(383 days)
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+, K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option.
The cobas b 123 POC system consists of a modular analyzer incorporating a Linux-based graphical user interface with a large color touch screen interfacing the analyzer electronic, sensor, fluidic and AutoQC modules. The user interface module contains the analyzer CPU and all required electronic interfaces for external communication, data storage and data transfer. A single electrochemical sensor system independent of the reagent delivery system that utilizes Roche thick film technology consolidates the following analytes: pCO2, pH, calcium, potassium and sodium (potentiometric measurement); pO2 (amperometric measurement); Hct (conductivity measurement); Glucose and Lactate enzyme reaction (amperometric measurement). An optionally integrated oximeter module consisting of a spectrometer, measurement and calibration light source, respectively, an ultrasonic hemolyzer and thermostatic components measure SO2, tHb, O2Hb, HHb, COHb, and MetHb. A disposable, self-contained sample and reagent delivery system contains: Liquid reagents, calibrators and waste container, stable for 42 days on-board; Built-in safety shielded sample port; Built-in oximeter cuvette; Two peristaltic pump fluidics system; Built-in air filter. The system also includes an optional integrated AutoQC module which utilizes a disposable cassette containing three levels of quality control material. A smart memory chip is incorporated into each biosensor, reagent pack (sample and reagent delivery system) and AutoQC cassette providing the lot number, expiration date and value assignments (for QC and CVC materials). The chip also tracks and monitors sensor, reagent pack, AutoQC and AutoCVC cassette usage.
This is a 510(k) Summary for a medical device and therefore does not contain details about acceptance criteria, study methodologies, or performance against specific metrics as these are typically found in the full 510(k) submission. Acceptance criteria and detailed study information are usually proprietary data submitted to the FDA and are not part of the publicly available 510(k) Summary.
This document focuses on establishing substantial equivalence by comparing the cobas b 123 POC System and its associated control packs to previously cleared predicate devices. It lists the intended use, device descriptions, and similarities and differences between the new device and the predicate devices for various analytes.
Therefore, the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, training set sample size, and ground truth establishment) cannot be extracted from the provided text.
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cobas® b 123 POC System Section III: 510(k) Summary
Section III: 510(k) Summary
1111 88
510(k) Summary
MAY 1 4 2012
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.
and the contraction of the comments of the consisted on the contribution of the contribution of the contribution of the contribution of the contribution of the contribution o
Submitter name, address, contact
Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250
Contact Person: Sarah Baumann Phone: 317-521-3952 Fax: 317-521-2324 Email: sarah.baumann@roche.com
Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com
Date Prepared: May 14, 2012
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| Device name | Proprietary Name: | (1) cobas® b 123 POC System(2) cobas® b 123 AutoQC Pack Tri-Level(3) cobas® b 123 AutoCVC Pack(4) Roche COMBITROL PLUS B |
|---|---|---|
| Common Name: | (1) Blood gas analyzer(2) AutoQC Pack Tri-Level(3) AutoCVC Pack(4) COMBITROL PLUS B |
. '
| Analyte | Classification Name | Regulation Section | ProductCode |
|---|---|---|---|
| PCO2, PO2, pH | Blood gases (PCO2, PO2) and bloodpH test system | 21 CFR § 862.1120 | CHL |
| Na+ (sodium) | Sodium test system | 21 CFR § 862.1665 | JGS |
| K+ (potassium) | Potassium test system | 21 CFR § 862.1600 | CEM |
| Ca2+ (Calcium) | Calcium test system | 21 CFR § 862.1145 | JFP |
| Hct (Hematocrit) | Automated hematocrit instrument | 21 CFR § 864.5600 | GKF |
| Glucose | Glucose test system | 21 CFR § 862.1345 | CGA |
| Lactate | Lactic acid test system | 21 CFR § 862.1450 | KHP |
| tHb | Whole blood hemoglobin assays(tHb) | 21 CFR § 864.7500 | KHG |
| O2Hb | Whole blood hemoglobin assays(Oxyhemoglobin) | 21 CFR § 864.7500 | GGZ |
| HHb | Deoxyhemoglobin | 21 CFR § 864.7500 | GKA |
| MetHb | Methemoglobin | 21 CFR § 864.5620 | KHG |
| SO2 | Oxygen Saturation | 870.1230 Oximeter | GLY |
| COHb (carboxyhemoglobin) | Carboxyhemoglobin assay | 21 CFR § 864.7425 | GHS |
| cobas b 123 AutoQC PackTri-Level | Quality control material(assayed and unassayed) | 21 CFR § 862.1660 | JJY |
| cobas b 123 AutoCVC Pack | |||
| Roche COMBITROL PLUS B |
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Confidential
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.
