Cleared Traditional

K964635 - NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT

K964635 is an FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE CAL..., manufactured by Nichols Institute Diagnostics. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K964635

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.

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 15
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K964635.
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
CALCITONIN
K990073 · Kmi Diagnostics, Inc. · May 1999
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · Sangui Biotech, Inc. · Sep 1998
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · Scantibodies Laboratory, Inc. · May 1996
CALCITONIN IMMUNOASSAY KIT
K945961 · Nichols Institute Diagnostics · Nov 1995
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · Diagnostic Systems Laboratories, Inc. · Jan 1992