Cleared Traditional

K983391 - IMMULITE 2000 OM-MA MODEL L2KOP2

K983391 is the FDA 510(k) clearance for IMMULITE 2000 OM-MA MODEL L2KOP2 by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code LTK) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K983391 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
20d
Days
Class 2
Risk

K983391 is an FDA 510(k) clearance for the IMMULITE 2000 OM-MA MODEL L2KOP2. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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

Submission Details

510(k) Number K983391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date October 15, 1998
Days to Decision 20 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
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)

All 19
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K983391.
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · Bayer Corp. · Jul 2002
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K983715 · Bayer Corp. · May 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
K983875 · Ortho-Clinical Diagnostics, Inc. · May 1999
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · Diagnostic Products Corp. · Sep 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · Boehringer Mannheim Corp. · Mar 1998
ELECSYS CA 125 II
K972162 · Boehringer Mannheim Corp. · Mar 1998