Cleared Traditional

K831105 - CORDIA PAP

K831105 is an FDA 510(k) clearance for CORDIA PAP, manufactured by Cordis Corp.. The device is a Class 2 Immunology device with product code JFH cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K831105 · Cordis Corp. · Immunology device
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May 1983
Decision
41d
Days
Class 2
Risk

K831105 is an FDA 510(k) clearance for the CORDIA PAP. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 41 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 Cordis Corp. devices

FDA 510(k) Submission Details - K831105

510(k) Number K831105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1983
Decision Date May 16, 1983
Days to Decision 41 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
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFH Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K831105.
DSL PAP RIA -DSL#3100
K844679 · Diagnostic Systems Laboratories, Inc. · Apr 1985
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
K843230 · Ventrex Laboratories, Inc. · Sep 1984
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · Ortho Diagnostic Systems, Inc. · Aug 1983
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
K822298 · Nuclear Medical Laboratories, Inc. · Sep 1982
ABBOTT PAP-EIA
K812925 · Abbott Laboratories · Jan 1982
TANDEM PAP KIT - (PARTS I & II)
K811959 · Hybritech, Inc. · Sep 1981