510(k) Report

FDA applicant

Iquum, Inc.

Marlborough, MA3 decisions2011–20164 recalls

FDA records 3 decisions for Iquum, Inc. (Marlborough, MA) from 2011 to 2016: 3 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and PGX (Groups A, C And G Beta-Hemolytic Streptococcus…). Its devices cite 8 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Iquum, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12014: 12016: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015: 12016: 22021: 1
2011high 2 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Iquum, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OCCRespiratory Virus Panel Nucleic Acid Assay System2decisions
  • PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141338Liat Strep a AssayIquum, Inc. · 20145cite it
  • K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 20113cite it
  • K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. · 20161cites it

What has FDA decided for it lately?

  • K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. · 2016
  • K141338Liat Strep a AssayIquum, Inc. · 2014
  • K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc. · 20114 recalls

All 3 as Iquum, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K111387cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number…Nov 16, 2021Class II
  • K111387cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B…May 17, 2016Class III
  • K111387cobas¿ Liat¿ AnalyzerMay 9, 2016Class II
  • K111387cobas Liat Analyzer, for in vitro diagnostic use.Jul 24, 2015Class II