(28 days)
Not Found
No
The document describes a standard automated clinical chemistry and immunoassay analyzer. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The system is described as "software-controlled" but this is a general term for automated systems and does not imply AI/ML.
No
This device is an in vitro diagnostic (IVD) system used for analyzing body fluids to diagnose and monitor various conditions. It does not directly treat or prevent diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "qualitative and quantitative in vitro determinations" and that "Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions." Specific examples include "diagnosis and treatment of pancreatitis," "diagnosis and treatment of numerous renal and metabolic disorders," and "diagnosis of immunologic disorders." These are all diagnostic purposes.
No
The device description explicitly lists multiple hardware units (Control unit, Core unit, c 501 module, c 601 module) and describes their physical components and functions. While it is software-controlled, it is fundamentally a hardware system for performing laboratory analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the cobas 6000 series and its components (cobas c501, cobas e601, ISE module, and various assays) are intended for "in vitro determinations" and "in vitro quantitative/qualitative determination of analytes in body fluids." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken 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 (serum, plasma, urine) using various analytical methods (photometric, immunoassay, ion-selective electrodes) to measure specific analytes. This is the core function of an IVD.
- Specific Assays: The descriptions of the individual assays (a-Amylase EPS ver.2, Uric Acid ver.2, Tina-quant Complement C3c ver.2, Acetaminophen, Opiates II) all state they are "in vitro tests" for the determination of specific substances in body fluids, and that the measurements are used for diagnosis and treatment.
The document consistently uses language and describes functions that are characteristic of in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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/ qualitative 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.
Product codes (comma separated list FDA assigned to the subject device)
CEM, CGZ, CZW, DJG, JFJ, JGS, KNK, LDP, JJE
Device Description
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.
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)
Not Found
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.
K953239 / A005, K961481 / A003
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
§ 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.
0
K 060373
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3723 | |
| Contact person: Kerwin Kaufman | |
| Date prepared: January 23, 2006 | |
| Device Name | Proprietary name: cobas 6000 Series system |
| Common names: Analyzer, Chemistry (Photometric,Discrete), for clinical use | |
| Classification names: Discrete photometric chemistry analyzer for clinical use | |
| Device Description | 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, andperforms 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 unitCore unit cu 150c 501 modulec 601 module | |
| Continued on next page |
:
1
Device The control unit uses a graphical user interface to control all instrument Description functions, and is comprised of a printer, TFT monitor, keyboard and mouse (continued) 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.
2
| Intended use /
Indications for
use | 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/ qualitative 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. |
| Predicate
Device | We claim substantial equivalence to the predicate devices, the Roche/Hitachi
MODULAR ANALYTICS System with MODULAR P and ISE Module,
cleared in K953239 / A005, and the Roche Elecsys MODULAR E170,
cleared in K961481 / A003. |
3
The table below compares the modified device, cobas 6000 Series System to Device the current device, Roche/Hitachi MODULAR ANALYTICS System. modification, cobas 6000 Series
| Topic | Roche/Hitachi MODULAR
ANALYTICS System with
MODULAR P and ISE
Module (K953239 / A005)
and MODULAR E170
(K961481 / A003) | cobas 6000 Series System
with
cobas c 501 and e 601
Analyzers
(Modified Device) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | System Description | |
| Intended Use | The MODULAR
ANALYTICS for the Serum
Work Area is a fully
automated system for
immunological,
potentiometric and
photometric analysis.
The Hitachi MODULAR P
is a fully automated, discrete
clinical chemistry analyzer
intended for the in vitro
quantitative / qualitative
determination of analytes in
body fluids.
