ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
FDA 510(k) clearance K050231 · decided 2005-07-06
Clearance details
- K-number
- K050231
- Device name
- ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-26
- Decision date
- 2005-07-06
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products Insulin Calibrators (K171168) | Ortho Clinical Diagnostics | 2017-05-16 |
| CalSet IGF-1 (K170938) | Roche Diagnostics | 2017-04-26 |
| Abbott ARCHITECT Free T3 (K170160) | Abbott Laboratories | 2017-02-15 |
| Lumipulse G FSH-N Calibrators (K163534) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Progesterone-N Calibrators (K163546) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Prolactin (K163544) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Lumipulse G LH Calibrators (K163521) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| DC-UIBC-CAL (K163078) | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| Lumipulse G E2-III Calibrators (K163053) | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538) | Siemens Healthcare Diagnostics | 2016-11-17 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for m recall (Z-1444-2020) | Roche Diagnostics Operations, Inc. | 2020-03-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S046) | Roche Diagnostics Corp. | 2026-04-29 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S045) | Roche Diagnostics Corp. | 2026-04-29 |
| Elecsys total PSA assay (P990056/S045) | Roche Diagnostics Corp. | 2026-02-27 |
| Elecsys free PSA assay (P000027/S044) | Roche Diagnostics Corp. | 2026-02-27 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |