(53 days)
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No
The summary describes a standard immunoassay for measuring a tumor marker. There is no mention of AI, ML, or any computational analysis beyond basic quantitative measurement and statistical comparison to a predicate device.
No
The device is an immunoassay for measuring a tumor-associated antigen (CA 19-9) to aid in the management and monitoring of pancreatic cancer. It is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas." It further clarifies that "CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined," indicating its role as an aid in diagnosis and monitoring of disease status.
No
The device description clearly outlines a physical immunoassay process involving reagents, paramagnetic particles, and incubation steps, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum". The term "in vitro" is a key indicator of an IVD.
- Sample Type: The assay is performed on "human serum", which is a biological sample taken from the body.
- Purpose: The assay is used to "aid in the management of patients diagnosed with cancers of the exocrine pancreas" and for "monitoring of disease status". These are diagnostic and monitoring purposes performed outside of the body.
- Device Description: The description details a laboratory-based immunoassay process involving reagents and a system to measure a substance in a biological sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur System. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined. This assay is not intended for use on any other system.
Product codes
NIG, JIT
Device Description
The ADVIA Centaur CA 19-9 assay is a fully automated, two-step sandwich immunoassay using direct, chemiluminescent technology. The method utilizes a single monoclonal antibody (Mab), 116-NS-19-9, for both the Solid Phase and the Lite Reagent. The Mab is both covalently coupled to paramagnetic particles in the Solid Phase as well as labeled with acridinium ester in the Lite Reagent.
The sample and Solid Phase are first incubated at 37℃ for 7.5 minutes. This step is followed by a wash step to remove excess unbound antigen. The Lite Reagent is then reacted with the Solid Phase that is bound to CA 19-9 antigen for an additional 20-minute incubation. This two-step protocol eliminates any high-dose hook effect in this assay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Concordance:
Monitoring of Pancreatic Cancer Patients for Changes in Disease Status: Correspondence of Serial CA 19-9 Changes as Measured by the ADVIA Centaur CA 19-9 Assay (Test Device) and Clinical Status (Per-Visit Analysis).
Sample size: 131 patients (Progression = 57, No Progression = 74)
Concordance = (39+47)/ 131 = 65.7% (95% CI of 54.9% to 76.3%)
Predictive Value (No Progression) = 47/74 = 63.5% (95% CI of 52.9% to 77.4%)
Predictive Value (Progression) = 39/57 = 68.4% (95% CI of 56.6% to 80.1%)
Comparison of ADVIA Centaur CA 19-9 Assay to Fujirebio Diagnostics CA 19-9 RIA:
Sample size: 360 samples
Relationship of ADVIA Centaur CA 19-9 to Fujirebio RIA: ADVIA Centaur CA 19-9 = 0.97 (Fujirebio RIA) + 0.13 Units/mL
Correlation coefficient (r) = 0.88
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: Within-run 4.3 – 11.3 %CV from 7.2 – 386.7 Units/mL, Total 5.5 – 14.5 %CV from 7.2 – 386.7 Units/mL
Hook Effect: No high dose effect up to 5,800,000 Units/mL
Analytical Sensitivity: 1.2 Units/mL
Concordance = 65.7% (95% CI of 54.9% to 76.3%)
Predictive Value (No Progression) = 63.5% (95% CI of 52.9% to 77.4%)
Predictive Value (Progression) = 68.4% (95% CI of 56.6% to 80.1%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
K 031393
JUN 2 4 2003
Section 4 Premarket Notification – 510(k)
Bayer HealthCare Diagnostics Division ADVIA Centaur® CA 19-9 Assay
Summary of Safety and Effectiveness
1
Bayer HealthCare, Diagnostics Division ADVIA Centaur CA 19-9 Assay
Summary of Safety and Effectiveness
This Summary of Safety and Effectiveness has been prepared in accordance with the requirements of 21 CFR 807.92, to provide sufficient information to understand the basis for a determination of substantial equivalence.
1. Submitter Information Kenneth T. Edds, Ph.D. Contact Person: Baver HealthCare Address: Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591 Phone: (914) 524 2446 Fax: (914) 524 2500 e-mail: ken.edds.b@bayer.com Date Summary Prepared: April 25, 2003 2. Device Information Propriety Name: ADVIA Centaur® CA 19-9 Assav Common Name: Immunological test for CA 19-9 Antigen (1116NS19-9 Antibody Defined Antigen) Classification Name: Tumor Associated Antigen Immunological Test System: Calibrator Class: = CFR: 21 CFR 866.6010; 21 CFR 862.1150 Product Code: NIG, JIT
3. Predicate Device Information
| Name: | Fujirebio Diagnostics CA 19-9 RIA |
|---|---|
| Manufacturer: | |
| Manufactured by: | Fujirebio Diagnostics, Inc. |
| 201 Great Valley Parkway | |
| Malvern, PA 19355 | |
| 510(k) Number: | K020566 |
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4. Device Description
The ADVIA Centaur CA 19-9 assay is a fully automated, two-step sandwich immunoassay using direct, chemiluminescent technology. The method utilizes a single monoclonal antibody (Mab), 116-NS-19-9, for both the Solid Phase and the Lite Reagent. The Mab is both covalently coupled to paramagnetic particles in the Solid Phase as well as labeled with acridinium ester in the Lite Reagent.
The sample and Solid Phase are first incubated at 37℃ for 7.5 minutes. This step is followed by a wash step to remove excess unbound antigen. The Lite Reagent is then reacted with the Solid Phase that is bound to CA 19-9 antigen for an additional 20-minute incubation. This two-step protocol eliminates any high-dose hook effect in this assay.
