Cleared Traditional

K931701 - IMMULITE PAP

K931701 is an FDA 510(k) clearance for IMMULITE PAP, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code JFH cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K931701 · Diagnostic Products Corp. · Chemistry device
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Jan 1994
Decision
296d
Days
Class 2
Risk

K931701 is an FDA 510(k) clearance for the IMMULITE PAP. Classified as Acid Phosphatase (prostatic), Tartrate Inhibited (product code JFH), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 296 days - an extended review 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: 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K931701

510(k) Number K931701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date January 27, 1994
Days to Decision 296 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 88d · This submission: 296d
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 K931701.
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · Diagnostic Products Corp. · Feb 2000
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
K981573 · United Biotech, Inc. · Sep 1998
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · Wano-Tech Corp. · Apr 1997
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