AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

Not Found

No
The description focuses on automated clinical chemistry analysis using standard laboratory techniques (ISE and photometry) and data management. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.

No
Explanation: The device is intended for in vitro qualitative and quantitative determination of analytes in body fluids, aiding in diagnosis and treatment monitoring, but it does not directly provide therapy.

Yes
The device is described as being used for the "in vitro qualitative and quantitative determination of analytes in body fluids" and that "Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance." This directly indicates its role in diagnosis.

No

The device description clearly outlines multiple hardware components including analyzers, modules, a core unit with a barcode reader, and a control unit with a touch screen monitor, keyboard, mouse, and PC. While software is mentioned (Data Manager, graphical user interface), it is integral to the operation of the physical hardware system.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states the system is "intended for the in vitro qualitative and quantitative determination of analytes in body fluids." It also mentions specific analytes like IgA, chloride, potassium, and sodium, and how their measurements are used in the "diagnosis and treatment of diseases or conditions." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
  • Device Description: The description details a system designed to analyze body fluids using various methods (ISE and photometric analysis). This is consistent with the function of an IVD.
  • Specific Modules: The descriptions of the cobas c701, cobas c502, and cobas 8000 ISE module all reiterate their intended use for "in vitro quantitative / qualitative determination of analytes in body fluids" or "in vitro potentiometric determination."
  • Reagent Mention: The mention of using the system "in conjunction with certain materials to measure a variety of analytes depending on the reagents used" further supports its role as an IVD, as IVDs typically rely on specific reagents to perform their tests.
  • Performance Studies: The description of performance studies involving precision, linearity, recovery, and method comparison for specific analytes (IgA, Sodium, Potassium, Chloride) are typical evaluations performed on IVD devices to demonstrate their analytical performance.
  • Predicate Device: The mention of a predicate device (K060373; Roche cobas 6000 Analyzer Series) which is also a clinical chemistry analyzer, strongly suggests that this device falls into the same regulatory category, which is IVD.

In summary, the language used throughout the document, the described function of the device, and the context of its use in a professional healthcare environment for analyzing body fluids for diagnostic purposes all clearly indicate that the cobas 8000 Modular Analyzer Series is an In Vitro Diagnostic device.

N/A

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.

Product codes (comma separated list FDA assigned to the subject device)

JJE, JGS, CEM, CGZ, CZP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060373

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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.
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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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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)

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Table 1
Topiccobas 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 UseFully 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,
PhotometryMax. 600 tests per hour without ISEMax. 2000 tests per hour without
ISE
Throughput, ISE
PotentiometryMax. 600 tests per hourMax. 1800 tests per hour
Reagent container
(non-electrolytes)Plastic bottles closed via pierceable
screwcapsPlastic bottles closed via screwcaps
with modified cassette design and
modified bottle material
Reagent accessCassette caps pierced onboard by the
instrumentCassette caps to be opened before
placing on instrument
Reagent
bottle/Cassette
identificationBarcodeRFID
Pipetting System
Liquid level
detection reagentInitial Cassette Volume Check
(ICVC)Electrostatic
ElectrolytesReagent transfer steps by pipetting
using transfer armsReagent transfer steps partly by
aspiration using tubes
Softwarecobas 6000 system softwarecobas 8000 system software
Core Unit
functionsReal time database, data input and
output (via HOST communication),
control of sample conveyerReal time database, data input and
output (via Data Manager
communication), control of sample
conveyer
Data storageReal 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)

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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.

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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