Cleared Traditional

K953261 - CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM

K953261 is an FDA 510(k) clearance for CHROMALEX RHEUMATOID FACTOR LATEX TEST ..., manufactured by Shared Systems, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K953261 · Shared Systems, Inc. · Immunology device
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Aug 1995
Decision
34d
Days
Class 2
Risk

K953261 is an FDA 510(k) clearance for the CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 34 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 Shared Systems, Inc. devices

FDA 510(k) Submission Details - K953261

510(k) Number K953261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date August 15, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 105d · This submission: 34d
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 109
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K953261.
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · Hycor Biomedical, Inc. · Dec 1995
TEST, RHEUMATOID FACTOR
K955086 · Polymedco, Inc. · Dec 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · Theratest Laboratories, Inc. · Jul 1995
IGM RF EIA
K942908 · Sigma Diagnostics, Inc. · Jan 1995
N LATEX RF
K942328 · Behring Diagnostics, Inc. · Oct 1994