Cleared Traditional

CALCITONIN RADIOIMMUNOASSAY KIT (K842907) - FDA 510(k) Clearance

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

K842907 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
43d
Days
Class 2
Risk

K842907 is an FDA 510(k) clearance for the CALCITONIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Walker, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K842907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1984
Decision Date September 05, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K842907.
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