Cleared Traditional

SPECIALTY ASSAYED CONTROL-2 (K100103) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 39
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
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · Helena Laboratories · Nov 1994
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · Baxter Healthcare Corp · Jun 1991