Cleared Traditional

K100375 - DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (FDA 510(k) Clearance)

K100375 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Apr 2011
Decision
418d
Days
Class 2
Risk

K100375 is an FDA 510(k) clearance for the DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604. This device is classified as a System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (Class II - Special Controls, product code NIG).

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2011, 418 days after receiving the submission on February 12, 2010.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010. 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..

Submission Details

510(k) Number K100375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date April 06, 2011
Days to Decision 418 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code NIG — System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Device Class Class II - 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.