(28 days)
The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE), a photometric analysis unit and an immunoassay analysis module.
The cobas c501 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative determination of analytes in body fluids.
The cobas e601 analyzer is a fully automated discrete immunoassay analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The a-Amylase EPS ver.2 assay is an in vitro test for the quantitative determination of a-Amylase in serum, plasma and urine on Roche/Hitachi cobas c systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis.
The Uric Acid ver.2 assay is an in vitro test for the quantitative determination of uric acid in human serum, plasma and urine on Roche/Hitachi cobas c systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Tina-quant Complement C3c ver.2 assay is an in vitro test for the quantitative determination of Complement C3c in human serum and plasma on Roche/Hitachi cobas c systems. Measurement of complement C3c aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
The ISE module of the Roche/Hitachi cobas c systems is intended for the quantitative determination of sodium, potassium and chloride in serum, plasma or urine using ionselective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
The Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche/Hitachi cobas c systems. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The Opiates II assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of morphine and its metabolites in human urine on Roche/Hitachi cobas c systems at cutoff concentrations of 300 and 2000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Opiates II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose.
The cobas 6000 Series system: is fully automated, is modular, is computerized, uses serum/plasma, urine, CSF, and supernatant sample types, performs in vitro quantitative and qualitative tests on a wide range of analytes, and performs photometric assays and ion-selective electrode measurements on a c 501 module as well as electrochemi- luminescence (ECL) assays on an e 601 module.
The cobas 6000 system comprises the following hardware units, which can be combined in various combinations: Control unit, Core unit cu 150, c 501 module, c 601 module.
The control unit uses a graphical user interface to control all instrument functions, and is comprised of a printer, TFT monitor, keyboard and mouse and a personal computer using the Windows XP operating system. 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. The core unit comprises at least the sampling unit and one rack rotor as main components. Conveyor line(s) and a second rack rotor are possible extensions. Several other core unit components include the sample rack loader/unloader, a STAT port, a barcode reader (for racks and samples), a water supply and a system interface port. The c 501 module comprises a photometric unit and an ISE unit (for ionselective electrode determinations). The photometric unit assays up to 600 in vitro tests per hour on a wide range of analytes. The main components of the c 501 module are a sampling system, a reagent system and a reaction disk system. The c 501 module also contains an integrated ISE unit, providing a potentiometric method for assaying sodium, potassium and chloride samples, processing up to 200 samples (600 tests) per hour. The e 601 module is analytically identical to the Elecsys E170 MODULAR ANALYTICS immunoassay analyzer, which was cleared in a letter to file K961481 / A003. Hardware changes are only cosmetic (shape, color) or housing related (sample rack interface), and do not impact analytical properties or performance of the analyzer. The e 601 module is a muti-test immunoassay system with random access and with a capacity of up to 170 tests per hour. The main components of the e 601 module are a reagent area, a measurement area, a consumables area and a PreClean area.
Here's an analysis of the provided text regarding the cobas 6000 Series system, focusing on acceptance criteria and study details.
Based solely on the provided text, this submission (K060373) is a 510(k) premarket notification for a new version of an existing device (cobas 6000 Series System) that claims substantial equivalence to previously cleared predicate devices (Roche/Hitachi MODULAR ANALYTICS System with MODULAR P and ISE Module K953239 / A005, and Roche Elecsys MODULAR E170 K961481 / A003).
The documentation primarily focuses on comparing the new device to its predicates, highlighting similarities and differences in hardware, software, and intended use. It does not contain detailed information about specific acceptance criteria, performance studies (other than implicitly relying on the predicate device's performance), sample sizes for test or training sets, ground truth establishment, or expert involvement for this specific 510(k) submission.
The purpose of this 510(k) summary is to demonstrate that the new device is "substantially equivalent" to already legally marketed devices, not to re-prove its fundamental performance from scratch. Therefore, it leverages the previous clearances.
However, I can extract and infer information where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Generally, for this type of device (clinical chemistry and immunoassay analyzer), performance is measured against established analytical performance metrics. Since this is a 510(k) demonstrating substantial equivalence to predicate devices, the "acceptance criteria" and "reported device performance" are implicitly aligned with those already established for the predicate devices. The document does not explicitly state numerical acceptance criteria or new performance data for all aspects of the device.
The document does mention in the "Device Description" and "Intended Use" sections that the system "performs in vitro quantitative and qualitative tests on a wide range of analytes" and is "optimized for high throughput workloads." The performance characteristics (e.g., accuracy, precision, linearity, limits of detection) of assays run on this system would be specific to each assay, not the analyzer itself.
However, specific comparative details are given for physical and functional parameters, which serve as acceptance criteria for "substantial equivalence" rather than clinical performance.
