Cleared Traditional

K823884 - PARAGON IMMUNOELECTROPHORESIS REAGENT

K823884 is an FDA 510(k) clearance for PARAGON IMMUNOELECTROPHORESIS REAGENT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CFF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K823884 · Beckman Instruments, Inc. · Chemistry device
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Mar 1983
Decision
70d
Days
Class 2
Risk

K823884 is an FDA 510(k) clearance for the PARAGON IMMUNOELECTROPHORESIS REAGENT. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K823884

510(k) Number K823884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date March 07, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFF Device Classification - Class 2, Special Controls

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Chemistry devices follow this clearance model.

Regulatory Peers - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 21
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K823884.
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · The Binding Site, Ltd. · Feb 1993
REP IMMUNOFIX
K923658 · Helena Laboratories · Nov 1992
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · Helena Laboratories · Jun 1989
CORNING PARAPROTEIN SCREENING
K790667 · Corning Medical & Scientific · Jul 1979