Who is the manufacturer of COBAS C 111 ANALYZER?

Roche Diagnostics filed the 510(k) submission for COBAS C 111 ANALYZER (K071211).

What is the FDA product code for COBAS C 111 ANALYZER?

CIT. It is classified under 21 CFR 862.1100 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for COBAS C 111 ANALYZER?

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

What are the predicate devices for COBAS C 111 ANALYZER?

cobas c 111 Analyzer (K063744).

Who can help prepare an FDA 510(k) submission like COBAS C 111 ANALYZER?

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

COBAS C 111 ANALYZER

K071211 · Roche Diagnostics · CIT · Jul 30, 2007 · Clinical Chemistry

Device Facts

Record ID	K071211
Device Name	COBAS C 111 ANALYZER
Applicant	Roche Diagnostics
Product Code	CIT · Clinical Chemistry
Decision Date	Jul 30, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1100
Device Class	Class 2

Intended Use

The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests in the professional setting and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Device Story

Cobas c 111 analyzer performs clinical chemistry, specific protein, and electrolyte testing. Inputs: human serum, plasma, or urine samples. Operation: photometric/turbidimetric assays or optional ion-selective electrode (ISE) module. Output: quantitative analyte concentrations. Used in professional settings, small labs, and CLIA-licensed doctor's offices by trained technicians. Healthcare providers use results for diagnosis and monitoring of liver/heart disease, diabetes, tissue injury, and electrolyte imbalances. System provides automated analysis to support clinical decision-making at point-of-care.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison studies (n=280-333) against the Integra 400 analyzer, demonstrating high correlation (Passing Bablok regression). Precision studies (within-run and total CV%) conducted on human sera and controls for all analytes (AST, Glucose, CRP, ISE-Cl/K/Na). Interference studies confirmed no significant impact from common drugs, bilirubin, hemolysis, or lipemia within specified limits.

Technological Characteristics

Photometric/turbidimetric analyzer with optional ISE module. Reagents include enzymes (MDH, hexokinase, G6PDH), latex particles, and buffers. ISE module uses neutral carrier (Na, K) and ion exchanger (Cl) electrodes. Standardized against IFCC, ID/MS, or gravimetric primary calibrators. Complies with CLSI EP5-A for precision.

Indications for Use

Indicated for professional use in small labs, specialized testing, and CLIA-licensed doctor's offices for quantitative determination of AST, glucose, CRP, sodium, potassium, and chloride in human serum, plasma, and urine (electrolytes only). Used for diagnosis/treatment of liver/heart disease, carbohydrate metabolism disorders, tissue injury, and electrolyte/metabolic disorders.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

cobas c 111 Analyzer (K063744)

