Cleared Traditional

K852391 - EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

K852391 is an FDA 510(k) clearance for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYM..., manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code CFH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K852391 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
118d
Days
Class 2
Risk

K852391 is an FDA 510(k) clearance for the EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE. Classified as Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (product code CFH), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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

FDA 510(k) Submission Details - K852391

510(k) Number K852391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date October 01, 1985
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFH Device Classification - Class 2, Special Controls

Product Code CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

All 11
Devices cleared under the same product code (CFH) and FDA review panel - the closest regulatory comparables to K852391.
IQ LDH
K894578 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
LACTATE DEHYDROGENASE (LDH-L)
K880630 · Tech-Co, Inc. · Mar 1988
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · Sterling Diagnostics, Inc. · Feb 1986
WAKO LDH CII TEST
K842452 · Wako Chemicals USA, Inc. · Aug 1984
LDH REAGENT SET
K812836 · Anco Medical Reagents & Assoc. · Oct 1981
HYCEL LDH-INT TEST
K782176 · Hycel, Inc. · Jan 1979