Cleared Traditional

K962201 - QUANTEX IGM

K962201 is the FDA 510(k) clearance for QUANTEX IGM by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K962201 · Instrumentation Laboratory CO · Immunology device
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Sep 1996
Decision
110d
Days
Class 2
Risk

K962201 is an FDA 510(k) clearance for the QUANTEX IGM. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 25, 1996 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K962201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1996
Decision Date September 25, 1996
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 104d · This submission: 110d
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 Immunology devices follow this clearance model.

Regulatory Peers - DFT Igm, Antigen, Antiserum, Control

All 15
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K962201.
IGM
K983132 · Abbott Laboratories · Nov 1998
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · Randox Laboratories, Ltd. · Apr 1996
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · Reagents Applications, Inc. · Aug 1989
WAKO(TM) IGM-HA DIRECT
K880828 · Wako Chemicals USA, Inc. · Mar 1988
IMMUNOGLOBULINS M
K873871 · Unipath , Ltd. · Oct 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987