Cleared Traditional

K964185 - IMX CA 125

K964185 is an FDA 510(k) clearance for IMX CA 125, manufactured by Abbott Diagnostics. The device is a Class 2 Immunology device with product code LTK cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K964185 · Abbott Diagnostics · Immunology device
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Nov 1997
Decision
379d
Days
Class 2
Risk

K964185 is an FDA 510(k) clearance for the IMX CA 125. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Abbott Diagnostics (Abbott Park, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Abbott Diagnostics devices

FDA 510(k) Submission Details - K964185

510(k) Number K964185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date November 04, 1997
Days to Decision 379 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
275d slower than avg
Panel avg: 104d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTK Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K964185.
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
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964098 · Bayer Corp. · Oct 1997