Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Focus Diagnostics, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
238 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Pos | Focus Diagnostics, Inc. | 2015-09-21 | 27 | 1 |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positi | Focus Diagnostics, Inc. | 2015-03-18 | 85 | 1 |
| K120986 | STRATIFY JCV DXSELECT | Focus Diagnostics, Inc. | 2012-08-16 | 136 | 1 |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITI | Focus Diagnostics, Inc. | 2012-07-13 | 154 | 2 |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Focus Diagnostics, Inc. | 2012-04-04 | 135 | 0 |
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | Focus Diagnostics, Inc. | 2012-01-20 | 14 | 0 |
| K102170 | SIMPLEXA FLU A/B & RSV | Focus Diagnostics, Inc. | 2010-11-24 | 114 | 0 |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | Focus Diagnostics, Inc. | 2010-10-29 | 74 | 0 |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | Focus Diagnostics, Inc. | 2010-05-24 | 125 | 0 |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | 2008-08-04 | 245 | 0 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | 2008-07-28 | 238 | 0 |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MO | Focus Diagnostics, Inc. | 2007-10-05 | 123 | 0 |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODEL | Focus Diagnostics, Inc. | 2007-09-24 | 112 | 0 |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | Focus Diagnostics, Inc. | 2007-02-01 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda