Cleared Traditional

K955798 - IGG IMMUNOTURBIDIMETRIC & CALIBRATOR

K955798 is an FDA 510(k) clearance for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K955798 · 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

K955798 is an FDA 510(k) clearance for the IGG IMMUNOTURBIDIMETRIC & CALIBRATOR. Classified as Igg, Antigen, Antiserum, Control (product code DEW), 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 866.5510 - 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 - K955798

510(k) Number K955798 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.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DEW Igg, Antigen, Antiserum, Control

All 57
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K955798.
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · Beckman Instruments, Inc. · Feb 1997
QUANTEX IGG
K962202 · Instrumentation Laboratory CO · Sep 1996
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
K951635 · Beckman Instruments, Inc. · May 1995
BEHRING NEPHELOMETER II
K943997 · Behring Diagnostics, Inc. · Oct 1994
OT IGG SORBENT
K934324 · Organon Teknika Corp. · Apr 1994