to K935376 (Abbott Mfg., Inc., 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 20, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- LCD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935376 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK935376 Axsym GentamicinAbbott Mfg., Inc. · 1994 · Recalled
- This deviceK012311 Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600…Diagnostic Products Corp. · 2001
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) | K012311 | Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests) | Diagnostic Products Corp. | 2001 | — |
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 2…eles, CA 90045-5597 Establishment Registration #: DPC's establishment Registration No. is 2017183 Substantially Equivalent Predicate Device: Abbott AxSYM® Gentamicin (K935376) Description of Device: IMMULITE® 2000 Gentamicin is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULIT… | 1994 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K935376.
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.
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/K012311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012311: Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012311
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026