Cleared Traditional

K963048 - IMMAGE SYSTEM RHEUMATOID FACTOR (RF) RE...

K963048 is an FDA 510(k) clearance for IMMAGE SYSTEM RHEUMATOID FACTOR (RF) RE..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963048 · Beckman Instruments, Inc. · Immunology device
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Nov 1996
Decision
90d
Days
Class 2
Risk

K963048 is an FDA 510(k) clearance for the IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K963048

510(k) Number K963048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1996
Decision Date November 04, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
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 92
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K963048.
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788 · Beckman Instruments, Inc. · Jun 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729 · Hycor Biomedical, Inc. · Mar 1997
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · Teco Diagnostics · Nov 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · Hemagen Diagnostics, Inc. · Sep 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · Randox Laboratories, Ltd. · Jun 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996