Cleared Traditional

K253528 - Atellica IM CA 19-9 II

K253528 is an FDA 510(k) clearance for Atellica IM CA 19-9 II, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code NIG cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K253528 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
270d
Days
Class 2
Risk

K253528 is an FDA 510(k) clearance for the Atellica IM CA 19-9 II. Classified as System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (product code NIG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 10, 2026 after a review of 270 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K253528

510(k) Number K253528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2025
Decision Date August 10, 2026
Days to Decision 270 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
165d slower than avg
Panel avg: 105d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NIG Device Classification - Class 2, Special Controls

Product Code NIG System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition An In Vitro Diagnostic Test For The Quantitative Measurement Of The Ca 19-9 Tumor Associated Antigen In Human Serum Or Plasma. The Test Is Intended As An Aid In The Management Of Patients With Confirmed Pancreatic Cancer And Serial Monitoring Of Their Response To Therapy And Disease Progression. The Test Should Only Be Used In Patients With Serum And Plasma Ca 19-9 Values Above The Cut-off At The Time Of Diagnosis And In Conjunction With Other Clinical Methods.
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 - NIG System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer

All 9
Devices cleared under the same product code (NIG) and FDA review panel - the closest regulatory comparables to K253528.
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · Ortho-Clinical Diagnostics · Aug 2023
Lumipulse G CA19-9-N
K200997 · Fujirebio Diagnostics,Inc. · May 2020
Lumpipulse G CA19-9-N
K191973 · Fujirebio Dianostics, Inc. · Oct 2019
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
K100375 · Siemens Healthcare Diagnostics, Inc. · Apr 2011
VITROS CA 19-9
K052889 · Fujirebio Diagnostics,Inc. · Dec 2005
ARCHITECT CA 19-9XR ASSAY
K052000 · Fujirebio Diagnostics,Inc. · Oct 2005