Cleared Traditional

K855034 - AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (FDA 510(k) Clearance)

Class I Pathology device.

K855034 · Bartels Immunodiagnostic Supplies, Inc. · Pathology device
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Mar 1986
Decision
84d
Days
Class 1
Risk

K855034 is an FDA 510(k) clearance for the AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT. Classified as Peroxidase Anti-peroxidase Immunohistochemical Stain (product code LIJ), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4400 - 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: 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K855034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date March 11, 1986
Days to Decision 84 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 77d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIJ Peroxidase Anti-peroxidase Immunohistochemical Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.