Cleared Traditional

K021924 - MEDICA EASYQC HEMATOCRIT CONTROL

K021924 is an FDA 510(k) clearance for MEDICA EASYQC HEMATOCRIT CONTROL, manufactured by Bionostics, Inc.. The device is a Class 2 Hematology device with product code GLK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K021924 · Bionostics, Inc. · Hematology device
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Jun 2002
Decision
13d
Days
Class 2
Risk

K021924 is an FDA 510(k) clearance for the MEDICA EASYQC HEMATOCRIT CONTROL. Classified as Control, Hematocrit (product code GLK), Class II - Special Controls.

Submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on June 24, 2002 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Bionostics, Inc. devices

FDA 510(k) Submission Details - K021924

510(k) Number K021924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date June 24, 2002
Days to Decision 13 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 113d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLK Device Classification - Class 2, Special Controls

Product Code GLK Control, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - GLK Control, Hematocrit

Devices cleared under the same product code (GLK) and FDA review panel - the closest regulatory comparables to K021924.
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · Aalto Scientific, Ltd. · May 2002
HEMATACHEK
K964452 · Richmond Diagnostics, Inc. · Feb 1997
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · Ciba Corning Diagnostics Corp. · Jul 1996
MSI-HCT
K924926 · Medical Specialties, Inc. · Jan 1993
A.QC HCT LEVEL 1 AND 2
K893562 · Johnson & Johnson Professionals, Inc. · Jul 1989