Cleared Traditional

K855014 - QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

K855014 is the FDA 510(k) clearance for QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code JIX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K855014 · Kallestad Laboratories, Inc. · Immunology device
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Mar 1986
Decision
88d
Days
Class 2
Risk

K855014 is an FDA 510(k) clearance for the QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K855014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date March 14, 1986
Days to Decision 88 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 104d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K855014.
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K855199 · American Dade · Feb 1986
DMA CALIBRATORS
K854092 · Data Medical Associates, Inc. · Oct 1985
CORNING CERTAIN -ISE
K851939 · Corning Medical & Scientific · Jun 1985