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510(k) Data Aggregation
(57 days)
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
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.
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.
The provided text describes a 510(k) premarket notification for a modified in vitro diagnostic device, the ACS:180 BR, which is an automated chemiluminescence system for detecting cancer antigen CA 27.29 in human serum.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather focuses on demonstrating "substantial equivalence" to a predicate device. The primary performance metric reported is the correlation between the modified assay and the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance | Comments |
|---|---|---|---|
| Correlation ($r^2$) | A high coefficient of determination, ideally close to 1, demonstrating a strong linear relationship with the predicate device. | $>0.99$ | This indicates a very strong positive linear correlation between the modified and predicate assays. |
| Slope | A slope close to 1, indicating that the modified assay measures values very similarly to the predicate device across the range. | $1.0408$ | Close to 1, suggesting good agreement in the rate of change between the two methods. |
| Y-intercept | A Y-intercept close to 0, indicating minimal constant bias between the modified assay and the predicate device. | $0.9907$ U/mL | Relatively close to 0, suggesting a small positive bias but overall good agreement with the predicate. |
| Assay Range | Must match the predicate device to ensure comparable applicability. | $3.5$ U/mL to $450$ U/mL | Matches the predicate device. |
| Upper Limit of Normal | Must match the predicate device, as it defines the clinical cutoff. | $38.6$ U/mL | Matches the predicate device, with a note that individual labs should determine their own reference ranges. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Over 875 specimens.
- Data Provenance: The document does not specify the country of origin. It does not explicitly state whether the data was retrospective or prospective, but it implies a retrospective comparison of previously collected specimens, given the statement "These specimens had CA 27.29 levels that spanned the range from 3.68 U/mL to 420 U/mL."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The study described is a method comparison study between a modified device and a predicate device, not typically requiring expert-established "ground truth" in the same way an imaging or diagnostic AI device would. The "ground truth" here is the measurement provided by the existing, legally marketed predicate device. Therefore, no information is provided regarding expert qualifications or the number of experts used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of measurements between two diagnostic assays, not a study requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is a comparison between two automated diagnostic assays, not a study involving human readers or AI assistance for interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this was a standalone performance comparison study of the device (an automated chemiluminescence system) against its predicate device. The results reported are for the device (modified assay) performing on its own, without human intervention in the measurement process beyond standard laboratory procedures.
7. The Type of Ground Truth Used
The "ground truth" for this comparative study was the results obtained from the predicate device (the original ACS:180 BR assay). The objective was to show that the modified assay yielded results substantially equivalent to the established predicate.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device modification, where performance is typically validated through comparison to a well-established method, not through machine learning training and testing paradigms. Therefore, information on a training set size is not applicable/provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the machine learning sense) is described or implied for this type of device validation.
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(164 days)
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
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.
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. Automatic dilution is available on the ACS:180® for the ACS:180 BR assay.
Here's a breakdown of the acceptance criteria and study information for the Chiron Diagnostics ACS:180 BR device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytical Sensitivity |
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