Cleared Traditional

K942272 - IGM RHEUMATOID FACTOR

K942272 is an FDA 510(k) clearance for IGM RHEUMATOID FACTOR, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K942272 · Immco Diagnostics, Inc. · Immunology device
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Sep 1994
Decision
139d
Days
Class 2
Risk

K942272 is an FDA 510(k) clearance for the IGM RHEUMATOID FACTOR. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 26, 1994 after a review of 139 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K942272

510(k) Number K942272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1994
Decision Date September 26, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 104d · This submission: 139d
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 103
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K942272.
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · Theratest Laboratories, Inc. · Jul 1995
IGM RF EIA
K942908 · Sigma Diagnostics, Inc. · Jan 1995
N LATEX RF
K942328 · Behring Diagnostics, Inc. · Oct 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · Theratest Laboratories, Inc. · Jan 1994
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320 · Trinity Laboratories, Inc. · Dec 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992