Cleared Traditional

K822123 - ISOPROPANOL HEMOGLOBIN STABILITY TEST

K822123 is the FDA 510(k) clearance for ISOPROPANOL HEMOGLOBIN STABILITY TEST by Helena Laboratories. It is a Class 2 Hematology device (product code GKA) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K822123 · Helena Laboratories · Hematology device
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Aug 1982
Decision
17d
Days
Class 2
Risk

K822123 is an FDA 510(k) clearance for the ISOPROPANOL HEMOGLOBIN STABILITY TEST. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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 K822123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date August 05, 1982
Days to Decision 17 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
96d faster than avg
Panel avg: 113d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKA Abnormal Hemoglobin Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 - GKA Abnormal Hemoglobin Quantitation

All 13
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K822123.
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · Bio-Rad · Jan 1993
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · Beckman Instruments, Inc. · May 1984
RESOLVE-HB
K840011 · Isolab, Inc. · Feb 1984
HELENA HEMOGLOBIN DETECT COLUMN SYS
K820573 · Helena Laboratories · Apr 1982
ORTHO SICKLE CELL CONTROLS
K811894 · Ortho Diagnostic Systems, Inc. · Jul 1981