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ K071211 ## JUL 3 0 2007 # 510(k) Summary | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------|---------------------| | Submitter name, address, contact | Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 317-521-3831 Contact Person: Corina Harper Date Prepared: April 2007 | | | | | Device name | Proprietary name: cobas c 111 Analyzer Common name: Analyzer, Chemistry (Photometric, Discrete), for clinical use Classification name: Discrete photometric chemistry analyzer for clinical use | | | | | Establishment information | The establishment registration number for Roche Diagnostics Ltd. is 3003795116. The establishment registration number for Roche Diagnostics GmbH is 9610126. The establishment registration number for Roche Diagnostics Corporation is 1823260. | | | | | Classification | The FDA has classified a discrete photometric analyzer in Class I. | | | | | | Panel | Classification Number | Classification Name | Regulation Citation | | | 75 Clinical Chemistry | 1 | Discrete photometric chemistry analyzer for clinical use | 21 CFR 862.2160 | {1}------------------------------------------------ | Performance standards | To date, no performance standards that affect this device have been finalized under Section 514 of the Act. | |-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission history | The cobas c111 analyzer is a member of the COBAS INTEGRA® family of analyzers cleared in the Total Bilirubin reagent submission as K063744. The reagents applied to this analyzer are cleared reagents for the COBAS INTEGRA family of analyzers and were successfully applied to the cobas c 111 analyzer using the Replacement Reagent and Instrument Family Policy - Dec 11, 2003, to demonstrate equivalence to the original reagent/instrument performance. | | Device modification - Additional indication for cobas c 111 analyzer | The table below compares the additional intended use for the device, cobas c 111 analyzer to the current device, cobas c 111 for professional use. | | Topic | cobas c 111 Analyzer professional use (K063744) | cobas c 111 Analyzer with extended intended use | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Analyzer Description | | | | Intended Use/Indications of Use | The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. | The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests in the professional setting and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride | : {2}------------------------------------------------ Device modifications reagents comparison The following table compares the panel of six assays performance characteristics on cobas c 111 analyzer for professional use with the point-ofcare use. | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of- care use | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Intended Use for representative reagents | AST: In vitro test for the quantitative determination of aspartate aminotransferase (AST) in human serum and plasma on the cobas c 111 system. Glucose: In vitro test for the quantitative determination of glucose in human serum and plasma on the cobas c 111 system. CRP: In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on the cobas c 111 system. ISE-C1: The chloride electrode for the cobas c 111 system is intended for the quantitative determination of chloride in diluted serum, plasma and urine. ISE-K: The potassium electrode for the cobas c 111 system is intended for the quantitative determination of chioride in diluted serum, plasma and urine. ISE-Na: The sodium electrode for the cobas c 111 system is intended for the quantitative determination of chloride in diluted serum, plasma and urine. | Same | | Instrument | cobas c 111 analyzer | Same | | Operator | Professional setting | Point-of-care setting | | Sample type | AST: serum and plasma Glucose: serum and plasma CRP: serum and plasma ISE-Cl: serum, plasma and urine ISE-K: serum, plasma and urine ISE-Na: serum, plasma and urine | Same | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Traceability/ Standardization | AST: standardized against the original IFCC formulation using calibrated pipettes together with manual photometer providing absolute values and the substrate- specific absorptivity, $ε$ Glucose: