Who is the manufacturer of COBAS 8000 MODULAR SERIES ANALYZER?

Roche Diagnostics Corp. filed the 510(k) submission for COBAS 8000 MODULAR SERIES ANALYZER (K100853).

What is the FDA product code for COBAS 8000 MODULAR SERIES ANALYZER?

DCF. It is classified under 21 CFR 866.5040 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for COBAS 8000 MODULAR SERIES ANALYZER?

510(k) clearance (submission type: Special).

What are the predicate devices for COBAS 8000 MODULAR SERIES ANALYZER?

Roche cobas 6000 Analyzer Series (K060373).

Who can help prepare an FDA 510(k) submission like COBAS 8000 MODULAR SERIES ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COBAS 8000 MODULAR SERIES ANALYZER

K100853 · Roche Diagnostics Corp. · DCF · Sep 9, 2010 · Immunology

Device Facts

Record ID	K100853
Device Name	COBAS 8000 MODULAR SERIES ANALYZER
Applicant	Roche Diagnostics Corp.
Product Code	DCF · Immunology
Decision Date	Sep 9, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 866.5040
Device Class	Class 2

Intended 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.

Device Story

Fully automated clinical chemistry analyzer for high-throughput professional laboratory use. System utilizes ion-selective electrodes (ISE) and photometric analysis modules (c701, c502) to process serum, plasma, urine, CSF, and whole blood. Core unit manages sample conveyance via barcode-tracked racks; STAT port included. Data Manager PC acts as command/control center for LIS communication, result traceability, and calibration management. Healthcare providers use graphical user interface to monitor instrument status and review results. System automates reagent handling via RFID-identified cassettes. Output provides quantitative/qualitative analyte concentrations, aiding clinical diagnosis and treatment decisions. Benefits include increased throughput and standardized, automated workflow for clinical chemistry testing.

Clinical Evidence

Bench testing only. Performance evaluated using IgA as a representative assay and ISE modules for electrolytes. Testing included within-run and between-day precision, linearity, and recovery of controls. Method comparison performed against the predicate (c501) and reference methods (flame photometry for Na/K, coulometry for Cl). All results met pre-defined specifications.

Technological Characteristics

Modular clinical chemistry analyzer. Measurement principles: Absorbance Photometry and ISE Potentiometry. Reagent identification via RFID. Liquid level detection via electrostatic sensing. Connectivity: LIS integration via Data Manager. Software: cobas 8000 system software. Core unit includes barcode reader for sample/rack tracking.

Indications for Use

Indicated for in vitro qualitative and quantitative determination of analytes in body fluids (serum, plasma, urine, CSF, whole blood) in professional clinical environments. ISE module indicated for potentiometric determination of chloride, potassium, and sodium in serum and plasma for diagnosis/treatment of electrolyte imbalance. IgA test indicated for quantitative determination of IgA in human serum and plasma to aid diagnosis of abnormal protein metabolism and immune deficiency.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Roche cobas 6000 Analyzer Series (K060373)

Related Devices

K112412 — AU5800(R) CHEMISTRY ANALYZER · Beckman Coulter, Inc. · Dec 23, 2011
K965240 — SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L · Beckman Instruments, Inc. · Mar 10, 1997
K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM · Siemens Healthcare Diagnostics · Nov 22, 2011
K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEM · Bayer Corp. · May 21, 1999
K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) · Beckman Coulter, Inc. · Dec 18, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ # 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. | |--|---------------------------------------------------------------------------------------------------------------| |--|---------------------------------------------------------------------------------------------------------------| {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) {3}------------------------------------------------ | Table 1 | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Topic | cobas c501 analyzer module with ISE and cobas 6000 system software (current device) | cobas c701 and cobas 8000 ISE analyzer modules and cobas 8000 system software (modified device) | | | Basic features | | | Intended Use | Fully automated clinical chemistry analyzer intended for the in vitro quantitative/ qualitative determination of analytes in body fluids. | Same | | Measurement principle | • 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 without ISE | | Throughput, ISE Potentiometry | Max. 600 tests per hour | Max. 1800 tests per hour | | Reagent container (non-electrolytes) | Plastic bottles closed via pierceable screwcaps | Plastic bottles closed via screwcaps with modified cassette design and modified bottle material | | Reagent access | Cassette caps pierced onboard by the instrument | Cassette caps to be opened before placing on instrument | | Reagent bottle/Cassette identification | Barcode | RFID | | Pipetting System | | | | Liquid level detection reagent | Initial Cassette Volume Check (ICVC) | Electrostatic | | Electrolytes | Reagent transfer steps by pipetting using transfer arms | Reagent transfer steps partly by aspiration using tubes | | Software | cobas 6000 system software | cobas 8000 system software | | Core Unit functions | Real time database, data input and output (via HOST communication), control of sample conveyer | Real time database, data input and output (via Data Manager communication), control of sample conveyer | | Data storage | Real time database in Core unit (storage of System and Application parameters, Calibration Data ,QC Data, Sample results, Alarm history) | Real time database in Core unit and Data Manager (storage of System and Application parameters, Calibration Data ,QC Data, Sample results, Alarm history) | {4}------------------------------------------------ Table 2 | Topic | cobas c501 with ISE and cobas 6000 system software (current device) | cobas c502 analyzer module and cobas 8000 system software (modified device) | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Basic features | | | | Intended Use | Fully automated clinical chemistry analyzer intended for the in vitro quantitative/ qualitative determination of analytes in body fluids. | Same | | Measurement principle | 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 Unit functions | Real time database, data input and output (via HOST communication), control of sample conveyer | Real time database, data input and output (via Data Manager communication), control of sample conveyer | | Data storage | Real time database in Core unit (storage of System and Application parameters, Calibration Data ,QC Data, Sample results, Alarm history) | Real time database in Core unit and Data Manager (storage of System and Application parameters, Calibration Data ,QC Data, Sample results, 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ #### 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