Cleared Traditional

K812077 - HELENA SICKLE-THAL QUIK COLUMN METHOD

K812077 is the FDA 510(k) clearance for HELENA SICKLE-THAL QUIK COLUMN METHOD by Helena Laboratories. It is a Class 2 Hematology device (product code JPD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K812077 · Helena Laboratories · Hematology device
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Aug 1981
Decision
27d
Days
Class 2
Risk

K812077 is an FDA 510(k) clearance for the HELENA SICKLE-THAL QUIK COLUMN METHOD. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7400 - 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 K812077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 18, 1981
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPD Hemoglobin A2 Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7400
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 - JPD Hemoglobin A2 Quantitation

All 11
Devices cleared under the same product code (JPD) and FDA review panel - the closest regulatory comparables to K812077.
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · Bio-Rad · Jan 1990
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · Bio-Rad · Feb 1988
BETA THALQUIK COLUMN #5341
K823870 · Helena Laboratories · Feb 1983
HELENA HBA2 QUIK COLUMN METHOD
K803108 · Helena Laboratories · Jan 1981
HEMOHLOBIN A2 CONTROL-LYOPHILIZED
K801410 · Isolab, Inc. · Jul 1980