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)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100375 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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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 CALI.... 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. (Newark, US). The FDA issued a Cleared decision on April 6, 2011 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 104d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.