Cleared Traditional

K803281 - AUTOMATED ELECTROPHORESIS SYSTEM

K803281 is an FDA 510(k) clearance for AUTOMATED ELECTROPHORESIS SYSTEM, manufactured by Helena Laboratories. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K803281 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
18d
Days
Class 1
Risk

K803281 is an FDA 510(k) clearance for the AUTOMATED ELECTROPHORESIS SYSTEM. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2485 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K803281

510(k) Number K803281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1980
Decision Date January 16, 1981
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JJN Device Classification - Class 1, General Controls

Product Code JJN Apparatus, Electrophoresis, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJN Apparatus, Electrophoresis, For Clinical Use

All 23
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K803281.
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · Helena Laboratories · Jun 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · Helena Laboratories · Jun 1982
HI-PHORE HIGH RESOLUTION ELECTROPHORES
K821303 · Gelman Sciences, Inc. · May 1982
GENERAL PROCEDURE AGAROSE FILM
K802396 · Electrophoresis Corp. of America · Nov 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · Corning Medical & Scientific · Sep 1980
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · Gelman Sciences, Inc. · Jul 1980