510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Cedia (R) Tobramycin Assay

K912143510(k) TraditionalCleared Jul 26, 199172-day reviewClass II21 CFR 862.3900Recalls 2

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

Microgenics Corp. · LFW Fluorescence Polarization Immunoassay, Tobramycin

Cleared on Jul 26, 1991 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Jul 26, 1991
Review
72 days
Class
Class II
Product code
LFW
Recalls
2
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK912143 Cedia (R) Tobramycin AssayMicrogenics Corp. · 1991
  2. Descendant · cites it directly · 0 of its ownK963191 Cedia Antibiotic TDM Multi-CalsBoehringer Mannheim Corp. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K963191Cedia Antibiotic TDM Multi-CalsBoehringer Mannheim Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912143Cedia (R) Tobramycin AssayMicrogenics Corp.1991—
+1K963191Cedia Antibiotic TDM Multi-CalsBoehringer Mannheim Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K912143, 1991–1996Source: 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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
K963191Cedia Antibiotic TDM Multi-CalsBoehringer Mannheim Corp.19960

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 16, 2013Class IIZ-0513-2014Under Investigation by firmMicrogenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
Feb 10, 2006Not classifiedZ-0574-06OtherMay have tobramycin over-recovery at the trough level.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963191 (Boehringer Mannheim Corp., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LFW devices

LFW Fluorescence Polarization Immunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFW

FDA has decided no LFW device since 2007.

Median 510(k) review, days · LFW

Too few LFW 510(k)s in any year since 2007 to give a median.

Recalls per year · LFW

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LFW

No MAUDE report names LFW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—10
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Microgenics Corp.

107 FDA decisions under this applicant name. See the company

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  • K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp. · 20113 recalls
  • K101745Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011

Recent decisions in LFW

The LFW category page

  • K964670Roche Cobas-FP Reagents for TobramycinRoche Diagnostic Systems, Inc. · 1997
  • K944371Tobramycin Fpia Reagent Set and CalibratorSigma Diagnostics, Inc. · 1994
  • K941614Axsym TobramycinAbbott Laboratories · 1994
  • K900707Modified Accufluor Tobramycin Reagent & CalibratorInnotron of Oregon, Inc. · 1990
  • K894531FPR Tobramycin KitColony Laboratories, Inc. · 1989

https://510kreport.com/device/K912143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912143: Cedia (R) Tobramycin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912143

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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