Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated blood gas and chemistry analyzer with electrochemical and optical sensors, fluidics, and a user interface. There is no mention of AI or ML in the device description, intended use, or any other section. The "smart memory chip" is for tracking usage and lot information, not for complex data analysis or learning.

Therapeutic

No
This device is for in vitro measurement of various parameters in whole blood, which is a diagnostic function rather than a therapeutic one. It provides information about a patient's condition, but does not treat or prevent disease.

Diagnostic

Yes
The device is described as a system for "in vitro measurement of pH, blood gases (BG), electrolytes, hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives, and oxygen saturation (SO2)." These measurements are used by healthcare professionals to assess a patient's physiological state, which is a key component of diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a modular analyzer, sensor system, oximeter module, sample and reagent delivery system, and an optional AutoQC module. While it has a software interface, it is an integral part of a larger hardware system.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is for "whole blood in vitro measurement" of various parameters. "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVD devices.
Measurement of Physiological Parameters: The device measures various parameters in blood (pH, blood gases, electrolytes, hematocrit, metabolites, hemoglobin derivatives, oxygen saturation). These measurements are used to provide information about a patient's health status.
Use in Point-of-Care and Laboratory Settings: IVD devices are typically used in clinical settings like laboratories and point-of-care environments to aid in diagnosis, monitoring, or treatment decisions.
Device Description: The description details the components and functionality of a system designed to analyze biological samples (whole blood).

The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

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 insipus, 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).

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.

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, Na , K , iCa *, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.

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 , iCa , Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.

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, 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.

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

CHL, JGS, CEM, JFP, GKF, CGA, KHP, KHG, GGZ, GKA, GLY, GHS, JJY

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-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.

(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.

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

It is dedicated for use in a Point-of-Care environment and laboratory.

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.

K032311, K921661, K060373/A001, K032453

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

Regulation Number and Section

§ 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.

Summary

0

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

1

| 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 Code |
|--------------------------------------|-------------- | PCO2, PO2, pH | Blood pH test system | 21 CFR § 862.1120 | CHL | Na+ (sodium) | Sodium test system | K+ (potassium) | Potassium test system | Ca2+ (Calcium) | Calcium test system | Hct (Hematocrit) | Automated | Glucose | Glucose test system | Lactate | Lactic acid test system | tHb | Whole (tHb) | 21 CFR § 864.7500 | KHG | O2Hb | Whole (Oxyhemoglobin) | 21 CFR § 864.7500 | GGZ | HHb | Deoxyhemoglobin | MetHb | Methemoglobin | SO2 | Oxygen Saturation | COHb (carboxyhemoglobin) | Carboxyhemoglobin assay | cobas b 123 AutoQC Pack
Tri-Level | Quality control material
(assayed and unassayed) | 21 CFR § 862.1660 | JJY | cobas b 123 AutoCVC Pack | | Roche COMBITROL PLUS B | | Regulation Section | Product
---------------------------------------|--------------------|-----------------|
gases (PCO2, PO2) and blood
|
| 21 CFR § 862.1665 | JGS |
| 21 CFR § 862.1600 | CEM |
| 21 CFR § 862.1145 | JFP |
hematocrit instrument | 21 CFR § 864.5600 | GKF |
| 21 CFR § 862.1345 | CGA |
| 21 CFR § 862.1450 | KHP |
blood hemoglobin assays
|
blood hemoglobin assays
|
| 21 CFR § 864.7500 | GKA |
| 21 CFR § 864.5620 | KHG |
| 870.1230 Oximeter | GLY |
| 21 CFR § 864.7425 | GHS |
|
| | |
| | |

Continued on next page

Confidential

2

.

:

·

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

3

(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.

4

(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 System	pH, BG (pO2, pCO2), ISE (Na+, K+,
Ca2+), Hct, Glu, Lac	N/A
cobas b 123 System	pH, BG (pO2, pCO2), ISE (Na+, K+,
Ca2+), Hct, Glu, Lac	AutoQC Module
cobas b 123 System	pH, BG (pO2, pCO2), ISE (Na+, K+,
Ca2+), Hct, Glu, Lac, tHb, O2Hb, HHb,
COHb, MetHb, SO2	Oximeter Module
cobas b 123 System	pH, BG (pO2, pCO2), ISE (Na+, K+,
Ca2+), Hct, Glu, Lac, tHb, O2Hb, HHb,
COHb, MetHb, SO2	AutoQC Module
and
Oximeter 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.

5

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.

6

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 .

7

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).

