Cleared Traditional

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (K011389) - FDA 510(k) Clearance

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

K011389 · Canterbury Health Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 2001
Decision
45d
Days
Class 2
Risk

K011389 is an FDA 510(k) clearance for the HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL). Classified as Control, Hemoglobin, Abnormal (product code JCM), Class II - Special Controls.

Submitted by Canterbury Health Laboratories (Christchurch, Canterbury, NZ). The FDA issued a Cleared decision on June 21, 2001 after a review of 45 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 Canterbury Health Laboratories devices

Submission Details

510(k) Number K011389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date June 21, 2001
Days to Decision 45 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
68d faster than avg
Panel avg: 113d · This submission: 45d
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 K011389.
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