Cleared Traditional

K961169 - RHEUMATOID FACTOR LATEX SLIDE TEST KIT

K961169 is an FDA 510(k) clearance for RHEUMATOID FACTOR LATEX SLIDE TEST KIT, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K961169 · Randox Laboratories, Ltd. · Immunology device
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Jun 1996
Decision
93d
Days
Class 2
Risk

K961169 is an FDA 510(k) clearance for the RHEUMATOID FACTOR LATEX SLIDE TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 26, 1996 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 - K961169

510(k) Number K961169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1996
Decision Date June 26, 1996
Days to Decision 93 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
12d faster than avg
Panel avg: 105d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K961169.
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
QUALITROL RF CONTROLS
K961545 · Consolidated Technologies, Inc. · Sep 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · Hemagen Diagnostics, Inc. · Sep 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996
RF IGM ELISA TEST SYSTEM
K961277 · Zeus Scientific, Inc. · May 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703 · Globe Management Support, Inc. · Apr 1996