Cleared Special

K200997 - Lumipulse G CA19-9-N

K200997 is an FDA 510(k) clearance for Lumipulse G CA19-9-N, manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Immunology device with product code NIG cleared through the Special 510(k) pathway after a 28-day FDA review.

K200997 · Fujirebio Diagnostics,Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
28d
Days
Class 2
Risk

K200997 is an FDA 510(k) clearance for the Lumipulse G CA19-9-N. Classified as System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (product code NIG), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 14, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200997

510(k) Number K200997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2020
Decision Date May 14, 2020
Days to Decision 28 days
Submission Type Special
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
77d faster than avg
Panel avg: 105d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 11
Devices cleared under the same product code (NIG) and FDA review panel - the closest regulatory comparables to K200997.
Atellica IM CA 19-9 II
K253528 · Siemens Healthcare Diagnostics, Inc. · Aug 2026
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · Ortho-Clinical Diagnostics · Aug 2023
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
K200997 · Lumipulse G CA19-9-N
Download PDF FDA Summary Fujirebio Diagnostics…