standardized against ID/MS CRP: standardized against the reference preparation of the IRMM - BCR470/ CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum) ISE-Cl/K/Na: standardized against primary calibrators prepared gravimetrically from purified salts | Same | | Measuring range | AST: 2-700 U/L Glucose: 0.11-40 mmol/L CRP: 1-200 mg/L ISE-Cl: 20-250 mmol/L ISE-K: 1-100 mmol/L ISE-Na: 20-250 mmol/L | Same | | Analytical sensitivity (LDL) | AST: 2 U/L Glucose: 0.11 mmol/L CRP: 1.0 mg/L ISE-Cl: slope range -25 to -56 mV/dec ISE-K: slope range 45 to 63 mV/dec ISE-Na: slope range 45 to 63 mV/dec | Same | {3}------------------------------------------------ Device modifications – reagents comparison (continued) Continued on next page {4}------------------------------------------------ | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Precision Within run (CV%/SD) | AST Human Sera : SD 0.37 at 26.2 U/L 0.5% at 221 U/L Controls: 1.1% at 39.7 U/L 0.4% at 123 U/L | Human sera: SD 0.78 at 18.98 U/L 2.07% at 46.92 U/L Controls: 1.99% at 41.05 U/L 0.63% at 137.93 U/L | | | Glucose Human Sera: SD 0.5 at 40.9 mg/dL 0.8% at 180 mg/dL Controls: 1.0% at 90.6 mg/dL 0.5% at 252 mg/dL | Human sera: 0.56% at 89.14 mg/L 0.63% at 168.29 mg/L Controls: 0.63% at 96.11 mg/L 0.66% at 255.47 mg/L | | | CRP Human Sera: SD 0.01 at 0.42 mg/dL 1.3% at 23.4 mg/dL Controls: 0.8% at 1.83 mg/dL 0.6% at 3.77 mg/dL | Human sera: SD 0.072 at 0.356 mg/dL 1.15%-- 0t 0.554 mg/dL 1.23% at 2.385 mg/dL Controls: 0.68% at 0.842 mg/dL 0.41% at 4.792 mg/dL | | | ISE – Cl Human Sera: 0.30% at 97 mmol/L 0.24% at 1.27 mmol/L Plasma: 0.29% at 93 mmol/L | Human sera: 0.72% at 109.03 mmol/L 0.72% at 98.55 mmol/L Controls: SD 0.43 at 86.22 mmol/L | Device modifications – reagents comparison (continued) {5}------------------------------------------------ | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point- of-care use | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Precision Within run (CV%) | ISE - K Human Sera: 0.49% at 2.1 mmol/L 0.40% at 5.7 mmol/L Plasma: 0.41% at 2.0 mmol/L 0.32% at 60. mmol/L | Human sera: 0.79% at 4.65 mmol/L 0.71% at 4.69 mmol/L Controls: 0.47% at 3.465 mmol/L SD 0.040 at 6.621 mmol/L | | | ISE - Na Human Sera: 0.32% at 130 mmol/L 0.31% at 156 mmol/L Plasma 0.31% at 127 mmol/L 0.30% at 151 mmol/L | Human sera: 0.59% at 144.69 mmol/L 0.61% at 133.70 mmol/L Controls: 0.39% at 126.66 mmol/L 0.41% at 150.50 mmol/L | | Precision Total (CV%/SD unit) | AST Human Sera: SD 0.64 at 19.5 U/L 1.0% at 306 U/L Controls: 2.4% at 38.6 U/L 0.9% at 126 U/L | Human sera: SD 1.2 at 16.4 U/L 3.7% at 48.7 U/L Controls: 3.3% at 40.24 U/L 2.2% at 137.04 U/L | | | Glucose Human Sera: SD 0.2 at 45.4 mg/dL 0.6% at 178 mg/dL Controls: 0.7% at 92.3 mg/dL 0.5% at 254 mg/dL | Human sera: 2.6% at 97.5 mg/L 2.8% at 130.7 mg/L Controls: 2.5% at 93.03 mg/L 2.5% at 247.08 mg/L | Device modifications - reagents comparison (continued) {6}------------------------------------------------ | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | |--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Precision Total (CV%/SD unit) | CRP Human Sera: SD 0.01 at 0.47 mg/dL 2.6% at 2.33 mg/dL Controls: 2.1% at 1.86 mg/dL 1.6% at 3.84 mg/dL | Human sera: 3.7% at 4.044 mg/dL 3.2% at 4.670 mg/L Controls: 2.6% at 0.835 mg/dL 2.9% at 4.764 mg/dL | | | ISE – Cl (Between-run) Human sera: 0.44% at 97 mmol/L 0.48% at 128 mmol/L Plasma (Between-run): 0.51% at 93 mmol/L 0.67% at 125 mmol/L | Human sera: 1.4% at 104.7 mmol/L 1.6% at 104.6 mmol/L Controls: SD 2.0 at 87.16 mmol/L 2.0% at 119.97 mmol/L | | | ISE – K (Between –run) Human Sera: 0.45% at 2.1 mmol/L 0.30% at 5.7 mmol/L Plasma (Between-run) 0.78% at 2.0 mmol/L 0.72% at 6.0 mmol/L | Human sera: 1.4% at 4.465 mmol/L 1.6% at 4.540 mmol/L Controls: 1.8% at 3.466 mmol/L SD 1.8 at 6.646 mmol/L | | | ISE – Na (Between-run) Human Sera: 0.42% at 130 mmol/L 0.48% at 155 mmol/L Plasma: 0.80% at 128 mmol/L 0.75% at 151 mmol/L | Human sera: 1.6% at 139.9 mmol/L 1.6% at 131.6 mmol/L Controls: 1.8% at 126.48 mmol/L 1.7% at 151.0 mmol/L | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Limitations - interferences | AST: Bilirubin- no interference up to I index of 67 (conjugated) and I index of 65 (unconjugated) Hemolysis: elevated results with