Cleared Traditional

K830606 - QUIK-SEP IGM ISOLATION SYSTEM

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

K830606 · Isolab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K830606

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.

DFT Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K830606.
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
FIAX IGM TEST KIT
K831608 · Intl. Diagnostic Technology · Jun 1983
TIA-IGM REAGENT & CALIBRATOR SETS
K831103 · Worthington Diagnostic Systems · Apr 1983
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