The Roche Elecsys E170 is a
fully automated, discrete
immunoassay analyzer
intended for the in vitro
quantitative / qualitative
determination of analytes in
body fluids | 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/ qualitative
determination of analytes
in body fluids. |
4
Device modification, cobas 6000 Series (continued)
| Topic | Roche/Hitachi MODULAR ANALYTICS System with
MODULAR P and ISE Module (K953239 / A005) and MODULAR E170 (K961481 / A003) | cobas 6000 Series System with
cobas c 501 and e 601 Analyzers
(Modified Device) |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Description (continued) | | |
| Intended Use (continued) | | The cobas e601 analyzer is a fully automated discrete immunoassay analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. |
| Measurement principle | • ISE Potentiometry (electrolytes)
• Absorbance Photometry (enzymes, substrates, proteins, DAT, TDM)
• Electrochemiluminescence Immunoassay method | Same |
| Reaction modes | Endpoint, kinetic, potentiometric, electro-chemiluminescence | Same |
| Software SIMILARITIES | | |
| Software | MODULAR ANALYTICS System Software | cobas 6000 series System Software (modified MODULAR ANALYTICS software) |
| Configuration | Several analytical units with one PC and one core | Same |
| Topic | Roche/Hitachi MODULAR
ANALYTICS System with
MODULAR P and ISE
Module (K953239 / A005)
and MODULAR E170
(K961481 / A003) | cobas 6000 Series System
with
cobas c 501 and e 601
Analyzers
(Modified Device) |
| Software SIMILARITIES (continued) | | |
| Functions performed | Data input, sample
processing, result
calculation, result reporting,
quality control | Same |
| PC (Controller Unit)
functions | Data input (keyboard, disc),
data output (screen, printer) | Same |
| Core Unit functions | Real time database, data
input and output (via HOST
communication), control of
sample conveyer | Same |
| Analytical Unit(s)
functions | Control of analytic processes
(pipetting, incubation,
detection) | Same |
| Data storage | Primary Signal processing
Real time database in Core
unit (storage of System and
Application parameters,
Calibration Data ,QC Data,
Sample results, Alarm
history) | Same |
| Result calculation | Automated measuring of
signal for kinetic and
endpoint methods according
to cycle time and automated
calculation of concentrations
via calibration curve | Same |
| User management | Yes | Yes |
| Flagging of errors | Available | Available |
| Topic | Roche/Hitachi MODULAR
ANALYTICS System with
MODULAR P and ISE
Module (K953239 / A005)
and MODULAR E170
(K961481 / A003) | cobas 6000 Series System
with
cobas c 501 and e 601
Analyzers
(Modified Device) |
| Software DIFFERENCES | Software DIFFERENCES | |
| Units controlled | MODULAR P analyzer, ISE
analyzer, MODULAR D
analyzer, E170 analyzer | cobas c501 and cobas
e601 analyzers |
| HbA1c measurement on
cobas c501 | Hemolysate application as
separate assays | Hemolysate application as
one assay |
| Initial cassette volume
check (ICVC) for
reagent pipetting on
cobas c501 | Not available | Available |
| Clot detection | Not available on
MODULAR P but
available on E170 | Available on both cobas
c501 and e601 analyzers |
| Sample carry over
evasion from cobas
c501 module to the e601
module | One feature implemented to
prevent sample carry over
from MODULAR P to E170 | Additional feature
implemented to prevent
sample carry over |
| Data concept
(Application parameter,
calibrator, control value
transfer) for cobas c501
and e601 modules | No electronic transfer | Electronic transfer possible
(user must accept transfer
before parameters applied) |
| QC concept for cobas
c501 and e601 modules | Auto QC not available | Auto QC implemented |
5
510(k) Summary: Device Modification— Roche cobas 6000 Series System, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and the same of the same of the same of the same of the same of the same of the season of the season of the season of the season of the season
Device modification, cobas 6000 Series (continued)
Continued on next page
: :
6
Device modification, cobas 6000 Series (continued)
7
Device Modification, cobas c 501
The table below compares the similarities and differences of the cobas c 501 analyzer to the Hitachi MODULAR P analyzer.
