Cleared Traditional

K955797 - IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR

K955797 is an FDA 510(k) clearance for IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Immunology device with product code DFT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K955797 · Randox Laboratories, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
105d
Days
Class 2
Risk

K955797 is an FDA 510(k) clearance for the IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on April 5, 1996 after a review of 105 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K955797

510(k) Number K955797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date April 05, 1996
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
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 K955797.
IGM
K983132 · Abbott Laboratories · Nov 1998
QUANTEX IGM
K962201 · Instrumentation Laboratory CO · Sep 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