Cleared Traditional

K972162 - ELECSYS CA 125 II

K972162 is an FDA 510(k) clearance for ELECSYS CA 125 II, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code LTK cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K972162 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
282d
Days
Class 2
Risk

K972162 is an FDA 510(k) clearance for the ELECSYS CA 125 II. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 18, 1998 after a review of 282 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K972162

510(k) Number K972162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date March 18, 1998
Days to Decision 282 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
178d slower than avg
Panel avg: 104d · This submission: 282d
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 K972162.
IMMULITE 2000 OM-MA MODEL L2KOP2
K983391 · Diagnostic Products Corp. · Oct 1998
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
AXSYM CA 125
K964020 · Abbott Laboratories · Nov 1997
IMX CA 125
K964185 · Abbott Diagnostics · Nov 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964098 · Bayer Corp. · Oct 1997