Cleared Traditional

K871352 - PENTAVALENT ANTISERUM TO HUMAN IMMUNOGL...

K871352 is the FDA 510(k) clearance for PENTAVALENT ANTISERUM TO HUMAN IMMUNOGL... by Helena Laboratories. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K871352 · Helena Laboratories · Immunology device
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Apr 1987
Decision
16d
Days
Class 2
Risk

K871352 is an FDA 510(k) clearance for the PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 22, 1987 after a review of 16 days - a notably fast clearance cycle.

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: 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 K871352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date April 22, 1987
Days to Decision 16 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
88d faster than avg
Panel avg: 104d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
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 - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K871352.
IMMUNOGLOBULINS G
K873870 · Unipath , Ltd. · Oct 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · Abbott Laboratories · Aug 1987
QM300 IGG ANTIBODY PACK
K871340 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1987
TINA-QUANT(R) IGG
K862764 · Boehringer Mannheim Corp. · Sep 1986
DAKO ITA SYSTEM
K861059 · Dako Corp. · Aug 1986
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · Coulter Electronics, Inc. · Jul 1985