Cleared Traditional

K831670 - ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO

K831670 is the FDA 510(k) clearance for ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO by Ortho Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JFH) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K831670 · Ortho Diagnostic Systems, Inc. · Chemistry device
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Aug 1983
Decision
93d
Days
Class 2
Risk

K831670 is an FDA 510(k) clearance for the ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K831670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 24, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
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 28
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K831670.
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
CORDIA PAP
K831105 · Cordis Corp. · May 1983
ABBOTT PAP-EIA
K812925 · Abbott Laboratories · Jan 1982
TANDEM PAP KIT - (PARTS I & II)
K811959 · Hybritech, Inc. · Sep 1981