Cleared Traditional

SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR (K971788) - FDA 510(k) Clearance

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

K971788 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
20d
Days
Class 2
Risk

K971788 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIB.... 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 June 3, 1997 after a review of 20 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K971788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1997
Decision Date June 03, 1997
Days to Decision 20 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
84d faster than avg
Panel avg: 104d · This submission: 20d
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 36
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K971788.
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · Beckman Instruments, Inc. · Jun 1997
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc. · Jun 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · Boehringer Mannheim Corp. · Jun 1997
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 1995