Cleared Traditional

K833989 - VENTREZYME THEOPHYLLINE IMMUNOASSAY

K833989 is the FDA 510(k) clearance for VENTREZYME THEOPHYLLINE IMMUNOASSAY by Vxr, Inc.. It is a Class 2 Immunology device (product code KLS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K833989 · Vxr, Inc. · Immunology device
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Jan 1984
Decision
73d
Days
Class 2
Risk

K833989 is an FDA 510(k) clearance for the VENTREZYME THEOPHYLLINE IMMUNOASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Vxr, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3880 - 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 Vxr, Inc. devices

Submission Details

510(k) Number K833989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1983
Decision Date January 30, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 - KLS Enzyme Immunoassay, Theophylline

All 56
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K833989.
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · Miles Laboratories, Inc. · Mar 1984
STRATUS THEOPHYLLINE ASSAY
K832965 · American Dade · Dec 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · Abbott Laboratories · Dec 1983
THEOPHYLLINE TEST PACK ACA
K831934 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983