Cleared Traditional

K830606 - QUIK-SEP IGM ISOLATION SYSTEM

K830606 is the FDA 510(k) clearance for QUIK-SEP IGM ISOLATION SYSTEM by Isolab, Inc.. It is a Class 2 Chemistry device (product code DFT) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K830606 · Isolab, Inc. · Chemistry device
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Mar 1983
Decision
27d
Days
Class 2
Risk

K830606 is an FDA 510(k) clearance for the QUIK-SEP IGM ISOLATION SYSTEM. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Isolab, Inc. (Walker, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5550 - 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 Isolab, Inc. devices

Submission Details

510(k) Number K830606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1983
Decision Date March 24, 1983
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, 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 Chemistry devices follow this clearance model.

Regulatory Peers - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K830606.
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
ACA IMMUNOGLOBIN M TEST PACK
K812632 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
AIM SYSTEM (FOR IGM)
K811124 · Icl Scientific · May 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · Icl Scientific · Jan 1981