Cleared Traditional

K933712 - EL-RF TEST SYSTEM: EL-RF-IGM KIT

K933712 is the FDA 510(k) clearance for EL-RF TEST SYSTEM: EL-RF-IGM KIT by Theratest Laboratories, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K933712 · Theratest Laboratories, Inc. · Immunology device
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Jan 1994
Decision
182d
Days
Class 2
Risk

K933712 is an FDA 510(k) clearance for the EL-RF TEST SYSTEM: EL-RF-IGM 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 January 28, 1994 after a review of 182 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 K933712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1993
Decision Date January 28, 1994
Days to Decision 182 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
78d slower than avg
Panel avg: 104d · This submission: 182d
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 79
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K933712.
IGM RF EIA
K942908 · Sigma Diagnostics, Inc. · Jan 1995
N LATEX RF
K942328 · Behring Diagnostics, Inc. · Oct 1994
IGM RHEUMATOID FACTOR
K942272 · Immco Diagnostics, Inc. · Sep 1994
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320 · Trinity Laboratories, Inc. · Dec 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992