(167 days)
The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes that may bbe adaptable to the below analyzers depending on the reagents used.
The cobas c701 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The cobas c502 analyzer is a fully automated discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The cobas 8000 ISE module is a fully automated ion- specific analyzer intended for the in vitro potentiometric determination of chloride, potassium and sodium in serum and plasma using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
IGA-2 is an in vitro test for the quantitative determination of IgA in human serum and plasma on Roche/Hitachi cobas c systems. IgA measurements aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (cobas 8000 ISE module) and photometric analysis modules (cobas c 701 and c 502 modules). The cobas c 701 and c 502 analyzer modules are new members of the Roche / Hitachi family of clinical chemistry analyzers.
The cobas 8000 ISE module is an Ion-selective electrode system for the determination of sodium, potassium and chloride in serum and plasma.
The cobas c 701 module is a fully automated, discreet, computerized instrument for in vitro tests on a wide range of analytes. It is designed to use serum/plasma, urine, CSF supernatant and whole blood sample types. The related sample buffer module offers a random access buffer function for samples.
The cobas c 502 module is analytically identical to the cobas c 501 module (cobas 6000 analyzer series. K060373), but without an integrated ISE module. The related sample buffer module offers a random access buffer function for samples.
The cobas 8000 Data Manager acts as a command/control center between the cobas 8000 instrument and the LIS. The data manager software is installed on a PC. It also provides enhanced sample tracking, test management, result traceability, storage and reporting, quality control and calibration management, has LIS backup functionality and serves as a robust storage location for the instrument.
The control unit uses a graphical user interface to control all instrument functions, and is comprised of a touch screen monitor, keyboard and mouse and a personal computer.
The core unit is comprised of several components that manage conveyance of samples to each assigned analytical module. The actual composition of the core unit depends on the configuration of the analytical modules. Features of the Core Unit include a barcode reader (for racks and samples), automatic tube position if barcode position is misaligned, system power switch and circuit breaker, the sample rack loader/unloader, a STAT port, a water supply and a system interface port.
The Roche cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis. The submission focuses on modifications to the predicate device (cobas 6000 Analyzer Series).
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated through application testing based on a risk analysis. While specific quantitative acceptance criteria are not explicitly detailed for each test, the general statement is that "All testing met specifications." This implies that the observed performance was acceptable for each parameter.
Here’s a table summarizing the tests and the reported performance (where available):
| Test Type | Analyte(s) Tested | Reported Device Performance |
|---|---|---|
| In-run Precision | IgA, Sodium, Potassium, Chloride | Met specifications |
| Between-day Precision | IgA, Sodium, Potassium, Chloride | Met specifications |
| Linearity | IgA, Sodium, Potassium, Chloride | Met specifications |
| Recovery of Controls | IgA, Sodium, Potassium, Chloride | Met specifications |
| Method Comparison | IgA (compared to c501) | Met specifications |
| Method Comparison | Sodium, Potassium (compared to c501 and flame) | Met specifications |
| Method Comparison | Chloride (compared to c501 and coulometry) | Met specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes used for the test set. However, it mentions that "application testing done on the cobas c701 and c502, using IgA as a representative assay," and that Sodium, Potassium, and Chloride were also tested.
The data provenance (country of origin, retrospective or prospective) is not specified. However, given that it's a submission to the FDA, the testing would likely have been conducted in a controlled, prospective manner to evaluate the new device's performance, potentially at Roche Diagnostics development sites or clinical study sites.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The type of ground truth used is clinical measurements from established methods (predicate device, flame photometry for Sodium/Potassium, coulometry for Chloride). The interpretation of "ground truth" in this context refers to the values obtained from these established reference methods, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the study involves analytical performance comparison rather than subjective assessment needing adjudication (like image interpretation). The "ground truth" is based on instrument readings from established methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device is a chemistry analyzer and its performance is assessed by analytical accuracy and precision, not by human reader interpretation of results.
6. Standalone (Algorithm Only) Performance
This entire submission describes the standalone performance of the instrument. The cobas 8000 Modular Analyzer Series is an automated system designed to run without human intervention during the analytical process, once samples and reagents are loaded. The results are generated by the algorithm/instrument directly.
7. Type of Ground Truth Used
The ground truth for the test set was established using recognized reference methods and performance of the predicate device:
- For IgA: Method comparison was performed against the cobas c501 (predicate device).
- For Sodium, Potassium: Method comparison was performed against the cobas c501 (predicate device) and flame photometry. Flame photometry is a well-established analytical technique for determining the concentration of certain metal ions.
- For Chloride: Method comparison was performed against the cobas c501 (predicate device) and coulometry. Coulometry is a precise electroanalytical technique used for quantitative determination of substances.
These are considered objective, analytical measurements from established laboratory techniques.
8. Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its sample size. This type of device (clinical chemistry analyzer) is typically developed and validated against established analytical principles and reference methods, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The "training" in this context would implicitly refer to the development and optimization process based on chemical and physical principles, rather than an explicit dataset.
9. How the Ground Truth for the Training Set was Established
As no explicit training set is mentioned in the context of machine learning, the concept of "ground truth for the training set" as it would apply to AI is not applicable. The development and "training" of this device would involve engineering, chemical, and physical principles, with performance validated against known standards, calibrators, and reference methods as described in point 7.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.