Cleared Traditional

K812485 - DAKO PAP KIT K504 (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812485 · Dako Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
163d
Days
Class 2
Risk

K812485 is an FDA 510(k) clearance for the DAKO PAP KIT K504. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1982 after a review of 163 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5550 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako Corp. devices

Submission Details

510(k) Number K812485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date February 10, 1982
Days to Decision 163 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 77d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, 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 Pathology devices follow this clearance model.

Regulatory Peers - DFH Kappa, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K812485.
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · Diazyme Laboratories, Inc. · Dec 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · The Binding Site Group , Ltd. · May 2025
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · Sebia · Feb 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
K231290 · The Binding Site, Ltd. · Jan 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022