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510(k) Data Aggregation
(90 days)
IMMULITE**®** 2000 BR-MA
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of CA15-3 antigen in human serum and plasma, as an aid in the detection of recurrence in previously treated stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.
The IMMULITE® 2000 BR-MA assay was cleared under K013984. The components of the cleared assay were modified to reduce biotin interference. The modified IMMULITE® 2000 BR-MA Assay is comprised of the following components: BR-MA Bead Pack (L2BR12), BR-MA Reagent Wedge (L2BRA2) - Well 1, BR-MA Reagent Wedge (L2BRA2) - Well 2, and BR-MA Adjustors (LBRL, LBRH). The IMMULITE 2000 BR-MA is a solid-phase, two-step chemiluminescent immunometric assay. There are two incubation cycles of 30 minutes each. During the initial 30-minute cycle, the patient sample is incubated with biotinylated antibody coated bead (bead pack) and a buffer (reagent wedge well 1). The biotinylated antibody on the bead captures the antigen in the patient sample. On completion of the first 30-minute cycle, unbound sample/buffer are then removed via a centrifugal wash. During the second 30-minute cycle, alkaline phosphatase antibody conjugate in buffer (reagent wedge well 2) is added to complete the bead pair immunocomplex sandwich consisting of capture Ab-antigen-detection Ab. On completion of the second 30-minute cycle, unbound conjuqate is removed by centrifugal wash. The amount of alkaline phosphatase bound is directly proportional to the patient sample. Following the two 30-minute incubation periods. IMMULITE chemiluminescent substrate (L2SUBM) is added for a further 5-minute incubation period to generate the luminogenic reaction. The chemiluminescent substrate undergoes hydrolysis in the alkaline phosphatase to yield an unstable intermediate, which then emits photons. The sustained emissions are measured by the luminometer. The resulting relative light units are proportional to the concentration of CA15-3 in the sample, which is expressed as U/mL.
The retrieved document describes the acceptance criteria and performance of the IMMULITE 2000 BR-MA assay, which is a tumor-associated antigen immunological test system for CA15-3. The modifications to the device primarily focus on reducing biotin interference.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" against "reported device performance" in a single table. Instead, it presents performance characteristic studies that implicitly demonstrate the device meets certain standards. I've aggregated these into a table format below, using typical performance metrics for such devices. The "Acceptance Criteria" are implied by common laboratory standards (e.g., CLSI guidelines) and the successful outcome of the tests.
| Performance Metric | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Detection Limits | Determined in accordance with CLSI EP17-A2. | LoB = 0.21 U/mL, LoD = 0.30 U/mL, LoQ = 1 U/mL. |
| Linearity/Measuring Interval | Linearity across the assay range, ADL ≤ 15% at each level. | Confirmed across the assay range (1 - 300 U/mL) with acceptable ADL at each individual level. |
| Method Comparison | Strong correlation with the currently marketed device. | N=274 serum samples. Correlation Coefficients: Lot 1 ($Y = 0.98x + 0.71$) = 0.989; Lot 2 ($Y = 0.99x + 0.16$) = 0.992; Lot 3 ($Y = 1.04x - 0.79$) = 0.990. Statistical method: Passing-Bablok regression. |
| Assay Precision (Within-Lab) | %CV within acceptable limits for the assay. | 5 serum samples tested. %CV ranged from 7.1% to 7.4% (Total/Within-Lab). Within-Run %CV ranged from 4.8% to 6.8%. |
| Assay Reproducibility | %CV within acceptable limits across multiple lots and days. | 5 serum samples tested across 3 reagent lots. Total Reproducibility %CV ranged from 4.5% to 6.0%. |
| Recovery | Expected recovery within an acceptable range (e.g., 90-110%). | % Recovery for spiked samples ranged from 92% to 105%. |
| Interference | No significant interference from tested endogenous/exogenous substances up to specified concentrations. | No significant interference observed for Hemoglobin (381 mg/dL), Conjugated and Unconjugated Bilirubin (200 mg/L), Intralipid (3000 mg/dL), Biotin (3500 ng/mL), and several chemotherapy drugs (e.g., 5-Fluorouracil 1000 µg/mL). Note: The key improvement is reduced biotin interference from 100 ng/mL (predicate) to 3500 ng/mL. |
| Cross-Reactivity | No detectable cross-reactivity with specified tumor markers. | No detectable specificity (cross-reactivity) for Alpha-fetoprotein, CA125, CA19-9, and Carcinoembryonic Antigen at high concentrations. |
| Hook Effect | No hook effect within the assay range and beyond. | No hook effect observed up to 80,000 U/mL (well above the measuring interval of 300 U/mL). |
| Reference Range Verification | Verification of existing reference range with healthy samples. | 94% (65 out of 69) of normal female samples fell within the existing reference range (6.4 - 58 U/mL) across three lots. |
| Matrix Comparison | Comparable values across different specimen types. | Comparable values demonstrated for serum, Lithium Heparin, and EDTA plasma samples. |
2. Sample Size Used for the Test Set and Data Provenance
- Detection Limits (LoB, LoD, LoQ): The specific sample size for determining LoB, LoD, and LoQ is not explicitly stated as a number of individual patient samples, but the study was conducted "in accordance with CLSI EP17-A2," which provides methodologies for these determinations.
