Column Chromatography & Color Development, Hydroxyproline
FDA product code JMM · Class I (low risk) · 21 CFR 862.1400 · Clinical Chemistry
21510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Ostex Intl., Inc. 5
- Metra Biosystems, Inc. 5
- Diagnostic Products Corp. 2
- Organon, Inc. 1
- Diagnostic Systems Laboratories, Inc. 1
- Ciba Corning Diagnostics Corp. 1
- Bayer Corp. 1
- Devices and Diagnostics Consulting Group 1
- Ortho-Clinical Diagnostics 1
- Osteometer Biotech A/S 1
- Metrika, Inc. 1
- Roche Diagnostics Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011052 | Osteomark NTX Point of Care Prescription Home UseJMM · Traditional | Ostex Intl., Inc. | 07/30/2001SE |
| K993706 | Elecsys Serum B-Crosslaps/Serum ImmunoassayJMM · Traditional | Roche Diagnostics Corp. | 07/24/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | Metrika, Inc. | 11/09/1999SE |
| K990843 | Serum Crosslaps One Step ElisaJMM · Traditional | Osteometer Biotech A/S | 07/09/1999SE |
| K983457 | Osteomark NTX Serum EiaJMM · Traditional | Ostex Intl., Inc. | 02/02/1999SE |
| K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsJMM · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/29/1999SE |
| K972788 | Crosslaps ElisaJMM · Traditional | Devices and Diagnostics Consulting Group | 12/22/1998SE |
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 08/13/1998SE |
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
| K974260 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 01/26/1998SE |
| K972580 | Deoxypyridinoline Assay for the Bayer Immuno 1 SystemJMM · Traditional | Bayer Corp. | 09/22/1997SE |
| K971312 | Immulite Pyrilinks-DJMM · Traditional | Diagnostic Products Corp. | 05/27/1997SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | Ciba Corning Diagnostics Corp. | 10/15/1996SE |
| K961562 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 07/11/1996SE |
| K960171 | Active Crosslaps ElisaJMM · Traditional | Diagnostic Systems Laboratories, Inc. | 03/28/1996SE |
| K952320 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 12/29/1995SE |
| K952506 | Pyrilinks Assay KitJMM · Traditional | Metra Biosystems, Inc. | 11/03/1995SE |
| K952026 | Pyrilinks Polyclonal Assay KitJMM · Traditional | Metra Biosystems, Inc. | 11/03/1995SE |
| K945946 | Osteomark(R)JMM · Traditional | Ostex Intl., Inc. | 05/08/1995SE |
| K770603 | Hypronosticon TMJMM · Traditional | Organon, Inc. | 09/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1727-2013 Class II | B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in…Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the… | Roche Diagnostics Operations, Inc. | 04/25/2013Terminated |
| Z-0039-2013 Class II | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | Immunodiagnostics Systems Ltd | 08/10/2012Terminated |