JMM · Column Chromatography & Color Development, Hydroxyproline
Clinical Chemistry · 21 CFR 862.1400 · Class 1
Overview
| Product Code | JMM |
|---|---|
| Device Name | Column Chromatography & Color Development, Hydroxyproline |
| Regulation | 21 CFR 862.1400 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | Ostex Intl., Inc. | Jul 30, 2001 | SESE |
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | Roche Diagnostics Corp. | Jul 24, 2000 | SESE |
| K992997 | OSTEOMARK NTX POC | Metrika, Inc. | Nov 9, 1999 | SESE |
| K990843 | SERUM CROSSLAPS ONE STEP ELISA | Osteometer Biotech A/S | Jul 9, 1999 | SESE |
| K983457 | OSTEOMARK NTX SERUM EIA | Ostex Intl., Inc. | Feb 2, 1999 | SESE |
| K983674 | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS | Ortho-Clinical Diagnostics, Inc. | Jan 29, 1999 | SESE |
| K972788 | CROSSLAPS ELISA | Devices and Diagnostics Consulting Group | Dec 22, 1998 | SESE |
| K981364 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | Aug 13, 1998 | SESE |
| K980833 | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 | Diagnostic Products Corp. | May 1, 1998 | SESE |
| K980518 | OSTEOMARK | Ostex Intl., Inc. | Mar 6, 1998 | SESE |
| K974260 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | Jan 26, 1998 | SESE |
| K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Sep 22, 1997 | SESE |
| K971312 | IMMULITE PYRILINKS-D | Diagnostic Products Corp. | May 27, 1997 | SESE |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Ciba Corning Diagnostics Corp. | Oct 15, 1996 | SESE |
| K961562 | OSTEOMARK | Ostex Intl., Inc. | Jul 11, 1996 | SESE |
| K960171 | ACTIVE CROSSLAPS ELISA | Diagnostic Systems Laboratories, Inc. | Mar 28, 1996 | SESE |
| K952320 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | Dec 29, 1995 | SESE |
| K952506 | PYRILINKS ASSAY KIT | Metra Biosystems, Inc. | Nov 3, 1995 | SESE |
| K952026 | PYRILINKS POLYCLONAL ASSAY KIT | Metra Biosystems, Inc. | Nov 3, 1995 | SESE |
| K945946 | OSTEOMARK(R) | Ostex Intl., Inc. | May 8, 1995 | SESE |
Top Applicants
- Metra Biosystems, Inc. — 5 clearances
- Ostex Intl., Inc. — 5 clearances
- Diagnostic Products Corp. — 2 clearances
- Bayer Corp. — 1 clearance
- Ciba Corning Diagnostics Corp. — 1 clearance
