Cleared Traditional

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) (K962836) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962836 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
52d
Days
Class 2
Risk

K962836 is an FDA 510(k) clearance for the HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 52 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 Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K962836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date September 12, 1996
Days to Decision 52 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
52d faster than avg
Panel avg: 104d · This submission: 52d
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 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K962836.
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · Kamiya Biomedical Company · May 2020
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
EliA RF IgM Immunoassay
K182747 · Phadia AB · Dec 2018
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · Roche Diagnostics Corp. · Sep 2003
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003