Cleared Traditional

K000257 - IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

K000257 is an FDA 510(k) clearance for IMMULITE 2000 PAP, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code JFH cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K000257 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
27d
Days
Class 2
Risk

K000257 is an FDA 510(k) clearance for the IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6. 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 February 23, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1020 - the FDA immunology device 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K000257

510(k) Number K000257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date February 23, 2000
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 105d · This submission: 27d
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 Immunology 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 K000257.
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
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