Cleared Traditional

K111369 - THE HELENA V8 IMMUNODISPLACEMENT KIT

K111369 is an FDA 510(k) clearance for THE HELENA V8 IMMUNODISPLACEMENT KIT, manufactured by Helena Laboratories Uk, Ltd.. The device is a Class 2 Immunology device with product code CFF cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K111369 · Helena Laboratories Uk, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
407d
Days
Class 2
Risk

K111369 is an FDA 510(k) clearance for the THE HELENA V8 IMMUNODISPLACEMENT KIT. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Helena Laboratories Uk, Ltd. (Beaumont, US). The FDA issued a Cleared decision on June 26, 2012 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Helena Laboratories Uk, Ltd. devices

FDA 510(k) Submission Details - K111369

510(k) Number K111369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date June 26, 2012
Days to Decision 407 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 105d · This submission: 407d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFF Device Classification - Class 2, Special Controls

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Immunology devices follow this clearance model.

Regulatory Peers - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 26
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K111369.
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · Sebia · Dec 2016
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · Sebia · Jan 2015
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · Grifols USA, LLC · Aug 2012
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757 · Grifols · Oct 2011
CAPILLARYS IMMUNOTYPING, MODEL 2100
K082085 · Sebia · Apr 2009
MINICAP IMMUNOTYPING, MODEL: 2300
K082388 · Sebia · Apr 2009