Cleared Traditional

K861274 - DOUBLE ANTIBODY CALCITONIN RIA KIT

K861274 is the FDA 510(k) clearance for DOUBLE ANTIBODY CALCITONIN RIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JKR) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K861274 · Diagnostic Products Corp. · Chemistry device
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Jun 1986
Decision
79d
Days
Class 2
Risk

K861274 is an FDA 510(k) clearance for the DOUBLE ANTIBODY CALCITONIN RIA KIT. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 25, 1986 after a review of 79 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K861274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date June 25, 1986
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K861274.
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
CALCITONIN RIA KIT
K854240 · Diagnostic Systems Laboratories, Inc. · Nov 1985
CALCITONIN RADIOIMMUNOASSAY KIT
K842907 · Nichols Institute Diagnostics · Sep 1984
CALCITONIN RIA TEST KIT, DLS 1200
K821675 · Diagnostic Systems Laboratories, Inc. · Jun 1982