510(k) Report

FDA applicant

Luminex Corporation

Austin, TX18 decisions2008–202611 recalls

FDA records 18 decisions for Luminex Corporation (Austin, TX) from 2008 to 2026: 18 510(k) clearances. Most are in product codes NSU (Instrumentation For Clinical Multiplex Test…) and OOI (Real Time Nucleic Acid Amplification System). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.

FDA’s records also spell it “Luminex Corp.”.

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 Luminex Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 12013: 12014: 12015: 22016: 42017: 32019: 12024: 22025: 22026 (partial year): 1
2008high 4 (2016) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2021

2017: 12018: 12019: 72021: 2
2008high 7 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Luminex Corporation by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • NSUInstrumentation For Clinical Multiplex Test Systems3decisions
  • OOIReal Time Nucleic Acid Amplification System3decisions
  • PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous…1decision
  • OZZBordetella Pertussis Dna Assay System1decision
  • OCCRespiratory Virus Panel Nucleic Acid Assay System1decision
  • PAMGram-Positive Bacteria And Their Resistance Markers1decision

Also: NQX (1), QOF (1), PGX (1), NJR (1), PEN (1), OZN (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 120 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV…Luminex Corporation · 20151cites it
  • K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation · 20171cites it
  • K073506Luminex LX 100/200 InstrumentLuminex Corp. · 20081cites it

What has FDA decided for it lately?

  • K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026
  • K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation · 2025
  • K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation · 2025
  • K240627LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation · 2024
  • K233410LIAISON PLEX Respiratory Flex AssayLuminex Corporation · 2024
  • K191742ARIES MRSA AssayLuminex Corporation · 2019
  • K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation · 20171 recall
  • K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay…Luminex Corporation · 20171 recall

All 15 as Luminex Corporation →All 3 as Luminex Corp. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K161495ARIES HSV 1&2 Assay, Catalog/REF# 50-10017Nov 17, 2021Class II
  • K161495ARIES HSV 1&2 Assay, Part Number/REF 50-10017Apr 16, 2021Class II
  • K160517ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073Feb 20, 2019Class II
  • K172402ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469Feb 20, 2019Class II
  • K163626Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452Feb 20, 2019Class II
  • K171441ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059Feb 20, 2019Class II

Other applicant names beginning “Luminex”

FDA records each applicant name separately; these may or may not be the same firm.

Luminex Molecular Diagnostics, Inc. 26