Cleared Traditional

K920220 - HEALTHTEST RHEUMATOID FACTOR ASSAY

K920220 is an FDA 510(k) clearance for HEALTHTEST RHEUMATOID FACTOR ASSAY, manufactured by Akers Research Corp.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920220 · Akers Research Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
57d
Days
Class 2
Risk

K920220 is an FDA 510(k) clearance for the HEALTHTEST RHEUMATOID FACTOR ASSAY. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Akers Research Corp. (Thorofare, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Akers Research Corp. devices

FDA 510(k) Submission Details - K920220

510(k) Number K920220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date March 13, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 104d · This submission: 57d
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 100
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K920220.
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
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
V-TREND TARGET RF TEST
K904105 · Texas Immunology, Inc. · Oct 1990
RAPITEX(R) RF NEW
K903852 · Behring Diagnostics, Inc. · Aug 1990