Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJH — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
265 daysmedian FDA review time
490 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020-03-05 | 307 | 0 |
| K163273 | TRU Legionella | Meridian Bioscience, Inc. | 2017-02-21 | 92 | 0 |
| K113190 | TRU LEGIONELLA | Meridian Bioscience, Inc. | 2012-02-24 | 116 | 0 |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Sa Scientific , Ltd. | 2007-06-28 | 393 | 0 |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, | Inverness Medical Professional Diagnostics | 2007-03-15 | 20 | 0 |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Trinity Biotech USA | 2003-11-26 | 58 | 0 |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | Intracel Corp. | 1999-12-21 | 265 | 1 |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND | Binax, Inc. | 1998-08-21 | 57 | 1 |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | Binax, Inc. | 1994-09-20 | 340 | 0 |
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Whittaker Bioproducts, Inc. | 1992-07-30 | 490 | 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