Cleared Traditional

K833855 - TITAN GEL SILVER STAIN SYSTEM

K833855 is an FDA 510(k) clearance for TITAN GEL SILVER STAIN SYSTEM, manufactured by Helena Laboratories. The device is a Class 1 Pathology device with product code CEF cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K833855 · Helena Laboratories · Pathology device
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Feb 1984
Decision
112d
Days
Class 1
Risk

K833855 is an FDA 510(k) clearance for the TITAN GEL SILVER STAIN SYSTEM. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1630 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K833855

510(k) Number K833855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date February 27, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 77d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

CEF Device Classification - Class 1, General Controls

Product Code CEF Electrophoretic, Protein Fractionation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1630
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 - CEF Electrophoretic, Protein Fractionation

All 27
Devices cleared under the same product code (CEF) and FDA review panel - the closest regulatory comparables to K833855.
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211 · Helena Laboratories · Jun 1989
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
K870958 · Helena Laboratories · Apr 1987
CORNING HIGH RESOLUTION PROTEIN ELECTRO
K843397 · Corning Medical & Scientific · Sep 1984
PARAGON SERUM PROTEIN ELECTROPHORESIS
K802592 · Beckman Instruments, Inc. · Nov 1980
ECA BUFFER, PH 816
K781116 · Electrophoresis Corp. of America · Aug 1978
ECA PREP
K781117 · Electrophoresis Corp. of America · Aug 1978