8

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 Device
cobas b 123 POC System
(K111188) | Predicate Device
cobas b 221
(K032311) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 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. See Table 1
(page 5). | Same |
| Blood Gas
Measurement | pH and pCO2 by potentiometry
pO2 by amperometry | Same |
| Electrolyte
Measurement | K+, Na+, iCa2+ by potentiometry | Same |
| Metabolite
Measurement | Glucose and Lactate by amperometry | Same |

Continued on next page

Confidential

9

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 Device
cobas b 123 POC System
(K11188) | Predicate Device
cobas b 221
(K032311) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Hemoglobin
Measurement | tHb, SO2, O2Hb, HHb, COHb, MetHb:
Spectrophotometric | Same |
| Hematocrit
Measurement | Conductivity | Same |
| Sensor Technology | Amperometric and potentiometric thick film
microelectrode array technology for
Glucose and Lactate | Same |
| Sample
Introduction | Syringe and capillary aspiration | Same |
| On-Board
(In-Use) Reagent
Stability | Up to 42 days | Same |
| Reagent Tracking | Memory chip technology for identification,
lot specifications, usage tracking and
traceability allowing pack to be moved from
one system to another | Same |
| QC Material | COMBITROL PLUS B (manual QC) and
AUTOTROL PLUS B (automated QC) | Same |
| Calibration | Two-point liquid calibration | Same |
| Graphical User
Interface | Menu-driven touch screen | Same |
| Additional
Analyzer Hardware | Hard drive and printer | Same |
| Operating System
Software | Linux-based | Same |
| System Operating
Temperature | 15-32°C | Same |

10

| Substantial
equivalence
comparison- | Table 3 provides the similarities between the cobas b 123 POC
System (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 Device
cobas b 123 POC System
(K111188) | Predicate Device
Roche Hitachi Glucose HK Assays:
Hitachi 902 (K921661) and
cobas c 501 (K060373/A001) |
|----------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Test Principle | Enzymatic | Same |
| Characteristic | Candidate Device
cobas b 123 POC System
(K111188) | Predicate Device
Roche Hitachi Lactate Assays:
Hitachi 902 (K921661) and
cobas c 501 (K060373/A001) |
| Sample Type | Whole blood | Same |
| Test Principle | Enzymatic | Same |

11

| Substantial
equivalence
comparison—
similarities
(continued) | Table 4 provides the similarities between the cobas b 123 AutoQC
Pack Tri-Level quality control materials (K111188) and the predicate
device, Roche AUTOTROL PLUS B (K032453). |

--------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

·

Table 4. Comparison of Candidate and Predicate Devices (AutoQC Materials)-Similarities

| Characteristic | Candidate Device
cobas b 123 AutoQC Pack Tri-Level
(K111188) | Predicate Device
Roche AUTOTROL PLUS B
(K032453) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Number of Levels | 3 | Same |
| Matrix | Buffered, aqueous electrolyte solution
equilibrated with carbon dioxide and oxygen
gas mixture | Same |
| Technological Characteristics | The material consists of buffered aqueous
electrolyte solutions with clinically relevant
concentrations of the targeted analytes,
tonometered with precision gas mixtures of
carbon dioxide and oxygen to achieve pH
and blood gas values that span the range of
values typical for such products with the
same intended use. A mixture of dyes is used
to simulate absorbance of hemoglobin
derivatives. Hematocrit is simulated by
conductivity. | Same |

.

Continued on next page

·

12

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 Device
Modified COMBITROL PLUS B
(K111188) | Predicate Device
Roche COMBITROL PLUS B
(K032453) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Number of Levels | 3 | Same |
| Fill Volume | 1.7 mL | Same |
| Matrix | Buffered, aqueous electrolyte solution
equilibrated with carbon dioxide and oxygen
gas mixture | Same |
| Technological Characteristics | The material consists of buffered aqueous
electrolyte solutions with clinically relevant
concentrations of the targeted analytes,
tonometered with precision gas mixtures of
carbon dioxide and oxygen to achieve pH
and blood gas values that span the range of
values typical for such products with the
same intended use. A mixture of dyes is used
to simulate absorbance of hemoglobin
derivatives. Hematocrit is simulated by
conductivity. | Same |

13

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 Device
cobas b 123 AutoCVC Pack
(K111188) | Predicate Device
Roche AUTOTROL PLUS B
(K032453) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Matrix | Buffered, aqueous electrolyte solution
equilibrated with carbon dioxide and oxygen
gas mixture | Same. |
| Technological
Characteristics | The material consists of buffered aqueous
electrolyte solutions with clinically relevant
concentrations of the targeted analytes,
tonometered with precision gas mixtures of
carbon dioxide and oxygen to achieve pH
and blood gas values that span the range of
values typical for such products with the
same intended use. A mixture of dyes is used
to simulate absorbance of hemoglobin
derivatives. Hematocrit is simulated by
conductivity. | Same. |

14

.

