Cleared Traditional

K812925 - ABBOTT PAP-EIA

K812925 is an FDA 510(k) clearance for ABBOTT PAP-EIA, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K812925 · Abbott Laboratories · Chemistry device
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Jan 1982
Decision
92d
Days
Class 2
Risk

K812925 is an FDA 510(k) clearance for the ABBOTT PAP-EIA. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 19, 1982 after a review of 92 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K812925

510(k) Number K812925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date January 19, 1982
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFH Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K812925.
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · Ortho Diagnostic Systems, Inc. · Aug 1983
CORDIA PAP
K831105 · Cordis Corp. · May 1983
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
K822298 · Nuclear Medical Laboratories, Inc. · Sep 1982
TANDEM PAP KIT - (PARTS I & II)
K811959 · Hybritech, Inc. · Sep 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169 · Amersham Corp. · May 1981