510(k) Report

510(k) · Cleared

Cleared

Vitek Immunodiagnostic Assay System (Vidas)

K891385510(k) TraditionalCleared Apr 18, 198940-day reviewClass II21 CFR 866.5510

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

Vitek Systems, Inc. · DEW Igg, Antigen, Antiserum, Control

Cleared on Apr 18, 1989 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 18, 1989
Review
40 days
Class
Class II
Product code
DEW
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK891385 Vitek Immunodiagnostic Assay System (Vidas)Vitek Systems, Inc. · 1989
  2. Descendant · cites it directly · 2 of its ownK083518 Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009
  3. Descendant · 2 generations on · 0 of its ownK221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO · 2023
  4. Descendant · 2 generations on · 0 of its ownK170314 ACL AcuStarInstrumentation Laboratory CO · 2017
  5. Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO · 2009 · cites it directly2descendants
  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
  • K170314ACL AcuStarInstrumentation Laboratory CO · 2017 · 2 generations on0descendants
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891385Vitek Immunodiagnostic Assay System (Vidas)Vitek Systems, Inc.1989—
+1K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO2009—
+2K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO2023—
+2K170314ACL AcuStarInstrumentation Laboratory CO2017—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M…Biomerieux20154

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201510
201710
202310
FIG. 1 — Lineage of K891385, 1989–2023Source: 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 DEW? 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? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092
K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux20150

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, K083518 (Instrumentation Laboratory CO, 2009) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DEW devices

DEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEW

FDA has decided no DEW device since 2007.

Median 510(k) review, days · DEW

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

Recalls per year · DEW

1in 2024

2010: 12024: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DEW

4in 2024

2009: 42010: 22011: 162015: 22016: 42017: 62018: 12019: 92020: 192023: 12024: 4
2007high 19 (2020) · low 0 (2007)2025

MAUDE reports naming product code DEW, 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—00
20080—00
20090—04
20100—12
20110—016
20120—00
20130—00
20140—00
20150—02
20160—04
20170—06
20180—01
20190—09
20200—019
20210—00
20220—00
20230—01
20240—14
20250—00
20260—0—

More from Vitek Systems, Inc.

39 FDA decisions under this applicant name. See the company

  • K920661Vidas CMV Igg AssayVitek Systems, Inc. · 19931 recall
  • K921302Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 1992
  • K921176Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 19921 recall
  • K920952Vitek Immunodiag Assay Syst (Vidas) Ferritine AssayVitek Systems, Inc. · 1992
  • K915884Vidas Chlamydia Assay, ModificationVitek Systems, Inc. · 19921 recall

Recent decisions in DEW

The DEW category page

  • K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
  • K040434Roche Diagnostics Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2004
  • K010617Spife Ife Calibrator and Control KitHelena Laboratories · 2001
  • K993928Wako-Igg II-HA, Immunoglobulin Calibrator Set, Immunolobulin StandardWako Chemicals USA, Inc. · 2000
  • K993281K-Assay IggKamiya Biomedical Co. · 1999

https://510kreport.com/device/K891385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891385: Vitek Immunodiagnostic Assay System (Vidas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891385

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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