Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PGI — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
242 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233349 | Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. | 2024-05-03 | 217 | 0 |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, | Quidel Corporation | 2023-12-20 | 141 | 0 |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019-11-26 | 88 | 1 |
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Elitechgroup | 2018-10-29 | 242 | 0 |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Contr | Diasorin Molecular, LLC | 2018-03-14 | 90 | 0 |
| K162451 | Solana HSV 1+2/VZV Assay | Quidel Corporation | 2016-11-28 | 88 | 0 |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HS | Luminex Corporation | 2015-10-06 | 85 | 1 |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1 | Meridian Bioscience, Inc. | 2015-07-17 | 88 | 0 |
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | Diagnostic Hybrids, Inc. | 2014-05-13 | 81 | 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