(82 days)
Not Found
No
The description details a standard immunoassay technology (CMIA) and its performance characteristics. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function within the device or assay.
No.
The device is used for in vitro diagnostic purposes to measure a biomarker (CA 15-3) as an aid in managing breast cancer patients; it does not directly treat or prevent the disease.
Yes
This device is used for the quantitative determination of a specific antigen to aid in the management of breast cancer patients, and its performance studies highlight its use in comparison to another assay, indicating its diagnostic nature.
No
The device description clearly outlines a Chemiluminescent Microparticle Immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a physical system (ARCHITECT i optical system) to measure light units. This is a hardware-based assay, 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 DF3 defined antigen in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "two-step immunoassay" using "human serum or plasma," further confirming the in vitro nature of the testing.
- Performance Studies: The performance studies involve testing "serum specimens" and "defibrinated plasma based panel members," which are biological samples tested in vitro.
- Predicate Device: The predicate device is the "AxSYM® CA 15-3® Assay," which is also an IVD for the same purpose.
All these points clearly indicate that the ARCHITECT CA 15-3 assay is designed to perform diagnostic tests on biological samples outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
The ARCHITECT CA 15-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.
The ARCHITECT CA 15-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.
Product codes (comma separated list FDA assigned to the subject device)
MOI, JIT, JJX
Device Description
The ARCHITECT CA 15-3 assay is a two-step immunoassay to determine the presence of DF3 reactive determinants in human serum or plasma, using Chemiluminescent Microparticle Immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex™.
In the first step, sample, wash buffer and 115D8 coated paramagnetic microparticles are combined. DF3 reactive determinants present in the sample bind to the 115D8 coated microparticles. After washing, DF3 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of DF3 reactive determinants in the sample and the RLUs detected by the ARCHITECT i optical system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and Hospital 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
Not Found
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. Five defibrinated plasma based panel members were tested, in replicates of two, at two separate times per day, for 20 days. Testing was performed on 2 instruments using 2 lots of reagents and a single calibration per instrument. The total precision was determined by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample. The total precision %CV of the ARCHITECT CA 125 II assay was determined to be less than or equal to 8%.
Comparison Study:
A total of 402 serum specimens, of which 250 serum specimens were from patients diagnosed with breast cancer (stage I through stage IV), were tested using the ARCHITECT CA 15-3 assay and the AxSYM CA 15-3 assay. Passing-Bablok linear regression analyses was performed on all specimens with concentration values within the dynamic range of both assays (0.0-1326.5 U/mL for the ARCHITECT CA 15-3 assay and (4.9-1621.9 U/mL for the AxSYM CA 15-3 Assay).
Passing-Bablok linear regression analysis comparing the ARCHITECT CA 15-3 assay to the AxSYM CA 15-3 assay yielded a correlation coefficient of 0.980, a slope of 0.94 (99% confidence interval of 0.92, 0.97), and Y-axis intercept of - 0.3 U/mL (99% confidence interval of -0.9, 0.0).
Reference Ranges:
Apparently Healthy Population: The distribution of CA 15-3 assay values determined in 396 normal individual specimens. In this study, 99.0% of the healthy female subjects had CA 15-3 assay values at or below 31.3 U/mL. (mean = 13.0, SD = 7.0)
Patient Groups: The distribution of CA 15-3 assay values determined in 569 specimens from various diseases: Ovarian Cancer (120 subjects), Colorectal Cancer (50 subjects), Lung Cancer (50 subjects), Breast Disease (100 subjects), Ovarian Disease (100 subjects), Urogenital Disease (49 subjects), Pregnancy (50 subjects), Hypertension/CHD (100 subjects).
Breast Cancer Serial Specimens:
Analysis based on 74 evaluable patient's samples, with 377 evaluable observations. The average number of observations per patient is 5.1. The average age of the women in this cohort at time of diagnosis was 48 years. Forty-seven percent of the women were post-menopausal at time of diagnosis. Stage was available for 61 women. Sixty-four percent of the cohort was evenly split between stage II with 23% of the woman having stage IV disease.
Association between Change in Marker Value and Change in Disease State: A 2x2 table constructed showing the association between a positive change in a patient's CA15-3 value (an increase of at least 2.5 times greater than the total %CV of the test, which is 9.575%) and progression of the disease. This was performed for 303 observation pairs.
