Cleared Traditional

K855012 - QUANTIMETRIC PLUS C4 REAGENT KIT

K855012 is the FDA 510(k) clearance for QUANTIMETRIC PLUS C4 REAGENT KIT by Kallestad Laboratories, Inc.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K855012 · Kallestad Laboratories, Inc. · Immunology device
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Feb 1986
Decision
72d
Days
Class 2
Risk

K855012 is an FDA 510(k) clearance for the QUANTIMETRIC PLUS C4 REAGENT KIT. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), 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 866.5240 - 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 K855012 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 DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K855012.
QM300 C4 ANTIBODY PACK
K872599 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
PRECIMAT(R) C4
K871023 · Boehringer Mannheim Corp. · May 1987
TINA-QUANT(R) (A) C4
K870931 · Boehringer Mannheim Corp. · Mar 1987
C4 ANTIGEN ANTIBODY CONTROL
K834605 · Technicon Instruments Corp. · Jan 1984
RABBIT ANTISERUM TO HUMAN C4
K831906 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981