(92 days)
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No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) assay designed for quantitative determination of a biomarker (CA 19-9) to aid in the management of pancreatic cancer patients. It does not provide therapy or treatment.
Yes.
The device is an immunoassay intended for the quantitative determination of specific reactive determinants in human serum or plasma to aid in the management of pancreatic cancer patients, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a system (ARCHITECT i System) to measure light units. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma". This involves testing biological samples (serum or plasma) in vitro (outside the body).
- Device Description: The description details a "two-step immunoassay" using "CMIA technology" to measure substances in human samples. This is a typical description of an in vitro diagnostic test.
- Intended User / Care Setting: The intended users are "Clinical and Hospitals laboratories," which are settings where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies describe testing "serum specimens" and "individual serum samples," further confirming the use of biological samples in vitro.
- Predicate Device: The mention of a "Predicate Device" (Fujirebio Diagnostics, Inc. CA 19-9 RIA) which is also an immunoassay for CA 19-9, strongly indicates that this device falls under the same regulatory category, which is IVD.
The core function of the device is to analyze components of human biological samples to provide information for medical purposes (aiding in the management of pancreatic cancer patients), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. 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. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.
Product codes (comma separated list FDA assigned to the subject device)
NIG, JIT, JJX
Device Description
The ARCHITECT CA 19-9xR assay is a two-step immunoassay for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and 1116-NS-19-9 coated paramagnetic microparticles are combined. 1116-NS-19-9 reactive determinants present in the sample bind to the 1116-NS-19-9 coated microparticles. After washing, 1116-NS-19-9 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of 1116-NS-19-9 reactive determinants in the sample and the RLUs detected by the ARCHITECT i System optics.
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
Pancreas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and Hospitals laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Reproducibility:
Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) protocol EP5-A. Samples were tested consisting of two panels of serum to which 1116-NS-19-9 reactive determinants were added (panel 3), and the ARCHITECT CA 19-9xR Controls, using two lots of reagents, in quadruplicate, two separate times per day, for 20 nonconsecutive days on two instruments. Each team lot used a single calibration curve throughout the study. The total precision %CV of the ARCHITECT CA 19-9xp assay was determined to be less than or equal to 10%.
Comparison Study
A total of 259 serum specimens were tested using the ARCHITECT CA 19-9xx assay and the Fujirebio Diagnostics, Inc. CA 19-9 RIA. Passing-Bablok linear regression analysis was performed on all specimens (2.0 - 9115.7 U/mL for the ARCHITECT CA 19-9xR assay and 1.17 - 10,782 U/mL for the Fujirebio Diagnostics, Inc. CA 19-9 RIA). Passing-Bablok linear regression analysis comparing the ARCHITECT CA 19-9xR assay to the Fujirebio Diagnostics, Inc. CA 19-9 RIA yielded a correlation coefficient of 0.96, a slope of 1.2 (99% confidence interval of 1.08, 1.37), and Y-axis intercept of -5.1 U/mL (99% confidence interval of -7.4, -3.4).
Reference Ranges:
Apparently Healthy Population:
360 serum specimens from apparently healthy individuals were tested. In this study, 94.4% of the specimens from apparently healthy subjects (n=360) had values of 37 U/mL or less.
Patient Groups:
978 individual serum samples from patients with various malignant and non-malignant diseases were tested.
Pancreatic Cancer Serial Specimens
This analysis is based on 74 patients. There were a total of 261 evaluable observations. The average number of observations per patient is 3.5. The average age of the subjects at time of diagnosis was 61.8 years (Exact 55% Cl: 59.5 years to 64.1 years) with a range of 17 to 85 years. Fifty-five percent (55% or 41/74) of the patients were men and forty-five percent (45% or 33/74) were women. Staging information was available from the charts for 70 of the 74 patients. The majority of the patients were stage IV (84.3%). 4.3% and 6.8% were stage 1 and 11 respectively.
Association between Change in Marker Value and Change in Disease State
A 2x2 table was constructed to show the association between a positive change in a patient's CA 19-9 value and progression of the disease from one observation to the next. A positive change is a value that is at least 2.5 times greater than the total %CV of the test. For the test assay this value is 14.0%.