Total Concordance: C = ((50+153)/303) x 100 = 66.9%
Positive Concordance: C+ = (50/66) x 100 = 75.7%
Negative Concordance: C- = (153/237) x 100 = 64.5%
Per Patient Analysis: Distribution for the 74 patients. Estimates of per-patient concordances can be obtained, and confidence intervals determined using the binomial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total Precision %CV:
§ 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
5042732
DEC 2 2 2004
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Kimberly Peterson, (610) 240-3828 |
| Summary preparation date: | September 30, 2004 |
| Name of Device | |
| Trade/Proprietary Name: | ARCHITECT® CA 15-3® Assay |
| Common/Usual Name: | CA 15-3 Assay |
| Classification Name: | System, Test, Immunological, Antigen, Tumor |
| Predicate Device | |
AxSYM® CA 15-3® Assay
Device Description
The ARCHITECT CA 15-3 assay is a two-step immunoassay to determine the presence of DF3 reactive determinants in human serum or plasma, using Chemiluminescent Microparticle Immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex™
In the first step, sample, wash buffer and 115D8 coated paramagnetic microparticles are combined. DF3 reactive determinants present in the sample bind to the 115D8 coated microparticles. After washing, DF3 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the cresulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of DF3 reactive determinants in the sample and the RLUs detected by the ARCHITECT i *optical system.
1
For additional information on system and assay technology, refer to the ARCHITECT i System Operations Manual, Section 3.
*i =immunoassay
Intended Use
Reagent Kit
The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CA 125 reactive determinants in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 II assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Calibrator Kit
The ARCHITECT CA 125 II Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and Refer to the ARCHITECT CA 125 Il reagent package insert for additional plasma. information.
Control Kit
The ARCHITECT CA 125 II Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 125 Il reagent package insert for additional information.
Statement of Substantial Equivalence
The ARCHITECT CA 15-3 Assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and Stage III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
ARCHITECT CA 15-3 Assay kit is substantially equivalent to the AxSYM® CA 15-3° Assay manufactured by Abbott Laboratories. Both of the devices are IVD products and are indicated for the quantitative determination of CA 15-3 assay values (DF3 defined antigen) in human serum and plasma, as an aid in the management of Stage III and Stage III breast cancer patients.
A comparison of the features of the ARCHITECT CA 15-3 Assay device and the AxSYM CA 15-3 Assay follows.
2
| | Abbott Laboratories
ARCHITECT CA 15-3 Assay
(Proposed Device) | Abbott Laboratories
AxSYM® CA 15-3® Assay
(Predicate Device)
K963926 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and
Product Code | Class II, MOI | Class II, MOI |
| Principle of
Operation | Chemiluminscent Microparticle
Immunoassay (CMIA) | Microparticle Enzyme
Immunoassay (MEIA) |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital
laboratories |
| Intended Use | The ARCHITECT CA 15-3 Assay
is a chemiluminescent
microparticle immunoassay
(CMIA) for the quantitative
determination of DF3 defined
antigen in human serum and
plasma on the ARCHITECT i
System. The ARCHITECT CA
15-3 assay is to be used as an
aid in the management of Stage
II and Stage III breast cancer
patients. Serial testing for patient
CA 15-3 assay values should be
used in conjunction with other
clinical methods for monitoring
breast cancer. | The AXSYM CA 15-3 Assay is
a microparticle enzyme
immunoassay (MEIA) for the
quantitative measurement of
CA 15-3 assay values in
human serum and plasma
(EDTA) to aid in the
management of Stage II and
Stage III breast cancer
patients. Serial testing for
patient CA 15-3 assay values
should be used in conjunction
with other clinical methods for
monitoring breast cancer. |
| Type of Specimen | Human serum or plasma (EDTA,
Lithium Heparin, Sodium
Heparin) | Human Serum or plasma
(EDTA) |
| Specimen
Collection Method | Routine Phlebotomy Techniques | Routine Phlebotomy
Techniques |
| Analyte Detected | Breast carcinoma-associated
mucin antigen encoded by the
MUC 1 gene | Breast carcinoma-associated
mucin antigen encoded by the
MUC 1 gene |
| Capture Antibody | 115D8 mouse monoclonal | 115D8 mouse monoclonal |
| Conjugate Antibody | DF3 mouse monoclonal | DF3 mouse monoclonal |
| Calibrators | 6 levels (0 - 800 U/mL ) | 6 levels (0 - 250 U/mL) |
| Controls | 2 levels (Low = 40 U/mL, High =
250 U/mL) | 2 levels (Low = 35 U/mL, High
= 150 U/mL) |
| Interpretation of
Results | Standard Curve | Standard Curve |
3
Summary of Performance characteristics
Reproducibility:
Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Five defibrinated plasma based panel members (1, 2, 3, 4 and 5) were tested, in replicates of two, at two separate times per day, for 20 days. Testing was performed on 2 instruments (both instruments are located at FDI) using 2 lots of The total precision was determined by reagents and a single calibration per instrument. calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.
The total precision %CV of the ARCHITECT® CA 125 II™ assay was determined to be less than or equal to 8%.
Comparison Study
A total of 402 serum specimens, of which 250 serum specimens were from patients diagnosed with breast cancer (stage I through stage IV), were tested using the ARCHITECT CA 15-3 assay and the AxSYM CA 15-3 assay. Passing-Bablok linear regression analyses was performed on all specimens with concentration values within the dynamic range of both assays (0.0-1326.5 U/mL*) for the ARCHITECT CA 15-3 assay and (4.9-1621.9 U/mL*) for the AxSYM CA 15-3 Assay.
