Cleared Traditional

K182012 - ADVIA Centaur Calcitonin (CALCT) assay

K182012 is the FDA 510(k) clearance for ADVIA Centaur Calcitonin (CALCT) assay by Axis-Shield Diagnostics Limited. It is a Class 2 Chemistry device (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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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

Submission Details

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.

Device Classification

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 11
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
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997
CALCITONIN IMMUNOASSAY KIT
K945961 · Nichols Institute Diagnostics · Nov 1995
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · Diagnostic Systems Laboratories, Inc. · Jan 1992