510(k) Report

510(k) · Cleared

Cleared

Cedia Cyclosporine Plus High Range Controls 4 and 5

K030616510(k) TraditionalCleared Mar 31, 200333-day reviewClass I21 CFR 862.3280

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

Microgenics Corp. · LAS Drug Specific Control Materials

Cleared on Mar 31, 2003 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Mar 31, 2003
Review
33 days
Class
Class I
Product code
LAS
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared200020052010201520202025
  1. This deviceK030616 Cedia Cyclosporine Plus High Range Controls 4 and 5Microgenics Corp. · 2003
  2. Descendant · cites it directly · 0 of its ownK032842 Microgenics Cyclosporine Control KitMicrogenics Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K032842Microgenics Cyclosporine Control KitMicrogenics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030616Cedia Cyclosporine Plus High Range Controls 4 and 5Microgenics Corp.2003—
+1K032842Microgenics Cyclosporine Control KitMicrogenics Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K030616, 2003–2003Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LAS? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K032842Microgenics Cyclosporine Control KitMicrogenics Corp.20030

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, K032842 (Microgenics Corp., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LAS devices

LAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAS

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAS

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

Recalls per year · LAS

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 · LAS

No MAUDE report names LAS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20091—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—

What is it indicated for?

The CEDIA@Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Indications for use as stated in the FDA 510(k) statement.

More from Microgenics Corp.

107 FDA decisions under this applicant name. See the company

  • K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 20131 recall
  • K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 20132 recalls
  • K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013
  • K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp. · 20113 recalls
  • K101745Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011

Recent decisions in LAS

The LAS category page

  • K080459Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009
  • K072257Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LevelMore Diagnostics · 2008
  • K062942Quantimetrix Nicosure Cotinine Urine ControlQuantimetrix Corp. · 2006
  • K051074Mas Immunosuppressant ControlsMicrogenics Corp. · 2005
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https://510kreport.com/device/K030616 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030616: Cedia Cyclosporine Plus High Range Controls 4 and 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030616

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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