Cleared Traditional

K873386 - TITAN GEL LDH REP SYSTEM

K873386 is the FDA 510(k) clearance for TITAN GEL LDH REP SYSTEM by Helena Laboratories. It is a Class 2 Chemistry device (product code CFE) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K873386 · Helena Laboratories · Chemistry device

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Oct 1987

Decision

57d

Days

Class 2

Risk

K873386 is an FDA 510(k) clearance for the TITAN GEL LDH REP SYSTEM. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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	K873386 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 24, 1987
Decision Date	October 20, 1987
Days to Decision	57 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

31d faster than avg

Panel avg: 88d · This submission: 57d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1445

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 19

Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K873386.

TITAN GEL REP LDH-30 HV

K874142 · Helena Laboratories · Nov 1987

TITAN GEL REP LDH-6 HV

K874145 · Helena Laboratories · Nov 1987

TITAN GEL REP LDH-12 HV

K874143 · Helena Laboratories · Nov 1987

CK/LD BUFFER (CAT. NO. 5808)

K861750 · Helena Laboratories · May 1986

ISOENZYME TEST LD-1

K850210 · Sclavo, Inc. · Mar 1985

TITAN GEL ISO DOT LDH KIT

K842669 · Helena Laboratories · Nov 1984

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 K873386

Helena Laboratories

Beaumont, TX · US

ERIC PETERSEN

Regulatory profile

280 submissions 280 cleared

100% clearance rate · Active in Chemistry

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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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