Cleared Traditional

K844968 - EPICHROME PAP

K844968 is the FDA 510(k) clearance for EPICHROME PAP by Cetus Corp.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K844968 · Cetus Corp. · Chemistry device
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Feb 1985
Decision
45d
Days
Class 2
Risk

K844968 is an FDA 510(k) clearance for the EPICHROME PAP. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Cetus Corp. (Emeryville, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - the FDA in vitro diagnostics and chemistry 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 Cetus Corp. devices

Submission Details

510(k) Number K844968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1984
Decision Date February 07, 1985
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - JFH Acid Phosphatase (prostatic), Tartrate Inhibited

All 29
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K844968.
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · Diagnostic Products Corp. · Sep 1985
TANDEM E PAP
K851950 · Hybritech, Inc. · Jun 1985
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
CORDIA PAP
K831105 · Cordis Corp. · May 1983