Cleared Traditional

K060578 - CALCITONIN IMMUNORADIOMETRIC ASSAY (IRM...

K060578 is an FDA 510(k) clearance for CALCITONIN IMMUNORADIOMETRIC ASSAY (IRM..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K060578 · Scantibodies Laboratory, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
177d
Days
Class 2
Risk

K060578 is an FDA 510(k) clearance for the CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION). Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on August 30, 2006 after a review of 177 days - an extended review cycle.

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 Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K060578

510(k) Number K060578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2006
Decision Date August 30, 2006
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 88d · This submission: 177d
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 13
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K060578.
Elecsys Calcitonin
K252431 · Roche Diagnostics GmbH · Apr 2026
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · Axis-Shield Diagnostics Limited · Dec 2018
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
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · Scantibodies Laboratory, Inc. · May 1996