(58 days)
CODA is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use. The system is open, such that a variety of microplate-based enzyme immunoassays (EIA's) can be programmed and run on the instrument. The sample and reagent pipettes, incubator, washer, reader and robotics are housed in the compact benchtop unit. CODA Operation and Data Management software operates in the Windows 95 environment utilizing icon-based commands for operator ease of use.
The Bio-Rad Coda Automated EIA Analyzer (Coda) is a compact, integrated immunoassay system designed for the automation of microplate based (8 wells by 12 strips) chemistries. The sampler, plate-shaker, incubator, washer, reader and robotics are housed in a single compact Main Unit. An external computer handles the operation and data management using software contained on a CD-ROM which operates in the Windows 95 environment.
Enzyme immunoassay (EIA) typically involves the addition of a defined volume of sample to a series of plastic microtitre wells which have been pre-coated with antigen or antibody. The wells are sometimes washed to remove unbound ligand before addition of enzyme conjugate to each well. After incubation, substrate is added followed by a second incubation. The enzyme reaction is "stopped" and the colored reactant product is measured by absorbance at a defined wavelength. The absorbance values of the unknowns are compared to absorbance of calibrators to determine the concentration of the ligand in the sample. The Coda provides an integrated, automated approach to carrying out the above steps all under control of the computer and associated software. All the steps may be programmed into a complete protocol or individual steps may be performed in a manual mode. The Coda is therefore virtually usable with any assay kit using microtite plates. Output from the spectrophotometer is measured by the computer. Calculation, curve-fitting, result interpretation and other aspects of data management and analysis are automatically performed by the software algorithms.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Coda™ Automated EIA Analyzer:
Please note: The provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for a novel device. As such, some of the information requested (especially regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth for training) may not be fully addressed, as these types of studies might not be explicitly required or detailed in a 510(k) for this type of instrument.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied/Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-Run %CV (Low Control) | (Likely compared to predicate or internal standards for acceptable variability) | 8.6% |
| Within-Run %CV (Mid-Range Control) | (Likely compared to predicate or internal standards for acceptable variability) | 7.1% |
| Within-Run %CV (High Control) | (Likely compared to predicate or internal standards for acceptable variability) | Consistently > 25 ulU/mL |
| Within-Run %CV (Anemia Control) | (Likely compared to predicate or internal standards for acceptable variability) | 9.5% |
| Total Precision %CV (Low Control) | (Likely compared to predicate or internal standards for acceptable variability) | 9.6% |
| Total Precision %CV (Mid-Range Control) | (Likely compared to predicate or internal standards for acceptable variability) | 7.7% |
| Total Precision %CV (High Control) | (Likely compared to predicate or internal standards for acceptable variability) | Consistently > 25 ulU/mL |
| Total Precision %CV (Anemia Control) | (Likely compared to predicate or internal standards for acceptable variability) | 14.0% |
| Sensitivity (Measuring Range) | (Likely compared to predicate for comparable analytical detection) | 0.034 ulU/mL (lowest TSH distinguishable from zero standard at 95% CI) |
| Accuracy (Correlation) | High correlation required (e.g., r > 0.95 or 0.97) to demonstrate substantial equivalence to predicate device. | r = 0.995 (compared to Bio-Rad Radias Immunoassay System) |
| Carry-over | (Not specified, but tested) | Not explicitly quantified in this summary |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for each performance metric. Instead, the performance is presented to demonstrate that the device is "substantially equivalent" to predicate devices, implying that its performance is comparable and acceptable within the context of similar devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Precision Studies: Twenty samples each of low, mid-range, and high control, plus a Bio-Rad anemia control (AN) were analyzed. This means at least 4 x 20 = 80 measurements were taken for precision.
- Correlation Study (Accuracy): 111 samples were used.
- Data Provenance: Not specified, but generally, studies for 510(k) submissions in the US are conducted in a controlled lab environment. It is unclear if the samples were retrospective or prospective, or their country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For an automated immunoassay analyzer, the "ground truth" for test samples is typically established by reference methods or validated laboratory measurements, not by human experts in the same way it would be for an image-based diagnostic AI.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. The testing involved comparing instrument readings to established values or to a predicate device, not adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- No, a MRMC study was not done. This type of study is typically performed for AI-powered diagnostic aids where human interpretation is a key component. The Coda is an automated immunoassay analyzer, not an AI for human-in-the-loop diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the studies described are standalone performance studies. The device (Coda™ Automated EIA Analyzer) itself is an automated system. The precision, sensitivity, and accuracy studies evaluate the instrument's performance autonomously. There is no "human-in-the-loop" component for its direct operation or result interpretation at the point of measurement; the human's role is to program assays and manage data.
7. The Type of Ground Truth Used:
- For Precision: Control samples (low, mid-range, high, and anemia control) with established target values.
- For Sensitivity: Zero standard (to determine the lowest distinguishable level).
- For Accuracy (Correlation): Measurements obtained from the predicate device, the Bio-Rad Radias Immunoassay System, for the same 111 samples. The predicate device's results served as the reference for comparison.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. The Bio-Rad Coda™ Automated EIA Analyzer is an immunoassay instrument and does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense for algorithm development. Its software manages the instrument's operations, calculations, and data interpretation based on predefined algorithms for curve-fitting and result interpretation, not on learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. As explained in #8, there isn't a "training set" in the AI/ML context for this type of device. The ground truth for its operational parameters and calculation algorithms would be based on fundamental scientific principles of enzyme immunoassays, photometric measurements, and validated statistical methods for curve fitting, rather than a dataset trained by external ground truth.
§ 862.2500 Enzyme analyzer for clinical use.
(a)
Identification. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.