(164 days)
Biomira TRUQUANT® BR™ RIA PMA P950011
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No
The description details a standard in vitro diagnostic immunoassay and automated system, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic test used to measure cancer antigen CA 27.29 in human serum. It is intended to aid in the management of breast cancer patients by monitoring disease progression or regression, not to treat the disease itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test." The description details its use for quantitative determination of a cancer antigen to aid in the management of breast cancer patients, which is a diagnostic purpose.
No
The device description clearly outlines a chemiluminescent assay involving reagents (Lite Reagent, Solid Phase) and paramagnetic particles, which are physical components, not software. It is intended for use on an automated system (ACS:180) which is also hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum."
- Device Description: The description details a laboratory assay that analyzes a human sample (serum) using reagents and a specific instrument (ACS:180) to measure a biological marker (CA 27.29). This is the core function of an in vitro diagnostic device.
- Clinical Context: The test is intended for use in the management of breast cancer patients by monitoring disease progression or regression, which is a clinical application of diagnostic testing.
- Performance Studies: The document includes performance data like sensitivity, specificity, and correlation with a predicate device, which are standard metrics for evaluating the performance of IVDs.
- Predicate Device: The mention of a "Predicate Device" (P950011 Biomira TRUQUANT® BR™ RIA) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared or approved IVD.
N/A
Intended Use / Indications for Use
Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum. The test is intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Product codes
MOI
Device Description
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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 Trial Results
Study type: Prospective Clinical Trial
Sensitivity to Change in Disease Status: 73%
Specificity to Change in Disease Status: 71%
Positive Predictive Value to Change in Disease Status: 77%
Negative Predictive Value to Change in Disease Status: 67%
Analytical Sensitivity
§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
Date of Summary Preparation: July 24, 1997
- Company Name: Chiron Diagnostics Corporation 1401 Harbor Bay Parkway Alameda, CA 94502
- Company Contact: Nancy Hombaker Regulatory Affairs Chiron Diagnostics Chiron Corporation 4560 Horton Street Emeryville, CA 94608
| Telephone Number: | 510.923.2758 |
|---|---|
| Fax: | 510.923.3344 |
- Device Name: ACS:180 BR Automated Chemiluminescence System
- Common or Usual Name: Automated Tumor Associated Antigen
- Classification: Class II device
- Predicate Device: Biomira TRUQUANT® BR™ RIA PMA P950011
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SUMMARY OF SAFETY AND EFFECTIVENESS - K970695 (continued)
Intended Use and Indications for Use:
Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum. The test is intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Summary and Explanation of the Test:
Automatic dilution is available on the ACS:180® for the ACS:180 BR assay. Any sample initially reading with a value higher than the assay range will be rescheduled by the instrument for an automatic dilution. The ACS:180 has the capacity to aspirate as low as 5 ul of sample using the sample probe. Given the sample volume of 25 ul for ACS:180 BR, the maximum dilution that is possible is a 1:5. The instrument will aspirate 5 ul of sample and add 20 ul of diluent to maintain the 25 ul sample size. Instrument operation will then proceed as usual,
Principle of the Assay:
The Chiron Diagnostics ACS:180 BR assay is a competitive, chemiluminescent assay intended for use on the Chiron Diagnostics Automated Chemiluminescent System (ACS). One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The Solid Phase is composed of purified breast cancer antigen covalently coupled to paramagnetic particles (PMP). The patient serum sample is incubated with both reagents simultaneously for 7.5 minutes.
An inverse relationship exists between the concentration of CA 27.29 in a sample and the relative light units (RLU) detected by the ACS:180 system.
| Analytical Sensitivity | Upper Limit of Normal (ULN) 38.6 U/mL
Specificity of the Assay
The specificity of the assay was determined by testing serum samples from patients with active malignancies other than breast and serum from patients with other diseases and conditions. Results from the clinical study are presented below.
Patients with non breast malignancies frequently have raised levels of the CA 27,29 antigen as indicated by their specificities. CA 27.29 is normally expressed by most epithelial tissues and over-expressed by many epithelial cancers. It is not a breast specific antigen.
