Cleared Traditional

K942908 - IGM RF EIA

K942908 is the FDA 510(k) clearance for IGM RF EIA by Sigma Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K942908 · Sigma Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
213d
Days
Class 2
Risk

K942908 is an FDA 510(k) clearance for the IGM RF EIA. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 213 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K942908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date January 20, 1995
Days to Decision 213 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
109d slower than avg
Panel avg: 104d · This submission: 213d
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 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K942908.
RF IGM ELISA TEST SYSTEM
K961277 · Zeus Scientific, Inc. · May 1996
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · Hycor Biomedical, Inc. · Dec 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 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