Cleared Traditional

ELECSYS CA 125 II (K972162) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972162 · Boehringer Mannheim Corp. · Immunology device
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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

Submission Details

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.

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 12
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