(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.
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K100853
510(k) Summary: Roche cobas 8000 Modular Analyzer Series
Introduction
| The information in this 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92. | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------- |
Submitter name, address, contact
| Roche Diagnostics | |
|---|---|
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| SEP 09 2010 | |
| Contact person: Angelo Pereira | |
| Phone: 317-521-3544 | |
| Fax: 317-521-2324 | |
| Email : angelo.pereira@roche.com | |
| Date prepared: August 19, 2010 |
Device Name
| Proprietary name: cobas 8000 Modular Analyzer Series | |
|---|---|
| Common names: Analyzer, Chemistry (Photometric,Discrete), for clinical use | |
| Classification names: Discrete photometric chemistry analyzer for clinical use | |
| (21 CFR 862.2160). Product code JJE | |
| Proprietary name: ISE Indirect Na, K, Cl for Gen.2 | |
| Regulation Number: 21 CFR 862.1665, Sodium test system | |
| Product Code: JGS | |
| Regulation Number: 21CFR 862.1600, Potassium test system | |
| Product Code: CEM | |
| Regulation Number: 21CFR 862.1170 Chloride test system | |
| Product Code: CGZ | |
| Proprietary name: Tina-quant IgA Gen.2 | |
| Regulation Number: 21 CFR 866.5510, IgA, Antigen | |
| Product Code: CZP |
Predicate Device
| We claim substantial equivalence to the Roche cobas 6000 Analyzer Series predicate device cleared in K060373. | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------------------- |
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Device The cobas 8000 Modular Analyzer Series is a fully automated system for Description 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.
Continued on next page
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510(k) Summary: Roche cobas 8000 Modular Analyzer
Series, Continued
Intended use / Indications for use
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. This device is intended for use in conjunction with certain materials to measure a variety of analytes that may be 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.
Device modifications
The tables below compare the modified device (cobas c 701, cobas c502 and cobas 8000 ISE analyzers with cobas 8000 system software) to the current device (cobas c 501 with cobas 6000 system software)
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| Table 1 | ||
|---|---|---|
| Topic | cobas c501 analyzer module withISE and cobas 6000 systemsoftware (current device) | cobas c701 and cobas 8000 ISEanalyzer modules and cobas 8000system software (modified device) |
| Basic features | ||
| Intended Use | Fully automated clinical chemistryanalyzer intended for the in vitroquantitative/ qualitativedetermination of analytes in bodyfluids. | Same |
| Measurementprinciple | • Absorbance Photometry (enzymes,substrates, proteins, DAT, TDM)• ISE Potentiometry (electrolytes) | Same |
| Throughput,Photometry | Max. 600 tests per hour without ISE | Max. 2000 tests per hour withoutISE |
| Throughput, ISEPotentiometry | Max. 600 tests per hour | Max. 1800 tests per hour |
| Reagent container(non-electrolytes) | Plastic bottles closed via pierceablescrewcaps | Plastic bottles closed via screwcapswith modified cassette design andmodified bottle material |
| Reagent access | Cassette caps pierced onboard by theinstrument | Cassette caps to be opened beforeplacing on instrument |
| Reagentbottle/Cassetteidentification | Barcode | RFID |
| Pipetting System | ||
| Liquid leveldetection reagent | Initial Cassette Volume Check(ICVC) | Electrostatic |
| Electrolytes | Reagent transfer steps by pipettingusing transfer arms | Reagent transfer steps partly byaspiration using tubes |
| Software | cobas 6000 system software | cobas 8000 system software |
| Core Unitfunctions | Real time database, data input andoutput (via HOST communication),control of sample conveyer | Real time database, data input andoutput (via Data Managercommunication), control of sampleconveyer |
| Data storage | Real time database in Core unit(storage of System and Applicationparameters, Calibration Data ,QCData, Sample results, Alarm history) | Real time database in Core unit andData Manager (storage of Systemand Application parameters,Calibration Data ,QC Data, Sampleresults, Alarm history) |
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Table 2
| Topic | cobas c501 with ISE and cobas6000 system software (currentdevice) | cobas c502 analyzer module andcobas 8000 system software(modified device) |
|---|---|---|
| Basic features | ||
| Intended Use | Fully automated clinical chemistryanalyzer intended for the in vitroquantitative/ qualitativedetermination of analytes in bodyfluids. | Same |
| Measurementprinciple | Absorbance Photometry (enzymes,substrates, proteins, DAT, TDM) ISE Potentiometry (electrolytes) | Same No ISE module |
| Software | ||
| Software | cobas 6000 system software | cobas 8000 system software |
| Core Unitfunctions | Real time database, data input andoutput (via HOST communication),control of sample conveyer | Real time database, data input andoutput (via Data Managercommunication), control of sampleconveyer |
| Data storage | Real time database in Core unit(storage of System and Applicationparameters, Calibration Data ,QCData, Sample results, Alarm history) | Real time database in Core unit andData Manager (storage of Systemand Application parameters,Calibration Data ,QC Data, Sampleresults, Alarm history) |
Reagent Applications: Risk analysis for application of reagents to the cobas 8000 system was conducted by Roche Diagnostics according to internal SOPs.
Based on the risk analysis, application testing done on the cobas c701 and c502, using IgA as a representative assay, included with-in run and between-day precision, linearity, recovery of controls and method comparison to the c501. Sodium, Potassium and Chloride were also tested on the ISE module. Testing included with-in run and betweenday precision, linearity, recovery of controls and method comparison to the c501 as well as to flame for sodium and potassium and coulometry for chloride. All testing met specifications.
Conclusion: The cobas 8000 Modular Analyzer Series is substantially equivalent to the predicate cobas 6000 analyzer series in design, modes of operation, assay performance and intended use.
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Image /page/5/Picture/0 description: The image shows a logo with an eagle and text surrounding it. The eagle is stylized with thick, black lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" and is arranged in a circular fashion around the eagle. The logo appears to be a seal or emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Roche Diagnostics c/o Mr. Angelo Pereira Regulatory Affairs Principle 9115 Hague Rd Indianapolis IN 46250
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K100853
Trade/Device Name: cobas 8000 Modular Analyzer Series Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, JGS, CGZ, CZP, JJE Dated: August 20, 2010 Received: August 23, 2010
SEP 0 9 2010
Dear Mr. Pereira:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100853
100853 EP 0 9 2010
Device Name: cobas 8000 Modular Analyzer Series
Indications For Use:
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.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100853
§ 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.