Cleared Traditional

K855013 - QUANTIMETRIC PLUS SUPPORT PACK

K855013 is the FDA 510(k) clearance for QUANTIMETRIC PLUS SUPPORT PACK by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K855013 · Kallestad Laboratories, Inc. · Immunology device
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Feb 1986
Decision
72d
Days
Class 2
Risk

K855013 is an FDA 510(k) clearance for the QUANTIMETRIC PLUS SUPPORT PACK. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 K855013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date February 26, 1986
Days to Decision 72 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
32d faster than avg
Panel avg: 104d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K855013.
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · Beckman Instruments, Inc. · Jun 1990
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · Kallestad Diag, A Div. of Erbamont, Inc. · Jan 1988
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · Kallestad Laboratories, Inc. · Feb 1986
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · Kallestad Laboratories, Inc. · Oct 1985
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · Kallestad Laboratories, Inc. · Jul 1984