Cleared Traditional

K972220 - RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT

K972220 is an FDA 510(k) clearance for RHEUMATOID FACTOR LATEX-ENHANCED IMMUNO..., 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 89-day FDA review.

K972220 · Randox Laboratories, Ltd. · Immunology device
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Sep 1997
Decision
89d
Days
Class 2
Risk

K972220 is an FDA 510(k) clearance for the RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on September 9, 1997 after a review of 89 days - a notably fast clearance cycle.

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: 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K972220

510(k) Number K972220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1997
Decision Date September 09, 1997
Days to Decision 89 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
16d faster than avg
Panel avg: 105d · This submission: 89d
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 K972220.
RAPET RF
K974370 · Stanbio Laboratory · Feb 1998
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · Immunostics Inc., · Nov 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · Instrumentation Laboratory CO · Oct 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · Beckman Instruments, Inc. · Jun 1997
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc. · Jun 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · Boehringer Mannheim Corp. · Jun 1997