5. Statement of Intended Use
The ADVIA Centaur® CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur System. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined. This assay is not intended for use on any other system.
6. Substantial Equivalence
The ADVIA Centaur CA 19-9 Assay is substantially equivalent to the Fujirebio Diagnostics CA 19-9 RIA predicate device cleared under K020566. Both products are based on the use of the same monoclonal antibody (Mab), 1116NS19-9, which is intended for use in the quantitative determination of the CA 19-9 tumorassociated antigen.
(a) Technological Characteristics
The following table compares the technology features of the ADVIA Centaur CA 19-9 Assay with the Fujirebio Diagnostics CA 19-9 RIA predicate device:
| Feature | ADVIA Centaur® CA19-9
Immunoassay | Fujirebio Diagnostics CA 19-9
RIA (Predicate Device) |
|--------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of CA
19-9 tumor-associated antigen | Quantitative determination of CA
19-9 tumor-associated antigen |
| Indication for Use | An aid in the management of
patients diagnosed with cancers
of the exocrine pancreas | An aid in the management of
patients diagnosed with cancers
of the exocrine pancreas |
| Assay Principle | Chemiluminescence
immunoassay | Radioimmunoassay |
| Sample Type | Human serum | Human serum or plasma |
| Sample Volume | 75 µL | 100 µL |
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| Feature | ADVIA Centaur® CA19-9
Immunoassay | Fujirebio Diagnostics CA 19-9
RIA (Predicate Device) |
|-----------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Calibrator | CA 19-9 Calibrator set (2 levels) | CA 19-9 Standard set (6 levels
including 0) |
| Controls | Tumor Marker Plus 1, 2 Control
set | Defibrinated human plasma
containing 2 levels of CA 19-9 |
| Instrument | ADVIA Centaur System, a fully
automated, random-access
immunoassay analyzer | Manual method or semi-
automated with commercially
available rinsing/aspiration
systems |
| Measuring Range | 1.2 - 700 Units/mL | 0.9 - 240 Units/mL |
(b) Performance Characteristics
The following table compares the performance characteristics of the ADVIA Centaur CA 19-9 assay with the Fujirebio Diagnostics CA 19-9 RIA predicate device:
| Feature | Bayer ADVIA Centaur® CA 19-9
Immunoassay | Fujirebio Diagnostics CA 19-9
RIA (Predicate Device) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within-run 4.3 – 11.3 %CV from 7.2 – 386.7 Units/mL Total 5.5 – 14.5 %CV from 7.2 – 386.7 Units/mL | Values for duplicates should be within 15% of the mean (except for 0 standard0) |
| Hook Effect | No high dose effect up to 5,800,000 Units/mL | None up to 1,250,000 Units/mL |
| Analytical Sensitivity | 1.2 Units/mL | 0.9 Units/mL |
| Limitations/Warning/Precautions | This test has been evaluated with serum. No interference from hemoglobin up to 1200 mg/dL No interference from triglycerides up to 3500 mg/dL No interference from bilirubin up to 60 mg/dL No interference from human serum albumin up to 14 g/dL No interference from commonly used pharmaceutical drugs. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Results should always be assessed in conjunction with the patient's medical history, clinical evaluation and other diagnostic procedures. | This test has been evaluated with serum and plasma (using different anticoagulants). However, it is recommended that if the specimen type is changed during patient monitoring, the patient should be re-baselined to negate any potential biases due to specimen type. The assay should not be performed on clotted, icteric hemolyzed or lipemic samples. No interference from commonly used pharmaceutical drugs. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Results should always be assessed in conjunction with the patient's medical history, clinical evaluation and other diagnostic procedures. |
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(c) Clinical Concordance
The following two 2x2 tables compare the clinical concordance of the ADVIA Centaur CA 19-9 Assay (test device) and the Fujirebio Diagnostics CA 19-9 RIA (predicate device) with a change in a patient's CA 19-9 value relative to disease progression.
Monitoring of Pancreatic Cancer Patients for Changes in Disease Status: Correspondence of Serial CA 19-9 Changes as Measured by the ADVIA Centaur CA 19-9 Assay (Test Device) and Clinical Status (Per-Visit Analysis).
| Change in CA 19-9 | Change in Disease State | ||
|---|---|---|---|
| Progression | No Progression | Total | |
| > 15% increase | 39 | 27 | 66 |
| ≤ 15% increase | 18 | 47 | 65 |
| Total | 57 | 74 | 131 |
Concordance = (39+47)/ 131 = 65.7% (95% CI of 54.9% to 76.3%) Predictive Value (No Progression) = 47/74 = 63.5% (95% CI of 52.9% to 77.4%) Predictive Value (Progression) = 39/57 = 68.4% (95% CI of 56.6% to 80.1%)
Monitoring of Pancreatic Cancer Patients for Changes in Disease Status: Correspondence of Serial CA 19-9 Changes as Measured by the Fujirebio Diagnostics CA 19-9 RIA (Predicate Device) and Clinical Status (Per-Visit Analysis),
| Change in CA 19-9 | Progression | No Progression | Total |
|---|---|---|---|
| > 20% increase | 37 | 19 | 57 |
| ✓ | |||
| ------------------------------------------ | ---------------------------------------------------------------- | ||
| ------------------------------------------ | ---------------------------------------------------------------- |
OR
| Division Sign-Off | JP Reves for S.Banton |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------ |
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| -- | ---------------------------------------------------------------------------------------- |
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K031393 |
|---|---|
| -------- | --------------------------------------------------------- |