| Topic | Hitachi MODULAR P
(K953239 / A005) | cobas c 501 Analyzer
(Modified Device) |
|------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Analyzer Features | | |
| Throughput | Max. 800 tests per hour
without ISE | Max. 600 tests per hour
without ISE |
| Analyzer size | Stand alone module or
multiple modules linked to
form one unit | Same |
| Sample Handling | | |
| Typical sample volumes | 2-35 µL | 1.0 - 35 µL |
| Sample types | Serum, plasma, urine, CSF
and other depending on the
chemistry test | Same |
| Sample handling system | Input of samples via core
input buffer using universal
sample racks | Same |
| Sample capacity on
board | 300 | 150 |
| Sample identification | Barcode | Same |
| Reagent Handling | | |
| Reagent volume | 20-270 µL | 5-180 µL |
| Reagent container
(electrolytes) | Plastic bottles closed via
screwcaps | Same |
| Reagent container (non-
electrolytes) | Plastic bottles closed via
screwcaps | Plastic bottles closed via
pierceable screwcaps with
modified bottle material |
| Reagent access | Manual opening of reagent
bottle prior to placement
onboard | Reagent cassette caps
pierced onboard by the
instrument |
| Onboard storage
temperature | Refrigerated 5-12 °C | Same |
8
cobas c 501 (continued)
| Topic | Hitachi MODULAR P
(K953239 / A005) | cobas c 501 Analyzer
(Modified Device) |
|---------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Bottle /
Cassette identification | Barcode | Same |
| On board reagent
storage capacity | 44 rotor channels on 2 rotors
to run 44 reagent kits in
parallel | 60 rotor channels on 1
rotor to run 60 reagent kits
in parallel |
| System cycle time | 18 sec | 8 sec |
| Reagent mixing | Stirring | Ultrasonic |
| Auto rerun | Available | Same |
| Pipetting System | XY robotic | Same |
| Sample and reagent
Syringes | XY robotic | Same |
| Reagent probes | 2 polished steel probes | 2 polished steel probes with
modified design |
| Sample probes | 1 polished steel probe | 1 polished steel probe with
modified design |
| Probe cleaning | Automatic for all probes | Same |
| Liquid level detection | Electrostatic for sample and
reagents | Electrostatic for sample |
| | | Initial Cassette Volume
Check (ICVC) and bubble
detection for reagent |
| Clot detection | Not available | Provided |
| Test Reaction Chamber | Circulating water bath at
37°C. | Same |
| Temperature control | Circulating water bath at
37°C. | Same |
| Cuvettes | Multiple use | Same |
| Topic | Hitachi MODULAR P
(K953239 / A005) | cobas c 501 Analyzer
(Modified Device) |
| | ISE Module | |
| ISE module | Separate ISE Module
(K953239 / A005) integrated
into MODULAR
ANALYTICS System | Module integrated into
cobas c 501 analyzer; new
hardware design with
modified pipetting scheme
for sample and reagent |
| Ion selective electrodes
(ISES) | Potentiometric chloride,
potassium, sodium and
reference electrodes | Same |
| ISE throughput | Up to 900 tests/hour | Up to 600 tests/hour |
| | Detection Information | |
| Spectrophotometer | Gradient photometer with
discrete photodiodes in fixed
array | Same |
| Light source | Tungsten/halogen | Same |
| Light path | 0.50 cm | 0.56 cm |
| Measuring unit | 1 | Same |
| Wavelengths | 340, 376, 415, 450, 480,
505, 546, 570, 600, 660,
700, 800 nm | Same |
| | Calibration and quality control | |
| Calibrators | Multiple use | Same |
| Calibration modes | Linear, nonlinear | Same |
| Calibration / on board stability | Typically each lot or 4
weeks for same reagent on
board | Typically each lot or 12
weeks for same reagent on
board |
| Control storage on instrument | No | In analyzer remote buffer
area at ambient
temperature |
| Calibrator / control value transfer | Via Barcode Transfer Sheet,
application disk or manual
entry | Via remote transfer or
CD-ROM |
| Internal quality management system | Available to monitor and
validate test results | Same |
Continued on next page
9
10
510(k) Summary: Device Modification--- Roche cobas 6000 Series System, Continued の 【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【
cobas c 501 (continued)
| Interfaces | ||
|---|---|---|
| Host Interface | RS232C bi-directional | Same |
| Printer | Dot matrix | Laser |
| Display | Keyboard + touch-screen | Same |
| Optional use of mouse |
.