| Topic | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (cobas 6000 Series System) |
|---|---|---|
| General | Fully automated, random-access, software-controlled system for immunoassay and photometric analysis for qualitative and quantitative in vitro determinations. Optimized for high throughput with ISE, photometric, and immunoassay modules. | Same |
| Measurement Principle | • ISE Potentiometry | |
| • Absorbance Photometry | ||
| • Electrochemiluminescence Immunoassay method | Same | |
| Reaction modes | Endpoint, kinetic, potentiometric, electro-chemiluminescence | Same |
| Software | MODULAR ANALYTICS System Software, configured with several analytical units, one PC, one core. Functions: Data input, sample processing, result calculation, reporting, QC. PC functions: data input/output. Core Unit: real-time database, I/O via HOST, control of sample conveyer. Analytical Units: control of analytic processes. Data storage: Primary Signal processing, real time database in Core unit. Result calculation: Automated measuring, calculation via calibration curve. User management, Flagging of errors available. | cobas 6000 series System Software (modified MODULAR ANALYTICS software). Configuration, Functions, PC functions, Core Unit functions, Analytical Unit functions, Data storage, Result calculation, User management, Flagging of errors are all Same as predicate. |
| cobas c 501 (Photometric Module) | ||
| Throughput | Max. 800 tests per hour (without ISE) | Max. 600 tests per hour (without ISE) - DIFFERENCE |
| Analyzer size | Stand alone module or multiple modules linked | Same |
| Sample volumes | 2-35 µL | 1.0 - 35 µL - DIFFERENCE |
| Sample capacity | 300 | 150 - DIFFERENCE |
| Reagent volume | 20-270 µL | 5-180 µL - DIFFERENCE |
| Reagent containers | Plastic bottles closed via screwcaps | Plastic bottles closed via pierceable screwcaps with modified bottle material - DIFFERENCE |
| Reagent access | Manual opening of reagent bottle | Reagent cassette caps pierced onboard by the instrument - DIFFERENCE |
| On board reagent storage capacity | 44 rotor channels on 2 rotors (44 kits) | 60 rotor channels on 1 rotor (60 kits) - DIFFERENCE |
| System cycle time | 18 sec | 8 sec - DIFFERENCE |
| Reagent mixing | Stirring | Ultrasonic - DIFFERENCE |
| Reagent probes | 2 polished steel probes | 2 polished steel probes with modified design - DIFFERENCE |
| Sample probes | 1 polished steel probe | 1 polished steel probe with modified design - DIFFERENCE -------------------------------------------------------------------------- |
| Liquid level detection (reagents) | Electrostatic for reagents | Initial Cassette Volume Check (ICVC) and bubble detection for reagent - DIFFERENCE |
| Clot detection | Not available | Provided - DIFFERENCE |
| Light path | 0.50 cm | 0.56 cm - DIFFERENCE |
| ISE module | Separate ISE Module integrated into MODULAR ANALYTICS System. ISE throughput: Up to 900 tests/hour. | Module integrated into cobas c 501 analyzer; new hardware design with modified pipetting scheme for sample and reagent. ISE throughput: Up to 600 tests/hour - DIFFERENCE |
| Calibration stability | Typically each lot or 4 weeks | Typically each lot or 12 weeks - DIFFERENCE |
| Control storage | No | In analyzer remote buffer area at ambient temperature - DIFFERENCE |
| Calibrator/control value transfer | Via Barcode Transfer Sheet, application disk or manual entry | Via remote transfer or CD-ROM - DIFFERENCE |
| Printer | Dot matrix | Laser - DIFFERENCE |
| cobas e 601 (Immunoassay Module) | ||
| Configuration | 1 stand-alone module or 2-4 modules linked in Rochester MODULAR Analytics System | 1 stand-alone module or up to 2 modules linked together in the cobas 6000 Series System - DIFFERENCE |
Note: The phrase "Same" indicates that the new device characteristic is identical to the predicate, implying it meets the substantial equivalence criteria. "Difference" indicates a change, which then needs to be justified as not altering the intended use or fundamental scientific technology, or raising new safety/effectiveness questions that would preclude substantial equivalence. The document doesn't provide numerical acceptance values for these differences, but the FDA's clearance implies these differences were acceptable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not contain any information regarding sample sizes for test sets, data provenance (country of origin), or whether studies were retrospective or prospective for this specific 510(k) submission. Given it is a substantial equivalence submission for an analyzer system, the focus is on the comparison with predicate devices and any new functionalities or changes, rather than a de novo clinical validation of every assay.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not contain any information about the number or qualifications of experts used to establish ground truth for testing the device system itself. Ground truth, in the context of IVD analyzers, is typically established by comparing results from the test device to a reference method or a legally marketed device using patient samples or control materials. This level of detail is not typically included in a 510(k) summary focused on substantial equivalence to a predicate system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not contain any information about an adjudication method. This concept is more relevant to studies where human interpretation of data (e.g., medical imaging) is being assessed, rather than an automated clinical chemistry or immunoassay analyzer.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The provided text does not contain any information about an MRMC comparative effectiveness study. This type of study and the concept of "human readers improving with AI assistance" are completely irrelevant to an automated clinical chemistry and immunoassay analyzer like the cobas 6000 Series system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire cobas 6000 Series system is an automated, standalone device for performing in vitro diagnostic tests. Its performance is inherently "algorithm only" in terms of the analytical processes and result generation. Human interaction is for setup, programming, maintenance, and interpretation of the results it produces, not for real-time intervention in the analytical process the device performs. The documentation describes it as "fully automated," which is precisely standalone performance for its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For clinical chemistry and immunoassay analyzers, ground truth for performance studies (e.g., accuracy, precision) typically relies on:
- Reference methods: Highly accurate and precise analytical techniques.
- Certified reference materials: Materials with known analyte concentrations.
- Comparative methods: Testing samples on another legally marketed, well-established device.
- Clinical correlation: (Less common for the analyzer itself, more for specific assays' clinical utility) comparing results to actual patient diagnosis or outcome where the assay is indicated.
Since this is a substantial equivalence submission, it relies heavily on the predicate device's established performance, implying that its ground truth was established by methods similar to those above for each individual assay.
8. The sample size for the training set
The provided text does not contain any information about a "training set" or its sample size. This concept is most applicable to machine learning or AI algorithms where a model is trained on data to learn patterns. While the device contains "software" and performs "result calculation via calibration curve," it's not described as an AI/ML device in the sense that would require a distinct "training set" for an AI algorithm's development as per modern definitions. Its performance parameters are likely validated through traditional analytical studies.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML algorithm, the provided text does not contain any information on how ground truth for a training set was established.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.