510(k) Report

FDA applicant

Focus Diagnostics, Inc.

Cypress, CA18 decisions2007–20157 recalls

FDA records 18 decisions for Focus Diagnostics, Inc. (Cypress, CA) from 2007 to 2015: 16 510(k) clearances and 2 De Novo grants. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and MXJ (Enzyme Linked Immunosorbent Assay, Herpes…). Its devices cite 18 predicates, 3 of them its own earlier devices. 7 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Focus Diagnostics”.

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 Focus Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2015

2007: 32008: 22010: 32012: 42014: 32015: 3
2007high 4 (2012) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2014: 22015: 12016: 3, 2 Class I2020: 1
2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Focus Diagnostics, 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?

  • OCCRespiratory Virus Panel Nucleic Acid Assay System4decisions
  • MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-13decisions
  • PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel2decisions
  • OYPAnti-Jcv Antibody Detection Assay2decisions
  • LJNAntibody Igm, If, Epstein-Barr Virus1decision
  • OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And…1decision

Also: OOI (1), LSE (1), OMN (1), PGX (1), OQO (1).

Whose devices does it build on?

Its devices cite 18 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics · 20142cite it
  • K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20122cite it
  • K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 20102cite it
  • K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics · 20141cites it
  • K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc. · 20151cites it

What has FDA decided for it lately?

  • K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20151 recall
  • K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics · 20151 Class I recall
  • K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc. · 20151 Class I recall
  • K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics · 2014
  • K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 20141 Class I recall
  • DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics · 2014
  • K120986Stratify JCV DxselectFocus Diagnostics, Inc. · 20121 recall
  • K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20122 recalls

All 14 as Focus Diagnostics, Inc. →All 4 as Focus Diagnostics →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K141458MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs…May 12, 2020Class II
  • K141458Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452…Feb 10, 2016Class I
  • K152408Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451…Feb 10, 2016Class II
  • K143651Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451…Feb 10, 2016Class I
  • K120986STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus…Mar 15, 2015Class II
  • K120413Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu…May 15, 2014Class II

Other applicant names beginning “Focus”

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

Focus Medical, LLC 10Focus Technologies, Inc. 5Focus International, Inc. 1Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC 1Focus Surgery, Inc. 1