Cleared Traditional

K871498 - TITAN GEL IMMUNOFIX CONTROLS

K871498 is the FDA 510(k) clearance for TITAN GEL IMMUNOFIX CONTROLS by Helena Laboratories. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K871498 · Helena Laboratories · Immunology device
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Apr 1987
Decision
13d
Days
Class 2
Risk

K871498 is an FDA 510(k) clearance for the TITAN GEL IMMUNOFIX CONTROLS. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 29, 1987 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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: 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 Helena Laboratories devices

Submission Details

510(k) Number K871498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1987
Decision Date April 29, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 104d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K871498.
WAKO(TM) IGM-HA DIRECT
K880828 · Wako Chemicals USA, Inc. · Mar 1988
IMMUNOGLOBULINS M
K873871 · Unipath , Ltd. · Oct 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
TINA-QUANT(R) IGM
K862762 · Boehringer Mannheim Corp. · Sep 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984