Cleared Traditional

K945522 - I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS

K945522 is an FDA 510(k) clearance for I.D.-ZONE IMMUNOFIXATION ELECTROPHORESI..., manufactured by Beckman-Diagnostic Systems Group. The device is a Class 2 Immunology device with product code DFT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K945522 · Beckman-Diagnostic Systems Group · Immunology device
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Dec 1994
Decision
32d
Days
Class 2
Risk

K945522 is an FDA 510(k) clearance for the I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 32 days - a notably fast clearance cycle.

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: 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 Beckman-Diagnostic Systems Group devices

FDA 510(k) Submission Details - K945522

510(k) Number K945522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date December 12, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 105d · This submission: 32d
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 26
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K945522.
IGM
K983132 · Abbott Laboratories · Nov 1998
QUANTEX IGM
K962201 · Instrumentation Laboratory CO · Sep 1996
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