Cleared Traditional

K811545 - KALLESTAD QUANTITOPE LOW LEVEL IGE REAG

K811545 is the FDA 510(k) clearance for KALLESTAD QUANTITOPE LOW LEVEL IGE REAG by Kallestad Laboratories, Inc.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811545 · Kallestad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
23d
Days
Class 2
Risk

K811545 is an FDA 510(k) clearance for the KALLESTAD QUANTITOPE LOW LEVEL IGE REAG. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K811545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1981
Decision Date June 24, 1981
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K811545.
VENTREX 125I ANTI-IGE ALLERGY ISOTOPE
K820896 · Ventrex Laboratories, Inc. · Apr 1982
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · Pharmacia, Inc. · Dec 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · Ventrex Laboratories, Inc. · Jul 1981
TAN DEM* - IGE KIT
K802913 · Hybritech, Inc. · May 1981
PHADEZYM IGE PRIST TEST
K810507 · Pharmacia, Inc. · Mar 1981
RIA KIT, QUANTITOPE IGE
K781904 · Kallestad Laboratories, Inc. · Feb 1979