Cleared Traditional

K972456 - RHEUMACOL RHEUMATOID FACTOR TEST

K972456 is an FDA 510(k) clearance for RHEUMACOL RHEUMATOID FACTOR TEST, manufactured by Immunostics Inc.,. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K972456 · Immunostics Inc., · Immunology device
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Nov 1997
Decision
147d
Days
Class 2
Risk

K972456 is an FDA 510(k) clearance for the RHEUMACOL RHEUMATOID FACTOR TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 147 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 Immunostics Inc., devices

FDA 510(k) Submission Details - K972456

510(k) Number K972456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date November 25, 1997
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 104d · This submission: 147d
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 96
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K972456.
COLOR-SLIDE RF
K981496 · Seradyn, Inc. · Jun 1998
DIAMEDIX IS-RF TEST SYSTEM
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RAPET RF
K974370 · Stanbio Laboratory · Feb 1998
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · Instrumentation Laboratory CO · Oct 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220 · Randox Laboratories, Ltd. · Sep 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · Beckman Instruments, Inc. · Jun 1997