Specificity of the ACS180:BR in Patients with Malignancies other than Breast
| Malignancy | N | Specificity |
|---|---|---|
| Colon | 43 | 74.4% |
| Liver | 20 | 45.0% |
| Lung | 47 | 57.5% |
| Ovary | 50 | 44.0% |
| Pancreas | 45 | 53.3% |
| Prostate | 34 | 82.4% |
| Stomach | 29 | 93.1% |
| Uterus | 30 | 86.7% |
Specificity of the ACS:180 BR in Patients with Other Diseases And Conditions
| Condition | N | Specificity |
|---|---|---|
| Benign Breast Disease | ||
| Breast Adenoma | 61 | 95.08% |
| Fibrocystic Breasts | 68 | 98.53% |
| Cirrhosis | 25 | 76.00% |
| Endometriosis | 24 | 91.67% |
| Lactating Woman | 37 | 89.19% |
| Mild Chronic Hepatitis | 28 | 85.71% |
| Ovarian Cyst | 50 | 94.00% |
| Pregnancy | 49 | 97.96% |
| Renal Impairment | 20 | 85.00% |
| Severe Chronic Hepatitis | 20 | 95.00% |
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SUMMARY OF SAFETY AND EFFECTIVENESS - K970695 (continued)
Potentially Interfering Substances
There are no known cross-reactants for CA 27.29 as measured by the ACS:180 BR assay.
The potential interference of chemotherapeutic agents, therapeutic drugs, and tumor marker antigens was tested by adding these substances to five serum pools containing CA 27.29 ranging from 20.0 to 445.8 U/mL. The level of CA 27.29 in each of these pools was then determined using the ACS:180 BR assay and normalized to the level without the respective drugs or antigens.
| Substance | Mean %
Recovery | Substance | Mean %
Recovery |
|---------------------------|--------------------|----------------------------|--------------------|
| Acetaminophen (10X) | 96.3 | Granisetron HCI (10X) | 99.9 |
| Cimetidine (40X) | 100.9 | Lorazepam (10X) | 98.0 |
| Ciprofloxacin (10X) | 100.1 | Megestrol acetate (5X) | 105.2 |
| Codeine (10X) | 96.9 | Methotrexate (10X) | 105.8 |
| Cyclophosphamide (1X) | 96.2 | Morphine (10X) | 95.6 |
| Dexamethasone (10X) | 100.2 | Ondansetron (10X) | 93.3 |
| Diphenhydramine HCI (10X) | 101.8 | Paclitaxel (2X) | 101.7 |
| Doxorubicin (10X) | 95.9 | Prochlorperazine (10X) | 96.4 |
| Etopside (2X) | 99.5 | Tamoxifen (10X) | 96.6 |
| 5-Fluorouracil (10X) | 104.2 | Vinorelbine tartrate (10X) | 104.9 |
| Antigen | Mean % Recovery |
|---|---|
| Carcinoembryonic antigen | |
| (CEA) | 103.8 |
| Ovarian Cancer antigen | |
| (CA125) | 105.9 |
| GI Cancer antigen | |
| (CA 19.9) | 103.6 |
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Correlation with Predicate Device
The performance of the ACS: 180 BR assay was compared with that of the predicate device in a study of 203 specimens. These specimens had CA 27.29 levels that spanned the range from 7 to 994 U/mL, The results of the linear regression analysis indicated that the two methods were correlated. The correlation coefficient (r) was 0.96; the slope was 1.05 and y-intercept was 6 U/mL.
The CA 27.29 results from a subset of this population, 103 women with histologically confirmed breast cancer, were also highly correlated (r = 0.96). In this analysis, the slope was 1.04 and the y-intercept was 8 U/mL.
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, one behind the other, creating a sense of depth and unity.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Hornbaker Requlatory Affairs Chiron Diagnostics Chiron Corporation 4560 Horton Street Emeryville, California 94608
Re : K970695/S1 Trade Name: ACS:180 BR Requlatory Class: II Product Code: MOI Dated: June 13, 1997 Received: June 16, 1997
Dear Ms. Hornbaker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
AUG - 8 1997
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Qther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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501(k) Number (if known):
Device Name: ACS: 180 BR
Indications For Use:
Chiron Diagnostics ACS: 180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum. The test is intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Peter E. Madson
(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Prt 21 CFR 801.109
OR
Over-the-Counter Use