Cleared Traditional

EXTENDSURE HBFASC CONTROL (K053031) - FDA 510(k) Clearance

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

K053031 · Cantebury Scientific , Ltd. · Hematology device
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Dec 2005
Decision
41d
Days
Class 2
Risk

K053031 is an FDA 510(k) clearance for the EXTENDSURE HBFASC CONTROL. Classified as Control, Hemoglobin, Abnormal (product code JCM), Class II - Special Controls.

Submitted by Cantebury Scientific , Ltd. (Christchurch, Canterbury, NZ). The FDA issued a Cleared decision on December 7, 2005 after a review of 41 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 Cantebury Scientific , Ltd. devices

Submission Details

510(k) Number K053031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date December 07, 2005
Days to Decision 41 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
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCM Control, Hemoglobin, Abnormal
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 - JCM Control, Hemoglobin, Abnormal

All 11
Devices cleared under the same product code (JCM) and FDA review panel - the closest regulatory comparables to K053031.
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · Roche Diagnostic Systems, Inc. · Feb 1999
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · Helena Laboratories · Oct 1994
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · Bio-Rad · Jun 1991
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787 · Helena Laboratories · Apr 1982