510(k) Report

510(k) · Cleared

Cleared

Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators

K003341510(k) TraditionalCleared Jan 22, 200189-day reviewClass II21 CFR 862.3900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Syva Co., Dade Behring, Inc. · KLB Radioimmunoassay, Tobramycin

Cleared on Jan 22, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 22, 2001
Review
89 days
Class
Class II
Product code
KLB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared200020052010201520202025
  1. This deviceK003341 Emit 2000 Tobramycin Assay Emit 2000 Tobramycin CalibratorsSyva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK043384 Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003341Emit 2000 Tobramycin Assay Emit 2000 Tobramycin CalibratorsSyva Co., Dade Behring, Inc.2001—
+1K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance…Ortho-Clinical Diagnostics, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K003341, 2001–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20050

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?

  • Of its descendants, K043384 (Ortho-Clinical Diagnostics, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLB devices

KLB 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

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KLB

1in 2024

2017: 12024: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code KLB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—20
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Syva Co., Dade Behring, Inc.

19 FDA decisions under this applicant name. See the company

  • K011920Emit 2000 Digoxin Assay, Model OSR4H229Syva Co., Dade Behring, Inc. · 2001
  • K011620Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229Syva Co., Dade Behring, Inc. · 2001
  • K011605Emit 2000 Quinidine Assay, Model OSR4Q229Syva Co., Dade Behring, Inc. · 20011 recall
  • K011300Emit II Plus Cannabinoid Assay, Model OSR9N229Syva Co., Dade Behring, Inc. · 2001
  • K011306Emit II Plus Benzodiazepine Assay, Model 0SR9F229Syva Co., Dade Behring, Inc. · 2001

Recent decisions in KLB

The KLB category page

  • K060853Online TDM TobramycinRoche Diagnostics Corp. · 20062 recalls
  • K012312Immulite 2000 Tobramycn, Models L2KTC2 (2002 Tests), L2KTC6 (600 Tests)Diagnostic Products Corp. · 2001
  • K904304Dupont Dimension (R) Tobramllycin (Tobr) MethodE.I. Dupont DE Nemours & Co., Inc. · 1990
  • K903192IL Tobramycin AssayInstrumentation Laboratory CO · 1990
  • K893913Technicon RA Systems Tobramycin Test MethodTechnicon Instruments Corp. · 1989

https://510kreport.com/device/K003341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003341: Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003341

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026