Cleared Traditional

K833639 - TITANGEL HIGH RESOLUTION CONTROL

K833639 is the FDA 510(k) clearance for TITANGEL HIGH RESOLUTION CONTROL by Helena Laboratories. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K833639 · Helena Laboratories · Chemistry device

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Jan 1984

Decision

79d

Days

Class 1

Risk

K833639 is an FDA 510(k) clearance for the TITANGEL HIGH RESOLUTION CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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

Submission Details

510(k) Number	K833639 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 1983
Decision Date	January 04, 1984
Days to Decision	79 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

9d faster than avg

Panel avg: 88d · This submission: 79d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JJY Multi-analyte Controls, All Kinds (assayed)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1660

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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463

Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K833639.

NORMAL CLINICAL CHEM. CONTROL SERUM-

K840457 · Otisville Biotech, Inc. · Apr 1984

ORTHO BI-LEVEL RECEPTOR CONTROL

K834064 · Ortho Diagnostic Systems, Inc. · Mar 1984

OMNI-FAL I & II

K833009 · American Monitor Corp. · Jan 1984

VENTREZYME EIA CONTROLS-IMMUNOASSAY

K833423 · Ventrex Laboratories, Inc. · Dec 1983

ELECTROPHORESIS CONTROLS-3 IN 1

K831263 · Corning Medical & Scientific · Jul 1983

IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS

K823352 · American Dade · Feb 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833639

Helena Laboratories

Mchenry, IL · US

Regulatory profile

280 submissions 280 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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