510(k) · Cleared
ClearedImmulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · KLB Radioimmunoassay, Tobramycin
Cleared on Aug 20, 2001 as substantially equivalent to K941614 (Abbott Laboratories, 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
- KLB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941614 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941614 Axsym TobramycinAbbott Laboratories · 1994
- This deviceK012312 Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600…Diagnostic Products Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941614 | Axsym Tobramycin | Abbott Laboratories | 1994 | — |
| 0 (this device) | K012312 | Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (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 KLB? 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 |
|---|---|---|---|
| * | K941614 | Axsym TobramycinSummary page 2…geles, CA 90045-5597 Establishment Registration #: DPC's establishment Registration No. is 2017183 Substantially Equivalent Predicate Device: Abbott AxSYM® Tobramycin (K941614) Description of Device: IMMULITE® 2000 Tobramycin is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULI… | 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 no recall.
How does its category compare?
All KLB devicesKLB Radioimmunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLB
FDA has decided no KLB device since 2007.
Median 510(k) review, days · KLB
Too few KLB 510(k)s in any year since 2007 to give a median.
Recalls per year · KLB
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLB
1in 2024
MAUDE reports naming product code KLB, 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 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 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 tobramycin 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/K012312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012312: Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012312
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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