510(k) Report

FDA applicant

Microbiologics, Inc.

St. Cloud, MN18 decisions1995–20191 recall

FDA records 18 decisions for Microbiologics, Inc. (St. Cloud, MN) from 1995 to 2019: 18 510(k) clearances. Most are in product codes PMN (Assayed External Control Material For…) and JTO (Discs, Strips And Reagents, Microorganism…). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 71 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. 1 recall is 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 Microbiologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2019

2018: 32019: 5
2007high 5 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Microbiologics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microbiologics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays8decisions
  • JTODiscs, Strips And Reagents, Microorganism Differentiation7decisions
  • JSPKit, Anaerobic Identification3decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 71 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. · 20184cite it
  • K181683BD MAX CT/GC/TV 20-Day QC PanelMicrobiologics, Inc. · 20181cites it

What has FDA decided for it lately?

  • K190086Cepheid Xpert Respiratory Control PanelMicrobiologics, Inc. · 2019
  • K191168Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc. · 2019
  • K191172Cepheid Xpert MRSA NxG Control PanelMicrobiologics, Inc. · 2019
  • K190223Cepheid Xpert CT/NG Control PanelMicrobiologics, Inc. · 2019
  • K190463Cepheid Xpert C. difficile/Epi Control PanelMicrobiologics, Inc. · 20191 recall
  • K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. · 2018
  • K181683BD MAX CT/GC/TV 20-Day QC PanelMicrobiologics, Inc. · 2018
  • K181711BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelMicrobiologics, Inc. · 2018

All 18 as Microbiologics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K190463Cepheid Xpert C. difficile/Epi Control PanelMay 16, 2019Class III