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 Device
cobas b 123 POC System
(K111188) | Predicate Device
cobas b 221
(K032311) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Sample Volume | 123 µl | 210 µl |
| Electrochemical
sensors | pH, PO2, PCO2, K+, Na+, iCa2+, Glucose,
Reference microelectrode array sensor
with up to 28 days in-use life

Note: Sensors with Lactate are stable up to
21 days. | pH, PO2, PCO2, K+, Na+, Cl-,
iCa2+ Reference electrodes with
6 to 16 months in-use life,
depending on the electrode type. |
| Electrochemical
sensor storage
stability | Sensor: 2°C – 8°C for 4 months | Sensor: 25°C for 18 or 24
months, depending on electrode
type |
| Auto QC
Module | AutoQC Module holds one AutoQC Pack,
which is comprised of 24 AUTOTROL
PLUS B tri-level ampoules. | QC module holds 120
AUTOTROL PLUS B tri-level
ampoules. |

15

| Substantial
equivalence
comparison—
differences
(continued) | Table 8 provides the differences between the cobas b 123 POC
System (K111188) and the Roche Glucose HK Assay predicate
devices (K921661 and K060703/A001). |

-------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 8. Comparison of Candidate and Predicate Devices for Glucose Measurement—Differences

| Characteristic | Candidate Device
cobas b 123 POC System
(K111188) | Predicate Device
Roche Hitachi Glucose HK
Assays:
Hitachi 902 (K921661) and
cobas c 501 (K060373/A001) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
See Table 1 (page 5). | Gluco-quant Glucose/HK Assay
(Hitachi 902): Enzymatic in vitro
test for the quantitative
determination of glucose in human
serum, plasma, urine and CSF on
Roche automated clinical
chemistry analyzers.

Glucose HK Assay
(cobas c 501):
In vitro test for the quantitative
determination of glucose in human
serum, plasma, urine, CSF and
hemolysate on Roche/Hitachi
cobas c systems. |
| Sample Type | Whole Blood | Serum, plasma, urine, CSF and
hemolysate |

16

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 Device
cobas b 123 POC System
(K111188) | Predicate Device
Roche Hitachi Glucose HK Assays:
Hitachi 902 (K921661) and
cobas c 501 (K060373/A001) |
|--------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Measurement
Principle | Amperometric measurement of the
detectable product (H2O2) under a
polarization voltage of 350 mV. | UV photometric measurement of the
detectable product (NADPH) at 340 nm. |

17

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 Device
cobas b 123 POC System
(K111188) | Predicate Device
Roche Hitachi Lactate Assays:
Hitachi 902 (K921661) and
cobas c 501 (K060373/A001) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. See Table 1 (page 5). | Lactate Assay (Hitachi 902): For the
quantitative determination of
L-Lactate in plasma, cerebrospinal
fluid or whole blood on
Roche/Hitachi automated clinical
chemistry analyzers. L-Lactate
levels that evaluate the acid-base
status are used in the diagnosis and
treatment of lactic acidosis.
Lactate Gen. 2 Assay
(cobas c 501):
In vitro test for the quantitative
determination of lactate in human
plasma and CSF on Roche/Hitachi
cobas c systems. |
| Measurement
Principle | Amperometric measurement of the
detectable product (H2O2) under a
polarization voltage of 350 mV. | UV photometric measurement of the
detectable product (chromogen) at
340 nm. |

18

| Substantial
equivalence
comparison—
differences
(continued) | Table 10 provides the differences between the cobas b 123 AutoQC
Pack Tri-Level quality control materials (K111188) and the predicate
device, Roche AUTOTROL PLUS B (K032453). |

-------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 10. Comparison of Candidate and Predicate Devices (AutoQC Materials)-Differences

| Characteristic | Candidate Device
cobas b 123 AutoQC Pack Tri-Level
(K111188) | Predicate Device
Roche AUTOTROL PLUS B
(K032453) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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, 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. |
| Auto QC Pack | The AutoQC Pack is comprised of 24
AUTOTROL PLUS B tri-level
ampoules.

The AutoQC Pack also contains a smart
memory chip for tracking and
traceability, allowing the pack to be
moved from one system to another. | The QC Pack holds 120
AUTOTROL PLUS B tri-level
ampoules.

The QC Pack does not contain a
smart memory chip. |
| Fill Volume | 1.0 mL | 1.7 mL |

19

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 Device
Modified COMBITROL PLUS B
(K111188) | Predicate Device
Roche COMBITROL PLUS B
(K032453) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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+, 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. | COMBITROL PLUS B, a Multi-
analyte control, is intended for use
as 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 or
cobas b 221 analyzers with an
oximeter module..
COMBITROL PLUS B control
material is not intended for use with
analyzers from other manufacturers. |

20

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 Device
cobas b 123 AutoCVC Pack
(K111188) | Predicate Device
Roche 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

21

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).

22

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

23

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

24

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

25

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

26

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