Total Concordance: C = (16+98) / 187 = 114/187 = 61.0%
Positive Concordance: C+ = 16/33 = 48.5%
Negative Concordance: C- = 98/154 = 63.6%
Per Patient Analysis
Estimates of per-patient concordances can be obtained.
Statistic: C, Estimate: 68.92%, Lower Bound: 57.10%, Upper Bound: 79.17%
Statistic: C+, Estimate: 68.18%, Lower Bound: 45.13%, Upper Bound: 86.14%
Statistic: C, Estimate: 69.23%, Lower Bound: 54.90%, Upper Bound: 81.28%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
007 2 5 2005 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This Sammary with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: __ OS2دهده (
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Contact person: | Diana L. Wolaniuk, (610) 240-3917 |
| Summary preparation date: | October 25, 2005 |
| Name of Device | |
| Trade/Proprietary Name: | ARCHITECT® CA 19-9™XR Assay |
| Common/Usual Name: | CA 19-9 Assay |
| Classification Name: | System, Test, Carbohydrate Antigen (CA19-9), For Monitoring
And Management Of Pancreatic Cancer |
| Predicate Device | Fujirebio Diagnostics, Inc. CA 19-9 RIA |
Device Description
The ARCHITECT CA 19-9xR assay is a two-step immunoassay for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
In the first step, sample and 1116-NS-19-9 coated paramagnetic microparticles are combined. 1116-NS-19-9 reactive determinants present in the sample bind to the 1116-NS-19-9 coated microparticles. After washing, 1116-NS-19-9 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of 1116-NS-19-9 reactive determinants in the sample and the RLUs detected by the ARCHITECT i System optics.
For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.
1
Intended Use
Reagent Kit
The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay The ARCHITECT OF 15 SXF doody to a Shorts -19-9 reactive determinants in human (CMIA) for the qualificatio dotorminative i System. The ARCHITECT CA 19-9xR assay is to be serum of plasma on the Arcorn EST pancreatic cancer patients in conjunction with other clinical methods.
Patients known to be genotypically negative for the Lewis blood group antigen will be unable Fallents known to be genotyploany nogation for seence of malignant tissue. Phenotyping for to produce the OA 10 0 anligen may be insufficient to detect true Lewis antigen negative the presence of the Eowlo antigon may of the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.
Calibrator Kit
The ARCHITECT CA 19-9xp Calibrators are for the calibration of the ARCHITECT i System The AROMITED OF OF TO OX Calleration of 1116-NS-19-9 reactive determinants in when used for the qualitian. Refer to the ARCHITECT CA 19-9xe reagent package insert for additional information.
Control Kit
The ARCHITECT CA 19-9xR Controls are for the estimation of test precision and the The ARCHITEOT OF 15 ox 30 ox Sentralia and the ARCHITECT i System (reagents, delection of Systemation and for the quantitative measurement of 111-NS-19-9 canbrutors, and instruments in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information.
Statement of Substantial Equivalence
The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human (Onlin) for the quantitiatio assessment i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
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. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.
ARCHITECT CA 19-9 Assay kit is substantially equivalent to the Fujirebio Diagnostics, Inc. CA 19-9 RIA. Both of the devices are IVD products and are indicated for the quantitative determination of CA 19-9 assay values (1116-NS-19-9 reactive determinants) and used in conjunction with other clinical methods in the management of pancreatic cancer patients.
A comparison of the features of the ARCHITECT CA 19-9xR assay device and the Fujirebio Diagnostics, Inc. CA 19-9 RIA follows.
