Cleared Traditional

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

K033038 · Beckman Coulter, Inc. · Immunology

Dec 2003

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K033038 is an FDA 510(k) clearance for the GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688, a System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (Class II — Special Controls, product code NIG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 29, 2003, 91 days after receiving the submission on September 29, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K033038 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	December 29, 2003
Days to Decision	91 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.