Cleared Traditional

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

K933712 is an FDA 510(k) clearance for EL-RF TEST SYSTEM: EL-RF-IGM KIT, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K933712

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 105d · This submission: 182d
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 110
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
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K924036 · J.S. Medical Assoc. · Dec 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992