contamination of erythrocytes Lipemia: interferences Anticoagulants: citrate and fluoride interfere Glucose: Bilirubin– no interference up to I index of 67 (conjugated or unconjugated) Hemolysis: no interference up to H index of 1046 Lipemia: no interference up to L index of 2126 CRP: Bilirubin– no interference up to I index of 60 (conjugated or unconjugated) Hemolysis: no interference up to H index of 700 Lipemia: no interference up to L index of 700 Rheumatoid factors up to 1200 IU/mL do not interfere No high dose hook-effect is seen up to a CRP concentration of 3100 mg/L | Same | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Limitations - interferences | ISE-Cl: Serum/Plasma: Hemolysis: Avoid hemolyzed samples. No significant interferences up to a hemoglobin level of 10 g/L Bilirubin/Lipemia: No significant interferences | Same | | | ISE-K: Serum/Plasma: Hemolysis: Avoid hemolyzed samples. No significant interferences up to a hemoglobin level of 1 g/L. Potassium centration in erythrocytes is 25 times higher than in normal plasma. The level of interference may be variable depending on the excat content of erythrocytes. Bilirubin/Lipemia: No significant interferences | | | | ISE-Na: Serum/Plasma: Hemolysis: Avoid hemolyzed samples. No significant interferences up to a hemoglobin level of 10 g/L Bilirubin/Lipemia: No significant interferences | | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Endogenous interferences | AST: No interferences found using common drug panel, except: Doxycycline HCl causes artificially low results Glucose: No interferences found using common drug panel. CRP: No interferences found using common drug panel. ISE-Cl: Serum/Plasma: Panel of drugs tested causes no significant interferences Salicylic acid in concentration of 5 mmol/L causes artificially elevated results Urine: Panel of drugs tested causes no significant interferences, except: Salicylic acid, Ca-dobesilate and Na- cefoxitin which causes artificially elevated Cl concentrations ISE-K: Serum/Plasma: | Same | | | Panel of drugs tested causes no significant interferences up to the indicated concentration. Urine: Panel of drugs tested causes no significant interferences up to the indicated concentration. | | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Endogenous interferences | ISE-Na: Serum/Plasma: Panel of drugs tested causes no significant interferences up to the indicated concentration. Urine: Panel of drugs tested causes no significant interferences up to the indicated concentration. pH – Acidified urines can give false results. | Same | | Calibration frequency | AST/Glucose/CRP: Each lot and as required following quality control procedures ISE-CI/K/Na: 24 hours (main calibration) After ISE cleaning and maintenance, changing reagent bottles, replacing electrodes | Same | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Method Comparison Professional use y = cobas c 111 x = Integra 400 | AST: Passing Bablok: y = 0.989x + 1.869 U/L $\tau$ = 0.981 n = 82 | AST: Passing Bablok: y = 0.989x + 1.276 U/L $\tau$ = 0.8316 n = 333 | | Point-of-care use: y = cobas c 111 x = Integra 400 | Glucose: y = 1.02x - 0.009 mmol/L $\tau$ = 0.983 n = 80 | Glucose: y = 0.997x + 2.069 mg/dL $\tau$ = 0.9217 n = 333 | | | CRP: y = 0.995x + 1.334 mg/L $\tau$ = 0.970 n = 63 | CRP: y = 1.058x + 0.022 mg/L $\tau$ = 0.9789 n = 326 | | | ISE-Cl: y = 1.014x - 3.236 mmol/L r = 0.982 n = 51 | ISE-Cl: y = 1.011x - 0.51 mmol/L $\tau$ = 0.7532 n = 280 | | | ISE-K: y = 0.984x - 0.003 mmol/L r = 1.000 n = 51 | y = 0.943x + 0.189 mmol/L $\tau$ = 0.8835 n = 280 | | | ISE-Na: y = 0.986x - 0.364 mmol/L $\tau$ = 0.983 n = 51 | ISE-Na: y = 1.064x - 9.818 mmol/L $\tau$ = 0.6920 n = 280 | | Feature | Reagent performance characteristics on cobas c 111 analyzer for professional use | Reagent performance characteristics for point-of-care use | | Expected values (from reference) (also please reference method sheet) | AST: Female: up to 32 U/L Males: up to 38 U/L Glucose: Plasma fasting: 3.88-6.38 mmol/L Serum/Plasma Adults: 4.11-5.89 mmol/L CRP: Adults: less than 5 mg/L ISE-C1: Serum/Plasma (adults): 98-107 mmol/L Urine (24h, adults): 110-250 mmol/L ISE-K: Serum (adults): 3.5-5.1 mmol/L Plasma (adults): 3.4-4.5 mmol/L Urine (24h, adults) 25-125 mmol/L ISE-Na: Serum (adults): 136-145 mmol/L Plasma (adults): 136-145 mmol/L Urine (24h, adults): 40-220 mmol/L | Same | Device modifications – reagents comparison (continued) {7}------------------------------------------------ Device modifications – reagents comparison (continued) Continued on next page . {8}------------------------------------------------ . Device modifications - reagents comparison (continued) {9}------------------------------------------------ Device modifications - reagents comparison (continued) Continued on next page . {10}------------------------------------------------ Device modifications – reagents comparison (continued) {11}------------------------------------------------ #### Device modifications -- reagents comparison (continued) {12}------------------------------------------------ Device modifications - reagents comparison (continued) {13}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. The text is in all capital letters. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Roche Diagnostics Corporation c/o Corina Harper, Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250 JUL 3 0 2007 Re: k071211 Trade/Device Name: cobas c 111 analyzer and applied reagents Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGO) test system Regulatory Class: Class II Product Code: CIT, CFR, DCN, CEM, CGZ, JGS, JJE Dated: April 30, 2007 Received: May 1, 2007 Dear Ms. Harper: 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {14}------------------------------------------------ Page 2 -- This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Jean M. Cooper, M.S., D.V.M. Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {15}------------------------------------------------ #### Indications for Use 510(k) Number (if known): Device Name: cobas c 111 analyzer and applied reagents Indications For Use: cobas c 111 analyzer: The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. #### Reagents: Aspartate aminotransferase (ASTL/ASTPL) In vitro test for the quantitative determination of AST in human serum and plasma on the cobas c1 11 system. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Prescription Use XXXX (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 IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) CarolC. Benam Sign-O ്ffice of In Vitro Diagnostic Device Evaluation and Safety K071211 {16}------------------------------------------------ #### Indications for Use 510(k) Number (if known): _ K071211 Device Name: cobas c 111 analyzer and reagents Indications For Use: C-Reactive Protein Latex (CRPLX) In vitro test for the quantitative immunological determination of human C-reactive protein in human serum and plasma on the cobas c111 system. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. Glucose HK (GLUC2) In vitro test for the quantitative determination of glucose concentration in human serum and plasma on the cobas c111 system. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. #### ISE Chloride Electrode The chloride electrode for the cobas c111 system is intended for the quantitative determination of chloride in diluted serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Prescription Use XXXX (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 IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Carol C. Benson on Sign-Off Page 2 of 3 ice of In Vitro Diagnostic Device Juation and Safety K071211 {17}------------------------------------------------ #### Indications for Use 510(k) Number (if known): Device Name: cobas c 111 analyzer and reagents Indications For Use: ISE Potassium Electrode The potassium electrode for the cobas c111 system is intended for the quantitative determination of potassium in diluted serum, plasma, and urine. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. ISE Sodium Electrode The sodium electrode for the cobas c111 system is intended for the quantitative determination of sodium in diluted serum, plasma, and urine. Measurements of sodium are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Prescription Use XXXX (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 IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 3 of 3 Sign-Off be of In Vitro Diagnostic Device uation and Safety 4071211

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