The table below compares the cobas e 601 analyzer to the Elecsys Device Modification, MODULAR E170 analyzer. cobas e 601
| Topic | Elecsys MODULAR E170
(K961481 / A003) | cobas e 601 Analyzer
(Modified Device) |
|---------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Features | | |
| Intended Use | Intended to be used for the in
vitro quantitative and
qualitative analysis 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. |
| Indication for use | For professional use only | Same |
| Operating principle | Electrochemiluminescence
Immunoassay method | Same |
| Workflow principle | Random access or batch | Same |
| Analyzer size | Floor analyzer | Same |
| Maximum Throughput | 170 tests/hour per module | Same |
の 2007年07月20日 17:47 17:00 PM 17:00 PM 17:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM
11
cobas e 601 (continued)
and the comments of the comments of the comments of the comments of the contribution of the contribution of the first and the first and the first and the first of the first o
| Topic | Elecsys MODULAR E170
(K961481 / A003) | cobas e 601 Analyzer
(Modified Device) |
|--------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Configuration | 1 stand alone module or 2-4
modules linked together in
Roche MODULAR
Analytics System | 1 stand alone module or up
to 2 modules linked
together in the cobas 6000
Series System |
| Sample | | |
| Sample material | Serum and Plasma | Same |
| Sample input | Via sample racks | Same |
| Positive Identification | Yes | Same |
| Reagents | | |
| Reagent Kits | Assay RackPack | Same |
| No. of Channels | 25 | Same |
| On-board Temperature | 18-22°C | Same |
| System reagents | ProCell, CleanCell,
SysClean, PreClean, *
ProbeWash*
- used for specific assays | Same |
| Sample Pipetting | | |
| Liquid level detection | Electrostatic sensing | Same |
| Clot detection | Yes | Same |
| Pipetting device | Disposable tip | Same |
| Reagent Pipetting | | |
| Pipetting device | Steel probe | Same |
| Incubation | | |
| Temperature | 37°C | Same |
| Timing | 18 minutes * - specific assays: 17 minutes | Same |
| Detection | | |
| Device | ECL unit
(sipper, cell, PMT) | Same |
| Channels | 2 | Same |
Continued on next page
: 上海
12
510(k) Summary: Device Modification— Roche cobas 6000 Series System, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
cobas e 601 (continued)
| Topic | Elecsys MODULAR E170
(K961481 / A003) | cobas e 601 Analyzer
(Modified Device) |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Calibration / Quality Control | | |
| Calibration mode | 2-point calibration | Same |
| Calibrators and Controls | CalSets, CalChecks and
Controls | Same |
| Calibration intervals
with each new lot | Mandatory | Same |
| Calibration stability | 4 weeks | Same |
| Dilution | | |
| On-board | Optional | Same |
| Disposables | | |
| Tips | | Same |
| Assay cups | | Same |
| Failsafe | | |
| Failsafe Concept | Internal Quality
Management System on
multiple levels:
-Control and verification of
instrument operation
-Data input control
-Validation of results
-Corresponding Alarm and
Flag System | Same |
.
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming a wing-like shape above a staff with intertwined snakes. The overall design is simple and recognizable, representing the department's role in public health and human services.
Public Health Service
MAR 1 3 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kerwin Kaufman, MBA, MT(ASCP) Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K060373
Trade/Device Name: cobas 6000 Series System Regulation Number: 21 CFR§862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, CGZ, CZW, DJG, JFJ, JGS, KNK, LDP, JJE Dated: February 10, 2006 Received: February 13, 2006.
Dear Mr. Kaufman;
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 either class II (Special Controls) or class III (PMA), 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 af 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
14
Page 2 -
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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
15
Indications for Use
510(k) Number (if known): K060373
Device Name: cobas 6000 Series System
Indications For Use:
The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitiative in vitro determinations using a wide variety of tests. It is optimized for high throughout 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.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offiee of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device
Evaluation and Safety
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Indications for Use
510(k) Number (if known): K060373
Device Name: cobas 6000 Series System
Indications For Use: (CONTINUED)
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.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) | |
|---|---|
| Division Sign-Off | Page 2 of 2 |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
060373