Cleared Traditional

K843230 - VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC

K843230 is the FDA 510(k) clearance for VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code JFH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843230 · Ventrex Laboratories, Inc. · Immunology device
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Sep 1984
Decision
18d
Days
Class 2
Risk

K843230 is an FDA 510(k) clearance for the VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1020 - 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 K843230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1984
Decision Date September 04, 1984
Days to Decision 18 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
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFH Acid Phosphatase (prostatic), Tartrate Inhibited
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 28
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K843230.
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · Diagnostic Products Corp. · Sep 1985
TANDEM E PAP
K851950 · Hybritech, Inc. · Jun 1985
DSL PAP RIA -DSL#3100
K844679 · Diagnostic Systems Laboratories, Inc. · Apr 1985
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · Ortho Diagnostic Systems, Inc. · Aug 1983
CORDIA PAP
K831105 · Cordis Corp. · May 1983
ABBOTT PAP-EIA
K812925 · Abbott Laboratories · Jan 1982