Cleared Traditional

K961043 - SCANTIBODIES CALCITONIN IMMUNORADIOMETR...

K961043 is an FDA 510(k) clearance for SCANTIBODIES CALCITONIN IMMUNORADIOMETR..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K961043 · Scantibodies Laboratory, Inc. · Chemistry device
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May 1996
Decision
53d
Days
Class 2
Risk

K961043 is an FDA 510(k) clearance for the SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY). Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 53 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 Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K961043

510(k) Number K961043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date May 06, 1996
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 13
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K961043.
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · Scantibodies Laboratory, Inc. · Aug 2006
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp. · Dec 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997
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