Cleared Traditional

K833611 - TITAN GEL LIPOPROTEIN ELECTROPHORESIS

K833611 is the FDA 510(k) clearance for TITAN GEL LIPOPROTEIN ELECTROPHORESIS by Helena Laboratories. It is a Class 1 Chemistry device (product code JHO) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K833611 · Helena Laboratories · Chemistry device
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Mar 1984
Decision
154d
Days
Class 1
Risk

K833611 is an FDA 510(k) clearance for the TITAN GEL LIPOPROTEIN ELECTROPHORESIS. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on March 15, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K833611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1983
Decision Date March 15, 1984
Days to Decision 154 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
66d slower than avg
Panel avg: 88d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - JHO Electrophoretic Separation, Lipoproteins

All 19
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K833611.
REP LIPO KIT CAT. NO 3180
K881809 · Helena Laboratories · Jun 1988
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319 · Helena Laboratories · Apr 1987
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · Beckman Instruments, Inc. · Dec 1985
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · Beckman Instruments, Inc. · Dec 1980
CHOLESTEROL REAGENT SUBSTRATE SET
K781970 · Corning Medical & Scientific · Jan 1979
HDL CHOLESTEROL METHOD
K780256 · Helena Laboratories · Mar 1978