Cleared Traditional

K803016 - HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.

K803016 is the FDA 510(k) clearance for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. by Helena Laboratories. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K803016 · Helena Laboratories · Hematology device
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Dec 1980
Decision
32d
Days
Class 2
Risk

K803016 is an FDA 510(k) clearance for the HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 30, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 K803016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1980
Decision Date December 30, 1980
Days to Decision 32 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
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 18
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K803016.
HEMOGLOBIN REAGENT SET
K841057 · Medical Specialties, Inc. · Mar 1984
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · King Diagnostics, Inc. · Aug 1981
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980
HGB3 (1:251)
K802266 · R&D Systems, Inc. · Oct 1980
SYSING AND HEMOGLOBIN REAGENT
K780829 · Harleco · Jun 1978
BLANKING SOLUTION HGB
K771789 · J.T. Baker Chemical Co. · Oct 1977