Cleared Traditional

HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED) (K021022) - FDA 510(k) Clearance

Also marketed or referenced as:
HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

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

K021022 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
46d
Days
Class 2
Risk

K021022 is an FDA 510(k) clearance for the HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED). Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K021022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date May 14, 2002
Days to Decision 46 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
67d faster than avg
Panel avg: 113d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.