:
·
510(k) Summary, Continued
| Device description | (1) cobas b 123 POC System: |
|---|---|
| The cobas b 123 POC system consists of a modular analyzer incorporating a Linux-based graphical user interface with a large color touch screen interfacing the analyzer electronic, sensor, fluidic and AutoQC modules. The user interface module contains the analyzer CPU and all required electronic interfaces for external communication, data storage and data transfer. | |
| A single electrochemical sensor system independent of the reagent delivery system that utilizes Roche thick film technology consolidates the following analytes: | |
| pCO2, pH, calcium, potassium and sodium (potentiometric measurement)pO2 (amperometric measurement)Hct (conductivity measurement)Glucose and Lactate enzyme reaction (amperometric measurement) | |
| An optionally integrated oximeter module consisting of a spectrometer, measurement and calibration light source, respectively, an ultrasonic hemolyzer and thermostatic components measure SO2, tHb, O2Hb, HHb, COHb, and MetHb. | |
| A disposable, self-contained sample and reagent delivery system contains: | |
| Liquid reagents, calibrators and waste container, stable for 42 days on-boardBuilt-in safety shielded sample portBuilt-in oximeter cuvetteTwo peristaltic pump fluidics systemBuilt-in air filter | |
| The system also includes an optional integrated AutoQC module which utilizes a disposable cassette containing three levels of quality control material. | |
| A smart memory chip is incorporated into each biosensor, reagent pack (sample and reagent delivery system) and AutoQC cassette providing the lot number, expiration date and value assignments (for QC and CVC materials). The chip also tracks and monitors sensor, reagent pack, AutoQC and AutoCVC cassette usage. | |
| Continued on next page | |
| Confidential | Page 3 of 21 |
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(assayed and unassayed) (continued)
(2) cobas b 123 AutoQC Pack Tri-Level:
The cobas b 123 AutoQC pack Tri-Level contains 24 single glass ampoules of multi-analyte controls in 3 levels:
Level 1: representing concentrations of a patient's respiratory acidosis as given by low pH and high PCO2 values, low PO2, low values for Na", K*, and tHb, normal values for glucose and high values for Hct,
iCa** and lactate.
Level 2: representing concentrations of normal values for all parameters except glucose, which is low.
Level 3: representing concentrations of a patient's respiratory alkalosis as given by high pH and low PCO2 values, high PO2, high values for Na , K , tHb, and glucose, and low values for Hct, iCa + and lactate.
(3) cobas® b 123 AutoCVC Pack:
The cobas b 123 AutoCVC pack contains 24 single glass ampoules of multi-analyte controls in 6-levels covering the range of instrument performance. The CVC materials are an aqueous-based solution of salts, organic and carbonate buffers and metabolites equilibrated with predetermined levels of oxygen, carbon dioxide, nitrogen and dyes.
(4) Roche COMBITROL PLUS B:
COMBITROL PLUS B multi-analyte controls are available in 3 levels:
Level 1: representing concentrations of a patient's respiratory acidosis as given by low pH and high PCO2 values, low PO2, low values for Na , K , and tHb, normal values for glucose and high values for Hct,
iCa2+, urea/BUN and lactate.
Level 2: representing concentrations of normal values for all parameters except glucose, which is low.
Level 3: representing concentrations of a patient's respiratory alkalosis as given by high pH and low PCO2 values, high PO2, high values for Na *, K , tHb, and glucose, and low values for Hct, iCa -, lactate and urea/BUN.
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(1) cobas b 123 POC System: Intended use
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na *, K *, iCa2+ (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters.
