Cleared Traditional

K923578 - LIQUICHEK RHEUMATOID FACTOR CONTROL

K923578 is the FDA 510(k) clearance for LIQUICHEK RHEUMATOID FACTOR CONTROL by Bio-Rad. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K923578 · Bio-Rad · Immunology device
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Oct 1992
Decision
78d
Days
Class 2
Risk

K923578 is an FDA 510(k) clearance for the LIQUICHEK RHEUMATOID FACTOR CONTROL. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on October 6, 1992 after a review of 78 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 Bio-Rad devices

Submission Details

510(k) Number K923578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date October 06, 1992
Days to Decision 78 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
26d faster than avg
Panel avg: 104d · This submission: 78d
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 K923578.
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
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
RAPITEX(R) RF NEW
K903852 · Behring Diagnostics, Inc. · Aug 1990