Cleared Traditional

K102552 - HEMOSIL LA POSITIVE CONTROL

K102552 is the FDA 510(k) clearance for HEMOSIL LA POSITIVE CONTROL by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K102552 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
210d
Days
Class 2
Risk

K102552 is an FDA 510(k) clearance for the HEMOSIL LA POSITIVE CONTROL. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on April 5, 2011 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K102552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date April 05, 2011
Days to Decision 210 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
97d slower than avg
Panel avg: 113d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
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.

Regulatory Peers - GGC Control, Plasma, Abnormal

All 21
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K102552.
SPECIALTY ASSAYED CONTROL-2
K100103 · Helena Laboratories · Dec 2010
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · Sigma Diagnostics, Inc. · Feb 2002
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · Sigma Diagnostics, Inc. · Mar 2001
LA POSITIVE CONTROL PLASMA
K961370 · Medical Diagnostic Technologies, Inc. · May 1996