It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option.
Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials (Table 1):
| Instrument Version | Measured Parameters | Optional Modules |
|---|---|---|
| cobas b 123 <1> System | pH, BG (pO2, pCO2), ISE (Na+, K+,Ca2+), Hct, Glu, Lac | N/A |
| cobas b 123 <2> System | pH, BG (pO2, pCO2), ISE (Na+, K+,Ca2+), Hct, Glu, Lac | AutoQC Module |
| cobas b 123 <3> System | pH, BG (pO2, pCO2), ISE (Na+, K+,Ca2+), Hct, Glu, Lac, tHb, O2Hb, HHb,COHb, MetHb, SO2 | Oximeter Module |
| cobas b 123 <4> System | pH, BG (pO2, pCO2), ISE (Na+, K+,Ca2+), Hct, Glu, Lac, tHb, O2Hb, HHb,COHb, MetHb, SO2 | AutoQC ModuleandOximeter Module |
Table 1. Versions of the cobas b 123 POC System
(2) cobas b 123 AutoQC Pack Tri-Level:
The cobas b 123 AutoQC pack Tri-Level is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2, PO2, SO2, Na*, K*, iCa2+, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
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Intended use (continued)
(3) cobas® b 123 AutoCVC Pack:
The cobas b 123 AutoCVC pack is a multi-analyte control, intended for use in calibration verification of the measuring range established by the cobas b 123 POC system for pH, PCO2, PO2, SO2, Na+, K+, iCa2+, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
(4) Roche COMBITROL PLUS B:
COMBITROL PLUS B is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2, PO2, SO2, Nat, K+, Cl , iCa2+, Hct, tHb and Hb derivatives as well as glucose, lactate, urea/BUN and bilirubin on Roche OMNI S or cobas b 221 analyzers with an oximeter module, and cobas b 123 analyzers (except urea/BUN, chloride, and bilirubin). COMBITROL PLUS B control material is not intended for use with analyzers from other manufacturers.
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devices
510(k) Summary, Continued
The cobas b 123 POC System is substantially equivalent to other Predicate products in commercial distribution intended for similar use. We claim equivalency to the following currently marketed products:
- cobas b 221 (OMNI S) Blood Gas System-K032311 .
- Hitachi 902 Analyzer (Glucose and Lactate)—K921661 .
- cobas c 501 Analyzer (Glucose and Lactate)-K060373/A001 .
- COMBITROL PLUS B / AUTOTROL PLUS B-K032453 .
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Na*
.
.
Substantial The cobas b 123 POC System is substantially equivalent to other equivalence devices legally marketed in the United States. The cobas b 123 POC System is substantially equivalent to the cobas b 221 (OMNI S Analyzer), cleared on K032311, for the following parameters: K+ O2Hb pH . . · SO2 . iCa2+ pO2 . . HHP ● Hct' pCO2 СОНЫ . . .
tHb
The cobas b 123 POC system is substantially equivalent to the Roche Gluco-Quant Glucose/HK assay on the Hitachi 902 (K921661) and the Roche Glucose HK Assay on the cobas c 501 analyzer (K060373/A001) for the measurement of glucose.
MetHb
.
The cobas b 123 POC system is substantially equivalent to the Roche Lactate assay on the Hitachi 902 analyzer (K921661) and the Lactate Generation 2 (Gen.2) assay on the cobas c 501 analyzer (K060373/A001) for the measurement of lactate. Per 21 CFR 862.1450, a Lactic Acid Test System is exempt to measure lactic acid in whole blood and plasma.
The cobas b 123 AutoOC Pack Tri-Level, cobas b 123 AutoCVC Pack, and COMBITROL PLUS B materials are substantially equivalent to the Roche AUTOTROL PLUS B and Roche COMBITROL PLUS B materials cleared on K032453.
1 Hematocrit measurements on the cobas b 123 POC system were also compared to the hemofuge, which represents the gold standard (reference) method for measurement of hematocrit in blood. This analysis was performed as part of the non-clinical (internal) method comparison study and the results may be located in Section IV (Volume 2) of this Premarket Notification 510(k) submission. Het measurements on the cobas b 123 POC System were compared against the predicate device, cobas b 221, as part of the clinical (external) study; the results may be located in Section V (Volume 3).
