ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY— 510(k) K993706

Clearance details

Applicant

Roche Diagnostics Corp.

Product code

Code JMM

Device class

Class 1

Regulation

21 CFR 862.1400

Advisory panel

Clinical Chemistry

Date received

1999-11-02

Decision date

2000-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

• K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE2001-07-30
• K992997 — OSTEOMARK NTX POC1999-11-09
• K990843 — SERUM CROSSLAPS ONE STEP ELISA1999-07-09
• K983457 — OSTEOMARK NTX SERUM EIA1999-02-02
• K983674 — VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS1999-01-29

• K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
• K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
• K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
• K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
• K093664 — AMPHETAMINES II ASSAY2010-07-28

• Z-1727-2013 — B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.Class II·Terminated·Roche Diagnostics Operations, Inc.·20130425

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993706.