Cleared Traditional

K871319 - TITAN GEL MULTI-SLOT LIPO-17 SYSTEM

K871319 is the FDA 510(k) clearance for TITAN GEL MULTI-SLOT LIPO-17 SYSTEM by Helena Laboratories. It is a Class 1 Chemistry device (product code JHO) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K871319 · Helena Laboratories · Chemistry device
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Apr 1987
Decision
19d
Days
Class 1
Risk

K871319 is an FDA 510(k) clearance for the TITAN GEL MULTI-SLOT LIPO-17 SYSTEM. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 22, 1987 after a review of 19 days - a notably fast clearance 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: 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 K871319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1987
Decision Date April 22, 1987
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 K871319.
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679 · Helena Laboratories · Sep 1994
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223 · Helena Laboratories · Jun 1989
REP LIPO KIT CAT. NO 3180
K881809 · Helena Laboratories · Jun 1988
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · Beckman Instruments, Inc. · Dec 1985
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
K833611 · Helena Laboratories · Mar 1984
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · Beckman Instruments, Inc. · Dec 1980