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Substantial
equivalence
comparison—
similarities
Table 2 provides the similarities between the cobas b 123 POC System (K111188) and the cobas b 221 predicate device (K032311).
Table 2. Comparison of Candidate (cobas b 123) and Predicate (cobas b 221) Devices—Similarities
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate Devicecobas b 221(K032311) |
|---|---|---|
| Intended Use | The cobas b 123 POC system is a fully automatedPOC system for whole blood in vitro measurementof pH, blood gases (BG), electrolytes Na+, K+, iCa2+(ISE), hematocrit (Hct), metabolites (Glu, Lac), totalhemoglobin (tHb), hemoglobin derivatives (O2Hb,HHb, COHb, MetHb), and oxygen saturation (SO2).In addition, the cobas b 123 POC system calculatesderived parameters.It is dedicated for use in a Point-of-Careenvironment and laboratory. The integrated AutoQCmodule and the oximeter module are available as anoption.Depending on the equipment configuration of theinstrument, the Sensor Cartridge and the Fluid Packused, the following parameters are measured inhuman whole blood and QC materials. See Table 1(page 5). | Same |
| Blood GasMeasurement | pH and pCO2 by potentiometrypO2 by amperometry | Same |
| ElectrolyteMeasurement | K+, Na+, iCa2+ by potentiometry | Same |
| MetaboliteMeasurement | Glucose and Lactate by amperometry | Same |
Continued on next page
Confidential
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Table 2 provides the similarities between the cobas b 123 POC Substantial equivalence System (K111188) and the cobas b 221 predicate device (K032311). comparisonsimilarities (continued)
Table 2. Comparison of Candidate (cobas b 123) and Predicate (cobas b 221) Devices-Similarities, cont.
| Characteristic | Candidate Devicecobas b 123 POC System(K11188) | Predicate Devicecobas b 221(K032311) |
|---|---|---|
| HemoglobinMeasurement | tHb, SO2, O2Hb, HHb, COHb, MetHb:Spectrophotometric | Same |
| HematocritMeasurement | Conductivity | Same |
| Sensor Technology | Amperometric and potentiometric thick filmmicroelectrode array technology forGlucose and Lactate | Same |
| SampleIntroduction | Syringe and capillary aspiration | Same |
| On-Board(In-Use) ReagentStability | Up to 42 days | Same |
| Reagent Tracking | Memory chip technology for identification,lot specifications, usage tracking andtraceability allowing pack to be moved fromone system to another | Same |
| QC Material | COMBITROL PLUS B (manual QC) andAUTOTROL PLUS B (automated QC) | Same |
| Calibration | Two-point liquid calibration | Same |
| Graphical UserInterface | Menu-driven touch screen | Same |
| AdditionalAnalyzer Hardware | Hard drive and printer | Same |
| Operating SystemSoftware | Linux-based | Same |
| System OperatingTemperature | 15-32°C | Same |
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| Substantialequivalencecomparison- | Table 3 provides the similarities between the cobas b 123 POCSystem (K111188) and the following predicate devices: | |
|---|---|---|
| similarities(continued) | • Roche Glucose HK Assays (K921661 and K060703/A001)• Roche Lactate Assays (K921661 and K060703/A001) |
Table 3. Comparison of Candidate and Predicate Devices for Glucose and Lactate Measurement—Similarities
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate DeviceRoche Hitachi Glucose HK Assays:Hitachi 902 (K921661) andcobas c 501 (K060373/A001) |
|---|---|---|
| Test Principle | Enzymatic | Same |
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate DeviceRoche Hitachi Lactate Assays:Hitachi 902 (K921661) andcobas c 501 (K060373/A001) |
| Sample Type | Whole blood | Same |
| Test Principle | Enzymatic | Same |
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| Substantialequivalencecomparison—similarities(continued) | Table 4 provides the similarities between the cobas b 123 AutoQCPack Tri-Level quality control materials (K111188) and the predicatedevice, Roche AUTOTROL PLUS B (K032453). |
|---|---|
| -------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
·
Table 4. Comparison of Candidate and Predicate Devices (AutoQC Materials)-Similarities
| Characteristic | Candidate Devicecobas b 123 AutoQC Pack Tri-Level(K111188) | Predicate DeviceRoche AUTOTROL PLUS B(K032453) |
|---|---|---|
| Number of Levels | 3 | Same |
| Matrix | Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide and oxygengas mixture | Same |
| Technological Characteristics | The material consists of buffered aqueouselectrolyte solutions with clinically relevantconcentrations of the targeted analytes,tonometered with precision gas mixtures ofcarbon dioxide and oxygen to achieve pHand blood gas values that span the range ofvalues typical for such products with thesame intended use. A mixture of dyes is usedto simulate absorbance of hemoglobinderivatives. Hematocrit is simulated byconductivity. | Same |
.
