Cleared Traditional

K790046 - G-HB QUIK COLUMN CONTROL

K790046 is the FDA 510(k) clearance for G-HB QUIK COLUMN CONTROL by Helena Laboratories. It is a Class 2 Hematology device (product code LCP) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K790046 · Helena Laboratories · Hematology device
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Jan 1979
Decision
21d
Days
Class 2
Risk

K790046 is an FDA 510(k) clearance for the G-HB QUIK COLUMN CONTROL. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 21 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 K790046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1979
Decision Date January 26, 1979
Days to Decision 21 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
92d faster than avg
Panel avg: 113d · This submission: 21d
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 K790046.
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT
K791103 · Leeco Diagnostics, Inc. · Jun 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
K791135 · Helena Laboratories · Jun 1979
QUIK COLUMN METHODOLOGY
K790583 · Helena Laboratories · Apr 1979
COLUMN TEST, HEMOGLOBIN A
K781948 · Bio-Rad · Dec 1978
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
K780573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
HEMOGLOBIN, TESTING SYSTEM
K781851 · Isolab, Inc. · Nov 1978