Cleared Traditional

EL-RF/3 (IGM-IGG-IGA) KIT (K941398) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941398 · Theratest Laboratories, Inc. · Immunology device
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Jul 1995
Decision
493d
Days
Class 2
Risk

K941398 is an FDA 510(k) clearance for the EL-RF/3 (IGM-IGG-IGA) KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on July 28, 1995 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Theratest Laboratories, Inc. devices

Submission Details

510(k) Number K941398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1994
Decision Date July 28, 1995
Days to Decision 493 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
389d slower than avg
Panel avg: 104d · This submission: 493d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K941398.
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
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QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
EliA RF IgM Immunoassay
K182747 · Phadia AB · Dec 2018
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · Bio-Rad · Apr 1999