Cleared Traditional

K850373 - ABBOTT RF EIA DIAGNOSTIC KIT

K850373 is an FDA 510(k) clearance for ABBOTT RF EIA DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code DHR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850373 · Abbott Laboratories · Chemistry device
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Mar 1985
Decision
29d
Days
Class 2
Risk

K850373 is an FDA 510(k) clearance for the ABBOTT RF EIA DIAGNOSTIC KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5775 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K850373

510(k) Number K850373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1985
Decision Date March 01, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 94
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K850373.
RA 80 EIKEN
K854820 · Syn-Kit, Inc. · Jan 1986
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · Behring Diagnostics, Inc. · Jun 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296 · Behring Diagnostics, Inc. · Apr 1985
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896 · Diagnostic Products Corp. · Oct 1984
RF TEST KIT
K841454 · Difco Laboratories, Inc. · Apr 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · Diagnostic Products Corp. · Feb 1984