Passing-Bablok linear regression analysis comparing the ARCHITECT CA 15-3 assay to the AxSYM CA 15-3 assay yielded a correlation coefficient of 0.980, a slope of 0.94 (99% confidence interval of 0.92, 0.97), and Y-axis intercept of - 0.3 U/mL (99% confidence interval of -0.9, 0.0).
Reference Ranges:
Apparently Healthy Population:
The distribution of CA 15-3 assay values determined in 396 normal individual specimens is shown in the table below:
Distribution of ARCHITECT CA 15-3 Assay Values | |||||
---|---|---|---|---|---|
Number of | |||||
Subjects | 0-31.3 | ||||
U/mL | 31.4-60 | ||||
U/mL | 60.1-120 | ||||
U/mL | >120 | ||||
U/mL | |||||
Apparently Healthy | |||||
Females (Pre Menopausal) | 99 | 99.0 | 1.0 | 0.0 | 0.0 |
Females (Post Menopausal) | 100 | 99.0 | 0.0 | 1.0 | 0.0 |
Males | 197 | 98.5 | 1.5 | 0.0 | 0.0 |
In this study. 99.0% of the healthy female subjects had CA 15-3 assay values at or below 31.3 U/mL. (mean = 13.0, SD = 7.0)
4
Patient Groups:
The distribution of CA 15-3 assay values determined in 569 specimens from various diseases is shown in the table below:
Distribution of ARCHITECT CA 15-3 Assay Values | |||||
---|---|---|---|---|---|
Percent (%) | |||||
Number of | |||||
Subjects | 0-31.3 | ||||
U/mL | 31.4-60 | ||||
U/mL | 60.1-120 | ||||
U/mL | >120 | ||||
U/mL | |||||
Malignant Conditions | |||||
Ovarian Cancer | 120 | 76.7 | 13.3 | 4.2 | 5.8 |
Colorectal Cancer | 50 | 96.0 | 4.0 | 0.0 | 0.0 |
Lung Cancer | 50 | 78.0 | 14.0 | 4.0 | 4.0 |
NonMalignant Conditions | |||||
Breast Disease | 100 | 97.0 | 3.0 | 0.0 | 0.0 |
Ovarian Disease | 100 | 99.0 | 1.0 | 0.0 | 0.0 |
Urogenital Disease | 49 | 84.0 | 16.0 | 0.0 | 0.0 |
Pregnancy | 50 | 100.0 | 0.0 | 0.0 | 0.0 |
Hypertension/CHD | 100 | 94.0 | 6.0 | 0.0 | 0.0 |
Breast Cancer Serial Specimens
This analysis is based on 74 evaluable patient's samples. There were a total of 377 evaluable observations. The average number of observations per patient is 5.1.
The average age of the women in this cohort at time of diagnosis was 48 years (Exact 95% Cl: 45.3 years to 48.9 years). Forty-seven percent of the women were post-menopausal at time of diagnosis. Stage was available from the charts for 61 women. Sixty-four percent of the cohort was eventy split between stage II with 23% of the woman having stage IV disease.
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 CA15-3 value and progression of the disease from one observation to the next. A positive change in CA15-3 is defined as an increase in the value that is at least 2.5 times greater than the total %CV of the test. For the test assay this value is 9.575%. The following Table (entitled "Distribution of W by V") presents the results for the 303 observation pairs in this study.
Three estimates of Concordance are given for the following Table.
Total Concordance: $C = \frac{50+153}{303}$ ×100 = 66.9% 303
133
5
$$\text{Positive Consordance: } C_\star = \frac{50}{66} \times 100 = 75.7%$$
153 ×100 = 64.5% Negative Concordance: $C_ =$ 237
Distribution of W by V
Change in Disease State (W) | |||
---|---|---|---|
Change in CA15-3 (V) | Progression | No Progression | Total |
≥9.575% | 50 | 84 | 134 |
Estimate of Per-Patient Positive, Negative and Total Concordance With 95% Confidence intervals |
| Statistic | stimate | ower
Bound | Bound |
|-----------|---------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 00 201
00.0 |
| | | | real and and the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first th |
| | | | |
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 2004
Ms. Kimberly M. Peterson Director, Clinical and Regulatory Affairs Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy. Malvern, PA 19355
K042732 Trade/Device Name: ARCHITECT® CA 15-3® Assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: MOI, JIT, JJX Dated: September 30, 2004 Received: October 4, 2004
Dear Ms. Peterson:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
7
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quebtens on the price Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert H. Beckeysh
Robert L. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Device Name: ARCHITECT® CA 15-3® Assay
Indications for Use:
ARCHITECT CA 15-3 Reagent Kit
The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used prooms on the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
ARCHITECT CA 15-3 Calibrator Kit
The ARCHITECT CA 15-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.
ARCHITECT CA 15-3 Control Kit
The ARCHITECT CA 15-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert H. Beckerf
Laboratory Devices
510(k) Number
Page 1 of Updated August 30, 2004