ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
FDA 510(k) clearance K993706 · decided 2000-07-24
Clearance details
- K-number
- K993706
- Device name
- ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-02
- Decision date
- 2000-07-24
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- JMM
- Device class
- 1
- Regulation number
- 862.1400
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| OSTEOMARK NTX POC (K992997) | Metrika, Inc. | 1999-11-09 |
| SERUM CROSSLAPS ONE STEP ELISA (K990843) | Osteometer Biotech A/S | 1999-07-09 |
| OSTEOMARK NTX SERUM EIA (K983457) | Ostex Intl., Inc. | 1999-02-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| CROSSLAPS ELISA (K972788) | Devices and Diagnostics Consulting Group | 1998-12-22 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833) | Diagnostic Products Corp. | 1998-05-01 |
| OSTEOMARK (K980518) | Ostex Intl., Inc. | 1998-03-06 |
| PYRILINKS-D ASSAY KIT (K974260) | Metra Biosystems, Inc. | 1998-01-26 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| IMMULITE PYRILINKS-D (K971312) | Diagnostic Products Corp. | 1997-05-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro recall (Z-1727-2013) | Roche Diagnostics Operations, Inc. | 2013-07-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |