Cleared Traditional

K962201 - QUANTEX IGM

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

K962201 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K962201

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
5d slower than avg
Panel avg: 105d · This submission: 110d
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 Immunology 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 K962201.
IGM
K983132 · Abbott Laboratories · Nov 1998
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · Randox Laboratories, Ltd. · Apr 1996
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453 · Isolab, Inc. · Apr 1990
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · Reagents Applications, Inc. · Aug 1989
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K884147 · Orion Diagnostica, Inc. · Oct 1988
WAKO(TM) IGM-HA DIRECT
K880828 · Wako Chemicals USA, Inc. · Mar 1988