Company ยท US
Focus Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2015. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 7 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 3 |
| OYP | Anti-Jcv Antibody Detection Assay | 3 |
| PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 3 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 |
| LSE | Epstein-Barr Virus, Other | 1 |
| NOP | Elisa, Antibody, West Nile Virus | 1 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 |
| OOC | 1 | |
| OOI | Real Time Nucleic Acid Amplification System | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 1 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 1 |
| OTT | Research Use Only/Microbiology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2015 | K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack Focus Diagnostics, Inc. | OCC |
| Aug 28, 2015 | K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack Focus Diagnostics | OQO |
| Mar 18, 2015 | K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack Focus Diagnostics, Inc. | PGX |
| Dec 5, 2014 | K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack Focus Diagnostics | OCC |
| Jul 1, 2014 | K141458 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK Focus Diagnostics | PGH |
| Mar 21, 2014 | DEN130049 | SIMPLEXA HSV 1&2 DIRECT Focus Diagnostics | PGH |
| Aug 16, 2012 | K120986 | STRATIFY JCV DXSELECT Focus Diagnostics, Inc. | OYP |
| Jul 13, 2012 | K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK Focus Diagnostics, Inc. | OCC |
| Apr 4, 2012 | K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT Focus Diagnostics, Inc. | OMN |
| Jan 20, 2012 | DEN120008 | STRATIFY JCV(TM) ANTIBODY Focus Diagnostics, Inc. | OYP |
| Nov 24, 2010 | K102170 | SIMPLEXA FLU A/B & RSV Focus Diagnostics, Inc. | OCC |
| Oct 29, 2010 | K102314 | 3M INTEGRATED CYCLER (110V) & (220V) Focus Diagnostics, Inc. | OOI |
| May 24, 2010 | K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 Focus Diagnostics, Inc. | OQW |
| Aug 4, 2008 | K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M Focus Diagnostics, Inc. | LJN |
| Jul 28, 2008 | K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G Focus Diagnostics, Inc. | LSE |
| Oct 5, 2007 | K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G Focus Diagnostics, Inc. | MXJ |
| Sep 24, 2007 | K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 Focus Diagnostics, Inc. | MXJ |
| Feb 1, 2007 | K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G Focus Diagnostics, Inc. | MXJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Focus Diagnostics Inc Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. Terminated |
LHL | None listed |
| Mar 27, 2017 | Focus Diagnostics Inc Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. Terminated |
LHL | None listed |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2850, MOL1451, MOL1452, MOL1455 Terminated |
PGX | K143651 |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2650, MOL1451, MOL1452, MOL1455 Terminated |
OCC | K152408 |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2150, MOL1451, MOL1452, MOL1455 Terminated |
PGH | K141458 K150962 |
| Nov 6, 2015 | Focus Diagnostics Inc Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic. Terminated |
OTT | None listed |
| Apr 17, 2015 | Focus Diagnostics Inc STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. Terminated |
OYP | K120986 |
| Jul 1, 2014 | Focus Diagnostics Inc Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650.
510(k) K120413 Simplexa" Flu A/B & RSV Direct.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Inte Terminated |
OCC | K120413 |
| Mar 5, 2014 | Focus Diagnostics Inc Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influen Terminated |
OOC | None listed |
| Jan 28, 2014 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct assay, Model MOL2650.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative d Terminated |
OCC | K120413 |
| Oct 31, 2012 | Focus Diagnostics Inc West Nile Virus IgG DxSelect" kit Catalog No. EL0300G
Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen
Wells, Catalog Number EL0351, Lot Number 121117.
510 Terminated |
NOP | K031953 |
| Aug 17, 2008 | Focus Diagnostics Inc HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G
Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. Terminated |
LGC | K000238 |