Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LEH · Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
151 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (V | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 | 361 | 0 |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-04-27 | 90 | 0 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | 2016-01-08 | 151 | 0 |
| K123947 | ARCHITECT IVANCOMYCIN | Biokit, S.A. | 2013-08-29 | 251 | 0 |
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CAL | Biokit, S.A. | 2008-03-19 | 238 | 1 |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Diagnostic Products Corp. | 2006-12-05 | 62 | 0 |
| K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN | Roche Diagnostics Corp. | 2006-05-11 | 65 | 2 |
| K050419 | QMS VANCOMYCIN | Seradyn, Inc. | 2005-04-01 | 42 | 1 |
| K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AN | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 | 60 | 2 |
| K032811 | CEDIA VANCOMYCIN ASSAY | Microgenics Corp. | 2003-11-24 | 76 | 0 |
| K020692 | EMIT 2000 VANCOMYCIN ASSAY | Dade Behring, Inc. | 2002-05-10 | 67 | 0 |
| K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOM | Beckman Coulter, Inc. | 2001-12-12 | 89 | 1 |
| K983280 | VANCOMYCIN EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-06 | 49 | 0 |
| K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1997-01-13 | 59 | 0 |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | 24 | 0 |
| K955851 | AXSYM VANCOMYCIN II | Abbott Laboratories | 1996-05-09 | 134 | 0 |
| K955716 | VANCOMYCIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1996-02-16 | 63 | 0 |
| K953528 | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN | Roche Diagnostic Systems, Inc. | 1995-09-12 | 47 | 0 |
| K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-19 | 104 | 0 |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | The DU Pont Co. | 1995-03-10 | 142 | 0 |
| K940595 | AXSYM VANCOMYCIN | Abbott Laboratories | 1994-06-21 | 131 | 0 |
| K924957 | OPUS(R) VANCOMYCIN | Pb Diagnostic Systems, Inc. | 1992-12-11 | 72 | 0 |
| K901759 | COBAS-FP REAGENTS FOR VANCOMYCIN | Roche Diagnostic Systems, Inc. | 1990-05-02 | 14 | 0 |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-19 | 66 | 0 |
| K892900 | ACA VANCOMYCIN (VANC) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-05-22 | 32 | 0 |
| K881040 | EMIT VANCOMYCIN ASSAY | Syva Co. | 1988-04-19 | 39 | 0 |
| K874438 | STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1988-01-21 | 85 | 0 |
| K872579 | INNOFLUOR VANCOMYCIN REAGENT SET | Innotron of Oregon, Inc. | 1987-08-17 | 48 | 0 |
| K822308 | VANCOMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-16 | 13 | 0 |
| K821136 | TDX TM STREPTOMYCIN | Abbott Laboratories | 1982-05-13 | 23 | 0 |
| K813218 | TDX VANCOMYCIN | Abbott Laboratories | 1981-12-08 | 29 | 1 |
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