Cleared Traditional

K182012 - ADVIA Centaur Calcitonin (CALCT) assay

K182012 is an FDA 510(k) clearance for ADVIA Centaur Calcitonin (CALCT) assay, manufactured by Axis-Shield Diagnostics Limited. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K182012 · Axis-Shield Diagnostics Limited · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
147d
Days
Class 2
Risk

K182012 is an FDA 510(k) clearance for the ADVIA Centaur Calcitonin (CALCT) assay. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on December 21, 2018 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1140 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Axis-Shield Diagnostics Limited devices

FDA 510(k) Submission Details - K182012

510(k) Number K182012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKR Device Classification - Class 2, Special Controls

Product Code JKR Radioimmunoassay, Calcitonin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1140
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JKR Radioimmunoassay, Calcitonin

All 15
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K182012.
Elecsys Calcitonin
K252431 · Roche Diagnostics GmbH · Apr 2026
ELECSYS CALCITONIN
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