← Product Code [MOI](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/MOI) · K981698 # ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K981698) _Chiron Corp. · MOI · Jul 10, 1998 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/MOI/K981698 ## Device Facts - **Applicant:** Chiron Corp. - **Product Code:** [MOI](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/MOI.md) - **Decision Date:** Jul 10, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.6010 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The 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 using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also 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. ## Device Story Automated chemiluminescent immunoassay system; measures CA 27.29 antigen in human serum. Input: patient serum sample; process: competitive binding assay using mouse monoclonal antibody (MAb B27.29) labeled with acridinium ester and purified CA 27.29 coupled to paramagnetic particles; system performs automated pretreatment, incubation (7.5 min), separation, washing, and chemiluminescent reaction initiation. Output: relative light units (RLU) inversely proportional to CA 27.29 concentration; results reported by system. Used in clinical laboratory settings by trained personnel. Output aids clinicians in monitoring breast cancer recurrence and treatment response in metastatic disease. ## Clinical Evidence Bench testing only. Performance compared to predicate device using >875 clinical specimens from breast cancer patients. Range: 3.68 U/mL to 420 U/mL. Linear regression analysis: r2 > 0.99, slope 1.0408, y-intercept 0.9907 U/mL. Results demonstrate high correlation between modified and predicate assays. ## Technological Characteristics Fully automated competitive chemiluminescent immunoassay. Reagents: mouse monoclonal antibody (MAb B27.29) labeled with acridinium ester; solid phase: purified CA 27.29 coupled to paramagnetic particles. System performs automated sample/reagent dispensing, incubation, magnetic separation, washing, and chemiluminescence detection. Assay range: 3.5 U/mL to 450 U/mL. Operates on ACS:180 Automated Chemiluminescence System platform. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - ACS:180 BR ([K981698](/device/K981698.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS - ACS:180 BR This summary of safety and effectiveness information is being submitted in This Sunmary of Salety and Onotanonison of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR part 807.92. | Date of Summary Preparation: | May 13, 1998 | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Name: | Chiron Diagnostics Corporation
333 Coney Street
East Walpole, MA 02032 | | Company Contact: | Nancy A. Hornbaker
Regulatory Affairs
Chiron Diagnostics
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608
Telephone Number: 510.923.2758
FAX: 510.923.3703 | | Device Name: | ACS:180 BR
Automated Chemiluminescence System | | Common or Usual Name: | Automated Tumor Associated Antigen | | Classification: | Class II device | | Predicate Device: | ACS:180 BR | {1}------------------------------------------------ ### Intended Use and Indications for Use: The 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 using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also 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. #### Description of the Device: The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). After onboard pretreatment, the patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. The ACS: 180 system automatically performs the following steps: - dispenses sample and Pretreatment Reagent into a cuvette . - dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes u - separates, aspirates and washes the cuvettes - dispenses reagents which initiate the chemiluminescent reaction - = reports results An inverse relationship exists between the concentration of CA27.29 in a sample and the relative light units (RLU) detected by the system. #### Comparison to the Predicate Device The performance of the modified ACS:180 BR assay was compared to that of the predicate device in studies of over 875 specimens from breast cancer patients. These specimens had CA 27.29 levels that spanned the range from 3.68 U/mL to 420 U/mL. The results of the linear regression analysis indicated that the two methods were correlated. The coefficient of determination (r2) was greater than 0.99, the slope was 1.0408 and the y-intercept was 0.9907 U/mL. {2}------------------------------------------------ ## Comparison of Features | Feature | ACS:180 BR
(predicate device) | ACS:180 BR
(modified assay) | |-------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Specimen type | Serum | Serum | | Antigen | CA 27.29 | CA 27.29 | | Antibody | MAb B27.29 | MAb B27.29 | | Antibody Label | Acridinium Ester | Acridinium Ester | | Assay Principle | Competitive Immunoassay | Competitive Immunoassay | | Detection Method | Chemiluminescence | Chemiluminescence | | Calibration | Master Curve Card + 2
calibrators | Master Curve Card + 2
calibrators | | Assay Range | 3.5 U/mL to 450 U/mL | 3.5 U/mL to 450 U/mL | | Upper Limit of Normal* | 38.6 U/mL | 38.6 U/mL | | Population to be tested | Patients previously treated
for State II and Stage III
breast cancer; patients with
metastatic disease | Patients previously treated
for State II and Stage III
breast cancer; patients with
metastatic disease | | Assay Protocol
(Automated) | Dispense 25 µL sample | Dispense 25 µL sample +
22 µL Pretreatment
Reagent | | | Dispense 50 µL Lite
Reagent + 250 µL solid
Phase | Dispense 50 µL Lite
Reagent + 250 µL solid
Phase | | | Incubate 7.5 minutes | Incubate 7.5 minutes | | | Separate, aspirate, wash
cuvettes | Separate, aspirate, wash
cuvettes | | | Dispense 300 µL reagents
which initiate the
chemiluminescent reaction
Report results | Dispense 300 µL reagents
which initiate the
chemiluminescent reaction
Report results | *This ULN was determined during well-controlled clinical studies. As stated in the product's package insert, each laboratory should determine its own reference range(s). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 10 1998 Ms. Nancy A. Hornbaker Director Regulatory Affairs Chiron Corporation 4560 Horton St. Emeryville, California 94608 K981698 Re : ACS:180 BR Trade Name: Requlatory Class: II Product Code: MOI Dated: May 13, 1998 Received: May 14, 1998 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 Reqister. 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. {4}------------------------------------------------ Page 2 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). Other 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 Sutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ----- {5}------------------------------------------------ Page__________________________________________________________________________________________________________________________________________________________________________ | 510(k) Number (if known): | K981698 | |---------------------------|-------------| | Device Name: | ACS: 180 BR | # Indications For Use: CHIRON DIAGNOSTICS, CHIRON CORPORATION PREMARKET NOTIFICATION, ACS:180 BR May 1998 K981698 The 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 using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also 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. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![Signature](signature.jpg) | (Div! | | |-------|----------------| | Divi | | | 510 | evices K981698 | | Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use (Optional Format 1-2-96) | |---------------------------------------|--------------------------------------------------| |---------------------------------------|--------------------------------------------------| --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/MOI/K981698](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/MOI/K981698) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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