- Linearity/Measuring Interval: A high and low sample pool were used to prepare a panel of ten levels. The number of individual patient samples contributing to these pools is not specified.
- Method Comparison: 274 patient samples.
- Assay Precision: Five serum samples. Each tested in duplicate over 20 days, two runs per day (total 80 replicates per sample). Total N for data points is 400 (5 samples * 80 replicates).
- Assay Reproducibility: Five serum samples. Each tested over 5 days, with 5 replicates per sample (total 25 replicates per sample) across 3 reagent lots. Total N of data points is 375 (5 samples * 25 replicates * 3 reagent lots).
- Recovery: 5 neat samples spiked with 3 different concentrations of CA15-3 solution.
- Interference: Not specified as a number of patient samples, but various compounds were tested.
- Hook Effect: Not specified as a number of patient samples.
- Reference Range Verification: 69 apparently healthy female samples across 3 lots (total 207 results).
- Matrix Comparison: Not explicitly specified, but "comparable values to serum samples" were demonstrated across SST, Lithium Heparin, and EDTA tube types.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to human serum and plasma samples and "patient samples" and "apparently healthy female samples" without further geographical or temporal details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device. The IMMULITE 2000 BR-MA is an in vitro diagnostic assay that quantitatively measures CA15-3 antigen. Its performance characteristics are established through analytical studies (e.g., precision, linearity, interference) and comparisons to a predicate device or established laboratory methods, rather than through expert interpretation of outputs to establish a "ground truth" (as might be seen in imaging AI, for example). The ground truth for this device is the actual concentration of the analyte, verified through reference methods or spiked samples with known concentrations.
4. Adjudication Method for the Test Set
Not applicable. As described above, this device's performance is not evaluated through expert adjudication of results but rather by comparing its quantitative measurements to known values or to a predicate device, and assessing its analytical characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation system requiring human "readers." The "human reader" concept is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an automated in vitro diagnostic assay. Its primary function is to perform quantitative measurements of CA15-3. The performance studies described (detection limits, linearity, precision, etc.) are all standalone performance evaluations of the assay itself, without a "human-in-the-loop" component in the sense of interpreting an output that then needs human review for diagnosis. The device provides a quantitative result (U/mL), which is then used by a clinician in conjunction with other clinical methods. So, yes, the performance data presented are for the standalone analytical performance of the device.
7. The Type of Ground Truth Used
The ground truth used in the performance studies includes:
- Known concentrations: For linearity, recovery, interference, and hook effect studies, samples are often prepared with known concentrations of the analyte or interferents.
- Reference methods/Predicate device: For method comparison, results from the candidate device are compared against results from the legally marketed predicate device.
- Statistical methods: Established CLSI (Clinical and Laboratory Standards Institute) guidelines provide the statistical framework and generally accepted methodologies for determining metrics like LoB, LoD, LoQ, precision, and linearity.
- Clinically defined healthy populations: For reference range verification, samples from "apparently healthy female samples" are used.
8. The Sample Size for the Training Set
The document describes performance studies for a modified in vitro diagnostic assay. These studies are typically for verification and validation, not for "training" an algorithm in the sense of machine learning. There is no mention of a "training set" in the context of algorithm development or machine learning. The studies primarily evaluate the analytical performance of the modified assay components.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an algorithm, this question is not applicable. The device's mechanism is based on immunometric assay principles using chemical reactions, not on training data for a machine learning model.
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