Cleared Traditional

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (K061047) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061047 · Hemocue AB · Hematology device
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Jun 2006
Decision
55d
Days
Class 2
Risk

K061047 is an FDA 510(k) clearance for the HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on June 8, 2006 after a review of 55 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 Hemocue AB devices

Submission Details

510(k) Number K061047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2006
Decision Date June 08, 2006
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
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 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K061047.
HemoCue Hb 301 System
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K200909 · Ekf Diagnostic GmbH · Jun 2020
HemoCue Hb 801 System
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hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018