Cleared Traditional

K983715 - THE IMMUNO 1 CA 125 II ASSAY FOR THE BA...

K983715 is the FDA 510(k) clearance for THE IMMUNO 1 CA 125 II ASSAY FOR THE BA... by Bayer Corp.. It is a Class 2 Immunology device (product code LTK) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K983715 · Bayer Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
May 1999
Decision
205d
Days
Class 2
Risk

K983715 is an FDA 510(k) clearance for the THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOST.... Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 205 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 Bayer Corp. devices

Submission Details

510(k) Number K983715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date May 14, 1999
Days to Decision 205 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
101d slower than avg
Panel avg: 104d · This submission: 205d
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 21
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K983715.
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · Tosoh Medics, Inc. · Dec 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · Bayer Corp. · Jul 2002
AIA-PACK CA 125
K990431 · Tosoh Medics, Inc. · Jun 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
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · Diagnostic Products Corp. · Sep 1998