Cleared Traditional

CALCITONIN IMMUNOASSAY KIT (K945961) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945961 · Nichols Institute Diagnostics · Chemistry device
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Nov 1995
Decision
348d
Days
Class 2
Risk

K945961 is an FDA 510(k) clearance for the CALCITONIN IMMUNOASSAY KIT. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K945961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1994
Decision Date November 20, 1995
Days to Decision 348 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 88d · This submission: 348d
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 19
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K945961.
Elecsys Calcitonin
K252431 · Roche Diagnostics GmbH · Apr 2026
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · Axis-Shield Diagnostics Limited · Dec 2018
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · Diagnostic Products Corp. · Jun 1986