Cleared Traditional

K023239 - AIA-PACK CA 19-9

K023239 is an FDA 510(k) clearance for AIA-PACK CA 19-9, manufactured by Tosoh Corp.. The device is a Class 2 Immunology device with product code NIG cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K023239 · Tosoh Corp. · Immunology device
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Dec 2002
Decision
87d
Days
Class 2
Risk

K023239 is an FDA 510(k) clearance for the AIA-PACK CA 19-9. Classified as System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer (product code NIG), Class II - Special Controls.

Submitted by Tosoh Corp. (Seymour, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tosoh Corp. devices

FDA 510(k) Submission Details - K023239

510(k) Number K023239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date December 23, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 105d · This submission: 87d
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 10
Devices cleared under the same product code (NIG) and FDA review panel - the closest regulatory comparables to K023239.
ARCHITECT CA 19-9XR ASSAY
K052000 · Fujirebio Diagnostics,Inc. · Oct 2005
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
K033038 · Beckman Coulter, Inc. · Dec 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · Bayer Healthcare, LLC · Jun 2003
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
K020566 · Fujirebio Diagnostics,Inc. · May 2002