Cleared Traditional

K932326 - PSA ANTIBODY KIT

K932326 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 DEH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K932326 · Ventana Medical Systems, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
100d
Days
Class 2
Risk

K932326 is an FDA 510(k) clearance for the PSA ANTIBODY KIT. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 100 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 - K932326

510(k) Number K932326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date August 06, 1993
Days to Decision 100 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 105d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

Product Code DEH Lambda, 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.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K932326.
DAKO MOUSE ANTI-HUMAN T-CELL
K924804 · Dako Corp. · Nov 1994
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
K924726 · Dako Corp. · Jun 1994
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
K932136 · Dako Corp. · Jun 1994
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · Dako Corp. · Aug 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · Beckman Instruments, Inc. · Jun 1990
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · Kallestad Diag, A Div. of Erbamont, Inc. · Jan 1988