Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NDY — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
265 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | 2025-05-16 | 259 | 0 |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 | 31 | 0 |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 | 32 | 0 |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016-07-27 | 26 | 0 |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN | Roche Diagnostics | 2014-07-17 | 76 | 0 |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | Diazyme Laboratories | 2012-03-30 | 290 | 0 |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | 2010-09-28 | 358 | 0 |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | 2010-09-14 | 265 | 0 |
| K093680 | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | 2010-04-08 | 132 | 0 |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN | Siemens Healthcare Diagnostics | 2009-03-11 | 71 | 0 |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2008-08-20 | 49 | 0 |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYST | Roche Diagnostics Corp. | 2008-06-20 | 88 | 0 |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | 2008-06-06 | 114 | 0 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | 2008-05-15 | 66 | 0 |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A | Diazyme Laboratories | 2008-02-01 | 170 | 0 |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | 2008-01-24 | 171 | 0 |
| K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | 2007-11-06 | 172 | 0 |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Thermo Electron OY | 2007-03-12 | 95 | 0 |
| K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIB | Dade Behring, Inc. | 2007-01-22 | 77 | 0 |
| K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Dako A/S | 2004-09-03 | 79 | 0 |
| K041878 | N LATEX CYSTATIN | Dade Behring, Inc. | 2004-08-16 | 35 | 0 |
| K003503 | N LATEX CYSTATIN C | Dade Behring, Inc. | 2001-03-13 | 120 | 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