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·
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Substantial equivalence comparisonsimilarities (continued)
Table 5 provides the similarities between the modified Roche COMBITROL PLUS B quality control material (K111188) and the predicate device, Roche COMBITROL PLUS B (K032453).
Table 5. Comparison of Candidate and Predicate Devices (COMBITROL PLUS B)—Similarities
| Characteristic | Candidate DeviceModified COMBITROL PLUS B(K111188) | Predicate DeviceRoche COMBITROL PLUS B(K032453) |
|---|---|---|
| Number of Levels | 3 | Same |
| Fill Volume | 1.7 mL | Same |
| Matrix | Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide and oxygengas mixture | Same |
| Technological Characteristics | The material consists of buffered aqueouselectrolyte solutions with clinically relevantconcentrations of the targeted analytes,tonometered with precision gas mixtures ofcarbon dioxide and oxygen to achieve pHand blood gas values that span the range ofvalues typical for such products with thesame intended use. A mixture of dyes is usedto simulate absorbance of hemoglobinderivatives. Hematocrit is simulated byconductivity. | Same |
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Substantial Table 6 provides the similarities between the cobas b 123 AutoCVC equivalence Pack (K111188) and the predicate device, Roche AUTOTROL comparison-PLUS B (K032453). similarities (continued)
Table 6. Comparison of Candidate and Predicate Devices (CVC Materials)-Similarities
| Characteristic | Candidate Devicecobas b 123 AutoCVC Pack(K111188) | Predicate DeviceRoche AUTOTROL PLUS B(K032453) |
|---|---|---|
| Matrix | Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide and oxygengas mixture | Same. |
| TechnologicalCharacteristics | The material consists of buffered aqueouselectrolyte solutions with clinically relevantconcentrations of the targeted analytes,tonometered with precision gas mixtures ofcarbon dioxide and oxygen to achieve pHand blood gas values that span the range ofvalues typical for such products with thesame intended use. A mixture of dyes is usedto simulate absorbance of hemoglobinderivatives. Hematocrit is simulated byconductivity. | Same. |
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.
