Cleared Traditional

K981573 - UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

K981573 is an FDA 510(k) clearance for UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHA..., manufactured by United Biotech, Inc.. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K981573 · United Biotech, Inc. · Chemistry device
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Sep 1998
Decision
134d
Days
Class 2
Risk

K981573 is an FDA 510(k) clearance for the UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 134 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 United Biotech, Inc. devices

FDA 510(k) Submission Details - K981573

510(k) Number K981573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date September 15, 1998
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
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 34
Devices cleared under the same product code (JFH) and FDA review panel - the closest regulatory comparables to K981573.
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · Diagnostic Products Corp. · Feb 2000
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · Wano-Tech Corp. · Apr 1997
IMMULITE PAP
K931701 · Diagnostic Products Corp. · Jan 1994
IMX PAP
K925377 · Abbott Laboratories · Jan 1993
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO
K921745 · Hybritech, Inc. · Jul 1992
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937 · Diagnostic Products Corp. · Sep 1990