Cleared Traditional

K100103 - SPECIALTY ASSAYED CONTROL-2

K100103 is an FDA 510(k) clearance for SPECIALTY ASSAYED CONTROL-2, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K100103 · Helena Laboratories · Hematology device
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Dec 2010
Decision
336d
Days
Class 2
Risk

K100103 is an FDA 510(k) clearance for the SPECIALTY ASSAYED CONTROL-2. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 15, 2010 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Helena Laboratories devices

FDA 510(k) Submission Details - K100103

510(k) Number K100103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2010
Decision Date December 15, 2010
Days to Decision 336 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
223d slower than avg
Panel avg: 113d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGC Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K100103.
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
STA - CONTROL LA 1+2
K061803 · Diagnostica Stago, Inc. · Jul 2006
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
K-ASSAY D-DIMER CONTROLS
K012422 · Kamiya Biomedical Co. · Aug 2001