Cleared Traditional

K831941 - LEAP RHEUMATOID FACTOR TEST KIT

K831941 is an FDA 510(k) clearance for LEAP RHEUMATOID FACTOR TEST KIT, manufactured by Cooper Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831941 · Cooper Diagnostics, Inc. · Immunology device
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Jul 1983
Decision
32d
Days
Class 2
Risk

K831941 is an FDA 510(k) clearance for the LEAP RHEUMATOID FACTOR TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Cooper Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 32 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.

FDA 510(k) Submission Details - K831941

510(k) Number K831941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1983
Decision Date July 18, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 105d · This submission: 32d
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 139
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K831941.
NABI RF-Q.S. TEST
K840005 · Intl. Diagnostic, Inc. · Feb 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · Diagnostic Products Corp. · Feb 1984
IMMUNO-RA
K834391 · Immunostics Co., Inc. · Feb 1984
SERO/TEX RED CELL RF TEST
K831597 · Texas Immunology, Inc. · Jun 1983
RA-CHECK
K831467 · Diagnostic Technology, Inc. · Jun 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · Emd Chemicals, Inc. · Apr 1983
K831941 · LEAP RHEUMATOID FACTOR TEST KIT
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