Cleared Traditional

K945961 - CALCITONIN IMMUNOASSAY KIT

K945961 is an FDA 510(k) clearance for CALCITONIN IMMUNOASSAY KIT, 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 348-day FDA review.

K945961 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K945961

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
Combination Product No
PCCP Authorized No
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.

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 K945961.
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · Sangui Biotech, Inc. · Sep 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · Scantibodies Laboratory, Inc. · May 1996
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
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · Diagnostic Products Corp. · Jun 1986