Cleared Traditional

K832087 - TITAN GEL GLYCO-HEME SYSTEM

K832087 is the FDA 510(k) clearance for TITAN GEL GLYCO-HEME SYSTEM by Helena Laboratories. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K832087 · Helena Laboratories · Hematology device
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Aug 1983
Decision
57d
Days
Class 2
Risk

K832087 is an FDA 510(k) clearance for the TITAN GEL GLYCO-HEME SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - the FDA hematology device 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 K832087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 24, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 113d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 Hematology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K832087.
AUTO AIC ANALYZER SYSTEM
K833772 · Helena Laboratories · Jan 1984
GLYCO-JE,E CPMTRP
K833356 · Helena Laboratories · Nov 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775 · Abbott Laboratories · Sep 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478 · Bio-Rad · Jun 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935 · Bio-Rad · Jun 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · Helena Laboratories · Feb 1983