Cleared Traditional

K981297 - IMMULITE OM-MA

K981297 is the FDA 510(k) clearance for IMMULITE OM-MA by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code LTK) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K981297 · Diagnostic Products Corp. · Immunology device
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Sep 1998
Decision
163d
Days
Class 2
Risk

K981297 is an FDA 510(k) clearance for the IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5. 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 September 18, 1998 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K981297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date September 18, 1998
Days to Decision 163 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
59d slower than avg
Panel avg: 104d · This submission: 163d
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 K981297.
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 2000 OM-MA MODEL L2KOP2
K983391 · Diagnostic Products Corp. · Oct 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · Boehringer Mannheim Corp. · Mar 1998
ELECSYS CA 125 II
K972162 · Boehringer Mannheim Corp. · Mar 1998
AXSYM CA 125
K964020 · Abbott Laboratories · Nov 1997