510(k) Summary, Continued
| Substantial equivalence comparison-differences | Table 7 provides the differences between the cobas b 123 POC System (K111188) and the cobas b 221 predicate device (K032311). |
|---|---|
| ------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------- |
Table 7. Comparison of Candidate (cobas b 123) and Predicate (cobas b 221) Devices—Differences
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate Devicecobas b 221(K032311) |
|---|---|---|
| Sample Volume | 123 µl | 210 µl |
| Electrochemicalsensors | pH, PO2, PCO2, K+, Na+, iCa2+, Glucose,Reference microelectrode array sensorwith up to 28 days in-use lifeNote: Sensors with Lactate are stable up to21 days. | pH, PO2, PCO2, K+, Na+, Cl-,iCa2+ Reference electrodes with6 to 16 months in-use life,depending on the electrode type. |
| Electrochemicalsensor storagestability | Sensor: 2°C – 8°C for 4 months | Sensor: 25°C for 18 or 24months, depending on electrodetype |
| Auto QCModule | AutoQC Module holds one AutoQC Pack,which is comprised of 24 AUTOTROLPLUS B tri-level ampoules. | QC module holds 120AUTOTROL PLUS B tri-levelampoules. |
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| Substantialequivalencecomparison—differences(continued) | Table 8 provides the differences between the cobas b 123 POCSystem (K111188) and the Roche Glucose HK Assay predicatedevices (K921661 and K060703/A001). |
|---|---|
| ------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Table 8. Comparison of Candidate and Predicate Devices for Glucose Measurement—Differences
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate DeviceRoche Hitachi Glucose HKAssays:Hitachi 902 (K921661) andcobas c 501 (K060373/A001) |
|---|---|---|
| Intended Use | The cobas b 123 POC system is a fullyautomated POC system for whole bloodin vitro measurement of pH, blood gases(BG), electrolytes Na+,K+, iCa2+ (ISE),hematocrit (Hct), metabolites (Glu, Lac),total hemoglobin (tHb), hemoglobinderivatives (O2Hb, HHb, COHb, MetHb),and oxygen saturation (SO2).In addition, the cobas b 123 POC systemcalculates derived parameters.It is dedicated for use in a Point-of-Careenvironment and laboratory. Theintegrated AutoQC module and theoximeter module are available as anoption.Depending on the equipmentconfiguration of the instrument, theSensor Cartridge and the Fluid Pack used,the following parameters are measured inhuman whole blood and QC materials.See Table 1 (page 5). | Gluco-quant Glucose/HK Assay(Hitachi 902): Enzymatic in vitrotest for the quantitativedetermination of glucose in humanserum, plasma, urine and CSF onRoche automated clinicalchemistry analyzers.Glucose HK Assay(cobas c 501):In vitro test for the quantitativedetermination of glucose in humanserum, plasma, urine, CSF andhemolysate on Roche/Hitachicobas c systems. |
| Sample Type | Whole Blood | Serum, plasma, urine, CSF andhemolysate |
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Table 8 provides the differences between the cobas b 123 POC Substantial equivalence System (K11188) and the Roche Glucose HK Assay predicate comparisondevices (K921661 and K060703/A001). differences (continued)
Table 8. Comparison of Candidate and Predicate Devices for Glucose Measurement-Differences, cont.
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate DeviceRoche Hitachi Glucose HK Assays:Hitachi 902 (K921661) andcobas c 501 (K060373/A001) |
|---|---|---|
| MeasurementPrinciple | Amperometric measurement of thedetectable product (H2O2) under apolarization voltage of 350 mV. | UV photometric measurement of thedetectable product (NADPH) at 340 nm. |
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Substantial equivalence comparisondifferences (continued)
Table 9 provides the differences between the cobas b 123 POC System (K111188) and the Roche Lactate Assay predicate devices (K921661 and K060703/A001).
Table 9. Comparison of Candidate and Predicate Devices for Lactate Measurement—Differences
| Characteristic | Candidate Devicecobas b 123 POC System(K111188) | Predicate DeviceRoche Hitachi Lactate Assays:Hitachi 902 (K921661) andcobas c 501 (K060373/A001) |
|---|---|---|
| Intended Use | The cobas b 123 POC system is a fullyautomated POC system for whole bloodin vitro measurement of pH, bloodgases (BG), electrolytes Na+, K+, iCa2+(ISE), hematocrit (Hct), metabolites(Glu, Lac), total hemoglobin (tHb),hemoglobin derivatives (O2Hb, HHb,COHb, MetHb), and oxygen saturation(SO2). In addition, the cobas b 123POC system calculates derivedparameters.It is dedicated for use in a Point-of-Careenvironment and laboratory. Theintegrated AutoQC module and theoximeter module are available as anoption.Depending on the equipmentconfiguration of the instrument, theSensor Cartridge and the Fluid Packused, the following parameters aremeasured in human whole blood andQC materials. See Table 1 (page 5). | Lactate Assay (Hitachi 902): For thequantitative determination ofL-Lactate in plasma, cerebrospinalfluid or whole blood onRoche/Hitachi automated clinicalchemistry analyzers. L-Lactatelevels that evaluate the acid-basestatus are used in the diagnosis andtreatment of lactic acidosis.Lactate Gen. 2 Assay(cobas c 501):In vitro test for the quantitativedetermination of lactate in humanplasma and CSF on Roche/Hitachicobas c systems. |