2
| Abbott Laboratories | Fujirebio Diagnostics, Inc. | |
|---|---|---|
| ARCHITECT CA 19-9" xR Assay | CA 19-9™ RIA | |
| (Proposed Device) | (Predicate Device) | |
| K020566 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and | Class II, NIG | Class II, NIG |
| Product Code | ||
| Principle of Operation | Chemiluminscent Microparticle | Radioimmunoassay (RIA) |
| Immunoassay (CMIA) | ||
| Product Usage | Clinical and Hospitals laboratories | Clinical and Hospitals laboratories |
| Intended Use | The ARCHITECT® CA 19-9 xr | The Fujirebio Diagnostics CA 19- |
| assay is a chemiluminescent | 9 ™ RIA, an in vitro diagnostic test | |
| microparticle immunoassay | for the quantitative measurement | |
| (CMIA) for the quantitative | of the CA 19-9 tumor associated | |
| determination of 1116-NS-19-9 | antigen, in human serum or | |
| plasma, is indicated for the serial | ||
| reactive determinants in human | measurement of CA 19-9 to aid in | |
| serum or plasma on the | the management of patients | |
| ARCHITECT i System. The | diagnosed with cancers of the | |
| ARCHITECT CA 19-9xR assay is | ||
| to be used as an aid in the | exocrine pancreas. The test is | |
| management of pancreatic cancer | useful to aid in: | |
| patients in conjunction with other | Monitoring of disease status in | |
| clinical methods. | those patients having confirmed | |
| Patients known to be genotypically | pancreatic cancer who have levels | |
| negative for the Lewis blood group | of serum or plasma CA 19-9 above | |
| antigen will be unable to produce | the cutoff, at the time of diagnosis. | |
| the CA 19-9 antigen even in the | CA 19-9 values must be | |
| presence of malignant tissue. | interpreted in conjunction with all | |
| Phenotyping for the presence of | other clinical and laboratory data | |
| the Lewis antigen may be | before a medical decision is | |
| insufficient to detect true Lewis | determined. | |
| antigen negative individuals. | ||
| Even patients who are | ||
| genotypically positive for the | ||
| Lewis antigen may produce | ||
| varving levels of CA 19-9 based | ||
| on gene dosage effect. | Human Serum or Plasma (Citrate, | |
| Type of Specimen | Human serum or plasma (Sodium, | Heparin, ACD-A or EDTA) |
| Lithium or EDTA) | ||
| Routine Phlebotomy Techniques | Routine Phlebotomy Techniques | |
| Specimen Collection | ||
| Method | ||
| Capture Antibody | 1116-NS-19-9 mouse monoclonal | 1116-NS-19-9 mouse monoclonal |
| Conjugate Antibody | 1116-NS-19-9 (F(ab')2) mouse | 1116-NS-19-9 mouse monoclonal |
| monoclonal | ||
| Standards | 6 levels (0 - 1200 U/mL) | 6 levels (0 - 240 U/mL) |
| Controls | 3 levels (Low = 40 U/mL, Medium | 2 levels (Low = 40-50 U/mL, High |
| = 150 U/mL, High = 750 U/mL) | = 80-90 U/mL) | |
| Interpretation of Results | Calibrator Curve | Standard Curve |
3
Summary of Performance characteristics
Reproducibility:
Precision was determined as described in the National Committee for Clinical Laboratory Frecision was determinde as aboshibe in amples were tested consisting of two panels of Standards (NOOLO) 1 rollood LP ) . D = panel of serum to which 1116-NS-19-9 reactive determinants were added (panel 3), and the ARCHITECT CA 19-9xR Controls, using two lots uctemninatio word datos (panel of, wo separate times per day, for 20 nonconsecutive days or reagents, in rophiedlor of work lot used a single calibration curve throughout the study. on two maturnemo. Each teagoed by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.
The total precision %CV of the ARCHITECT CA 19-9xp assay was determined to be less than or equal to 10%.
Comparison Study
A total of 259 serum specimens were tested using the ARCHITECT CA 19-9xx assay and the Fujirebio Diagnostics, Inc. CA 19-9 RIA. Passing-Bablok linear regression analysis was r affebrook on all specimens (2.0 - 9115.7 U/mL for the ARCHITECT CA 19-9xR assay and 1.17 - 10,782 U/mL for the Fujirebio Diagnostics, Inc. CA 19-9 RIA).
Passing-Bablok linear regression analysis comparing the ARCHITECT CA 19-9xR assay to the Fujirebio Diagnostics, Inc. CA 19-9 RIA yielded a correlation coefficient of 0.96, a slope of 1.2 (99% confidence interval of 1.08, 1.37), and Y-axis intercept of -5.1 U/mL (99% confidence interval of -7.4, -3.4).
