Cleared Traditional

THERATEST EL-RFSCR (K962050) - FDA 510(k) Clearance

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

K962050 · Theratest Laboratories, Inc. · Immunology device
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Dec 1996
Decision
202d
Days
Class 2
Risk

K962050 is an FDA 510(k) clearance for the THERATEST EL-RFSCR. 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 December 16, 1996 after a review of 202 days - an extended review 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: 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 Theratest Laboratories, Inc. devices

Submission Details

510(k) Number K962050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date December 16, 1996
Days to Decision 202 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
98d slower than avg
Panel avg: 104d · This submission: 202d
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 K962050.
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QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
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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