| MeasurementPrinciple | Amperometric measurement of thedetectable product (H2O2) under apolarization voltage of 350 mV. | UV photometric measurement of thedetectable product (chromogen) at340 nm. |
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| Substantialequivalencecomparison—differences(continued) | Table 10 provides the differences between the cobas b 123 AutoQCPack Tri-Level quality control materials (K111188) and the predicatedevice, Roche AUTOTROL PLUS B (K032453). |
|---|---|
| ------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Table 10. Comparison of Candidate and Predicate Devices (AutoQC Materials)-Differences
| Characteristic | Candidate Devicecobas b 123 AutoQC Pack Tri-Level(K111188) | Predicate DeviceRoche AUTOTROL PLUS B(K032453) |
|---|---|---|
| Intended Use | The cobas b 123 AutoQC packTri-Level is a multi-analyte controlintended for use as control material tomonitor the measurement of pH, pCO2,pO2, SO2, Na+, K+, iCa2+, Hct, tHb andHb derivatives as well as glucose andlactate on cobas b 123 systems with anAutoQC module. | AUTOTROL PLUS B, a Multi-analyte control, is intended for useas a control material to monitor themeasurement of pH, pCO2, pO2,SO2, Na+, K+, Cl-, iCa2+, Hct, tHband Hb derivatives as well asGlucose, Lactate, Urea/BUN andBilirubin on Roche OMNI S andcobas b 221 analyzers with anoximeter module. This controlmaterial is packaged for use with theAutoQC module, an option to theRoche OMNI S and cobas b 221analyzers. AUTO-TROL PLUS Bcontrol material is not intended to beused with analyzers from othermanufacturers. |
| Auto QC Pack | The AutoQC Pack is comprised of 24AUTOTROL PLUS B tri-levelampoules.The AutoQC Pack also contains a smartmemory chip for tracking andtraceability, allowing the pack to bemoved from one system to another. | The QC Pack holds 120AUTOTROL PLUS B tri-levelampoules.The QC Pack does not contain asmart memory chip. |
| Fill Volume | 1.0 mL | 1.7 mL |
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Table 11 provides the differences between the modified Roche Substantial COMBITROL PLUS B quality control material (K111188) and the equivalence comparisonpredicate device, Roche COMBITROL PLUS B (K032453). differences (continued)
Table 11. Comparison of Candidate and Predicate Devices (COMBITROL PLUS B)-Differences
| Characteristic | Candidate DeviceModified COMBITROL PLUS B(K111188) | Predicate DeviceRoche COMBITROL PLUS B(K032453) |
|---|---|---|
| Intended Use | COMBITROL PLUS B is a multi-analyte control intended for use ascontrol material to monitor themeasurement of pH, PCO2, PO2, SO2,Na+, K+, Cl-, iCa2+, Hct, tHb and Hbderivatives as well as glucose, lactate,urea/BUN and bilirubin on RocheOMNI S or cobas b 221 analyzers withan oximeter module, and cobas b 123analyzers (except urea/BUN, chloride,and bilirubin).COMBITROL PLUS B controlmaterial is not intended for use withanalyzers from other manufacturers. | COMBITROL PLUS B, a Multi-analyte control, is intended for useas control material to monitor themeasurement of pH, PCO2, PO2,SO2, Na+, K+, Cl-, iCa2+, Hct, tHband Hb derivatives as well asglucose, lactate, urea/BUN andbilirubin on Roche OMNI S orcobas b 221 analyzers with anoximeter module..COMBITROL PLUS B controlmaterial is not intended for use withanalyzers from other manufacturers. |
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Substantial Table 12 provides the differences between the cobas b 123 AutoCVC equivalence Pack (K111188) and the predicate device, Roche AUTOTROL comparison-PLUS B (K032453). differences (continued)
Table 12. Comparison of Candidate and Predicate Devices (CVC Materials)-Differences
| Characteristic | Candidate Devicecobas b 123 AutoCVC Pack(K111188) | Predicate DeviceRoche AUTOTROL PLUS B(K032453) |
|---|---|---|
| Intended Use | The cobas b 123 AutoCVC pack is a multi-analyte control, intended for use in calibration verification of the measuring range established by the cobas b 123 POC system for pH, PCO2, PO2, SO2, Na+, K+, iCa2+, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module. | AUTOTROL PLUS B, a Multi-analyte control, is intended for use as a control material to monitor the measurement of pH, pCO2, pO2, SO2, Na+, K+, Cl-, iCa2+, Hct, tHb and Hb derivatives as well as Glucose, Lactate, Urea/BUN and Bilirubin on Roche OMNI S and cobas b 221 analyzers with an oximeter module. This control material is packaged for use with the AutoQC module, an option to the Roche OMNI S and cobas b 221 analyzers. AUTO-TROL PLUS B control material is not intended to be used with analyzers from other manufacturers. |