Reference Ranges:
Apparently Healthy Population:
The distribution of CA 19-9xR assay values determined in 360 serum specimens from apparently healthy individuals is shown in the table below:
| Distribution of ARCHITECT CA 19-9xR Values | ||||||
|---|---|---|---|---|---|---|
| Percent (%) | ||||||
| Number of | ||||||
| Subjects | 0 - 37.0 | |||||
| U/mL | 37.1 - 100 | |||||
| U/mL | 100.1 - 500 | |||||
| U/mL | 500.1 - 1200 | |||||
| U/mL | > 1200 U/mL | |||||
| Apparently | ||||||
| Healthy | ||||||
| Subjects | 360 | 94.4% | 5.6% | 0.0% | 0.0% | 0.0% |
In this study, 94.4% of the specimens from apparently healthy subjects (n=360) had values of 37 U/mL or less.
4
Patient Groups:
The distribution of CA 19-9 assay values determined in 978 individual serum samples from The distinution of OA 15-5 assuy Value doceminoun in the table below:
| Distribution of ARCHITECT CA 19-9XR Values | ||||||
|---|---|---|---|---|---|---|
| Number of Subjects | 0 - 37.0 U/mL | 37.1 - 100 U/mL | 100.1 - 500 U/mL | 500.1 - 1200 U/mL | > 1200 U/mL | |
| Nonmalignant Disease | ||||||
| Rectal Polyps | 33 | 97.0% | 3.0% | 0.0% | 0.0% | 0.0% |
| Pancreatitis | 3 | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| Gallbladder | 21 | 95.2% | 0.0% | 0.0% | 0.0% | 4.8% |
| Diabetes | 38 | 94.7% | 5.3% | 0.0% | 0.0% | 0.0% |
| Pulmonary | 40 | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| Cirrhosis | 153 | 92.8% | 4.6% | 0.7% | 0.7% | 1.3% |
| Hepatitis | 68 | 92.6% | 7.4% | 0.0% | 0.0% | 0.0% |
| Renal | 34 | 91.2% | 8.8% | 0.0% | 0.0% | 0.0% |
| Other | ||||||
| Gastrointestinal | 51 | 96.1% | 3.9% | 0.0% | 0.0% | 0.0% |
| Malignant Disease | ||||||
| Colorectal | 169 | 81.1% | 7.7% | 5.3% | 1.2% | 4.7% |
| Pancreatic | 66 | 43.9% | 6.1% | 12.1% | 10.6% | 27.3% |
| Gastric | 69 | 66.7% | 11.6% | 10.1% | 2.9% | 8.7% |
| Hepatocellular | 30 | 63.3% | 16.7% | 3.3% | 10.0% | 6.7% |
| Pulmonary | 70 | 84.3% | 5.7% | 4.3% | 1.4% | 4.3% |
| Mammary | 102 | 86.3% | 10.8% | 2.0% | 1.0% | 0.0% |
| Ovarian | 31 | 87.1% | 6.5% | 3.2% | 3.2% | 0.0% |
5
Pancreatic Cancer Serial Specimens
This analysis is based on 74 patients. There were a total of 261 evaluable observations. The average number of observations per patient is 3.5.
The average age of the subjects at time of diagnosis was 61.8 years (Exact 55% Cl: 59.5 The average age of the oubjock at the 85 years. Fifty-five percent (55% or 41/74) of the 74 years to o4.1 years) with a range of 17 try-five percent (45% or 33/74) were women. Staging patients were from the the romaining the 74 patients. The majority of the patients were stage was available from the churclor 10 of the 4.1% and 6.8% were stage 1 and 11 respectively.
Association between Change in Marker Value and Change in Disease State
A 2x2 table was constructed to show the association between a positive change in a patient's A 2x2 table was obnothed to the disease from one observation to the next. A positive OA 19-9 value and progression of the value that is at least 2.5 times greater than the total %CV of the test. For the test assay this value is 14.0%. The following Table (entitled "Distribution of W by V") presents the results for the 187 observation pairs in this study.
Three estimates of Concordance are given for the following Table.
| Total Concordance: | $C = (16+98) / 187 = 114/187 = 61.0%$ |
|---|---|
| Positive Concordance: | $C_{+} = 16/33 = 48.5%$ |
| Negative Concordance: | $C_{-} = 98/154 = 63.6%$ |
| Distribution of W by V | |||
|---|---|---|---|
| Change in CA 19-9 | |||
| (V) | Change in Disease State (W) | ||
| Progression | No Progression | Total | |
| ≥ 14.0% | 16 | 56 | 72 |