Cleared Traditional

K964635 - NICHOLS ADVANTAGE CHEMILUMINESCENCE CAL...

K964635 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE CAL... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code JKR) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K964635 · Nichols Institute Diagnostics · Chemistry device
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May 1997
Decision
183d
Days
Class 2
Risk

K964635 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN 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 May 21, 1997 after a review of 183 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K964635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1996
Decision Date May 21, 1997
Days to Decision 183 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
95d slower than avg
Panel avg: 88d · This submission: 183d
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 K964635.
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
CALCITONIN IMMUNOASSAY KIT
K945961 · Nichols Institute Diagnostics · Nov 1995
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · Diagnostic Systems Laboratories, Inc. · Jan 1992
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · Diagnostic Systems Laboratories, Inc. · Feb 1988