Cleared Traditional

ADVIA Centaur Calcitonin (CALCT) assay

K182012 · Axis-Shield Diagnostics Limited · Chemistry
Dec 2018
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K182012 is an FDA 510(k) clearance for the ADVIA Centaur Calcitonin (CALCT) assay, a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR), submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on December 21, 2018, 147 days after receiving the submission on July 27, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number K182012 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2018
Decision Date December 21, 2018
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKR — Radioimmunoassay, Calcitonin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1140

Similar Devices — JKR Radioimmunoassay, Calcitonin

All 18
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
K132828 · Roche Diagnostics · Dec 2013
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · Scantibodies Laboratory, Inc. · Aug 2006
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
CALCITONIN
K990073 · Kmi Diagnostics, Inc. · May 1999
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · Sangui Biotech, Inc. · Sep 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997