| Indications for Use | The cobas b 123 AutoCVC Pack is an assayed control for use in calibration verification of the measuring range established by the cobas b 123 POC system for analytes listed in the package insert. | COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. |
| Fill Volume | 1.0 mL | 1.7 mL |
The information provided in this Premarket Notification [510(k)] will Conclusion support a determination of substantial equivalence for the cobas b 123 POC System.
End of document
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Image /page/21/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Roche Diagnostics Corporation c/o Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 14 2012
Re: K111188
Trade Name: Cobas® b 123 POC System, Cobas® b 123 AutoQC Pack Tri-Level Cobas® b 123 AutoCVC Pack, Roche COMBITROL PLUS B Regulation Number:21 CFR §862.1120 Regulation Name: Blood gases (PC02, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, GKF, CGA, KHP, KHG, GGZ, GKA, GLY, GHS, JJY Dated May 9, 2012 Received: May 10, 2012
Dear Ms. Baumann:
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 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 (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).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
S. H. Liu, Ph.D.
Countney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K111188
Device Name: cobas® b 123 POC System
Indications for Use:
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Nat, K+, iCa27 (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters.
It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option.
pH, pO2 and pCO2 : pH, pO2 and pCO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Sodium (Na*): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Potassium (K+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Calcium (Ca2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use __ X . AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rute Cene
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K ( 1 ) 8 8
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510(k) Number (if known): K111188
Device Name: cobas® b 123 POC System
Indications for Use, continued:
Hematocrit (Hct): hematocrit measurements are used to distinguish normal from abnormal states of whole blood, such as anemia and erythrocytosis (an increase in the number of red cells).
Glucose (Glu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic. islet cell carcinoma.
Lactate (Lac): Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (tHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
O2Hb: oxyhemoglobin as a fraction of total hemoglobin.
COHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
MetHb: methemoglobin as a fraction of total hemoglobin.
HHb: reduced hemoglobin as a fraction of total hemoglobin.
SO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruti (hm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) ¥ 1 1 1 1 8 8
Page 2 of 4
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510(k) Number (if known): K111188
Device Name: cobas® b 123 AutoQC Pack Tri-Level
Indications for Use:
The cobas b 123 AutoQC pack Tri-Level is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2, PO2, Na , K , iCa *, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
Device Name: cobas® b 123 AutoCVC Pack
Indications for Use:
The cobas b 123 AutoCVC Pack is a multi-analyte control, intended for use in calibration verification of the measuring range established by the cobas b 123 POC system for pH, PCO2, PO2, SO2, Na , K , iCa , Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rute Cima
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 111 88.
Page 3 of 4
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510(k) Number (if known): K111188
Device Name: Roche COMBITROL PLUS B
Indications for Use:
COMBITROL PLUS B is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2, PO2, SO2, Na , K , CI , iCa , Hct, tHb and Ho derivatives as well as glucose, lactate, urea/BUN and bilirubin on Roche OMNI S or cobas b 221 analyzers with an oximeter module, and cobas b 123 analyzers (except urea/BUN, chloride, and bilirubin). COMBITROL PLUS B control material is not intended for use with analyzers from other manufacturers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rose Cieri
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 88
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.