Cleared Traditional

K924578 - PSA ANTIBODY KIT

K924578 is an FDA 510(k) clearance for PSA ANTIBODY KIT, manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Immunology device with product code DFD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K924578 · Ventana Medical Systems, Inc. · Immunology device
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Feb 1993
Decision
148d
Days
Class 2
Risk

K924578 is an FDA 510(k) clearance for the PSA ANTIBODY KIT. Classified as Kappa, Peroxidase, Antigen, Antiserum, Control (product code DFD), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K924578

510(k) Number K924578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1992
Decision Date February 05, 1993
Days to Decision 148 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 105d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFD Device Classification - Class 2, Special Controls

Product Code DFD Kappa, Peroxidase, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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.