Cleared Traditional

K833423 - VENTREZYME EIA CONTROLS-IMMUNOASSAY

K833423 is the FDA 510(k) clearance for VENTREZYME EIA CONTROLS-IMMUNOASSAY by Ventrex Laboratories, Inc.. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K833423 · Ventrex Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
66d
Days
Class 1
Risk

K833423 is an FDA 510(k) clearance for the VENTREZYME EIA CONTROLS-IMMUNOASSAY. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K833423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date December 08, 1983
Days to Decision 66 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
38d faster than avg
Panel avg: 104d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 468
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K833423.
ORTHO BI-LEVEL RECEPTOR CONTROL
K834064 · Ortho Diagnostic Systems, Inc. · Mar 1984
OMNI-FAL I & II
K833009 · American Monitor Corp. · Jan 1984
TITANGEL HIGH RESOLUTION CONTROL
K833639 · Helena Laboratories · Jan 1984
ELECTROPHORESIS CONTROLS-3 IN 1
K831263 · Corning Medical & Scientific · Jul 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · American Dade · Feb 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · Fisher Scientific Co., LLC · Jan 1983