(90 days)
Not Found
No
The document describes a standard in-vitro diagnostic analyzer performing clinical chemistry tests using photometric, turbidimetric, and ISE methods. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on standard analytical metrics like method comparison and precision.
No
The device is described as an "in-vitro diagnostic analyzer" and its intended use is for "performing clinical chemistry, specific protein and electrolyte tests" and "measurements are used in the diagnosis and treatment" of various conditions. It does not directly provide therapy.
Yes
The device is explicitly stated as an "in-vitro diagnostic analyzer" in both the "Intended Use / Indications for Use" and "Device Description" sections. Furthermore, the descriptions for various analytes (AST, CRP, Glucose, ISE Chloride, ISE Potassium, ISE Sodium) mention that their measurements are "used in the diagnosis and treatment of" specific diseases or conditions.
No
The device description explicitly states it is an "in-vitro diagnostic analyzer" capable of performing tests using photometric, turbidimetric, and optional ISE modules, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests..." This directly identifies the device as an IVD.
- Device Description: The description reiterates that it is an "in-vitro diagnostic analyzer".
- Reagents: The descriptions for each reagent (AST, CRP, Glucose, ISE Chloride, ISE Potassium, ISE Sodium) all begin with "In vitro test for the quantitative determination of..." This further confirms that the tests performed by the analyzer are in vitro.
- Nature of the Tests: The tests performed (clinical chemistry, specific protein, and electrolyte tests) are all conducted on biological samples (serum, plasma, urine) outside of the body, which is the definition of in vitro testing.
- Purpose of the Tests: The intended uses of the tests are for diagnosis and treatment of various diseases and conditions (liver and heart disease, tissue injury, carbohydrate metabolism disorders, electrolyte and metabolic disorders, etc.). This aligns with the purpose of IVD devices.
Therefore, based on the provided information, the Roche cobas c 111 analyzer is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CIT, CFR, DCN, CEM, CGZ, JGS, JJE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional setting and small laboratories, specialized testing and CLIA-licensed doctor's offices.
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)
Method Comparison:
AST:
Professional use: y = 0.989x + 1.869 U/L, τ = 0.981, n = 82
Point-of-care use: y = 0.989x + 1.276 U/L, τ = 0.8316, n = 333
Glucose:
Professional use: y = 1.02x - 0.009 mmol/L, τ = 0.983, n = 80
Point-of-care use: y = 0.997x + 2.069 mg/dL, τ = 0.9217, n = 333
CRP:
Professional use: y = 0.995x + 1.334 mg/L, τ = 0.970, n = 63
Point-of-care use: y = 1.058x + 0.022 mg/L, τ = 0.9789, n = 326
ISE-Cl:
Professional use: y = 1.014x - 3.236 mmol/L, r = 0.982, n = 51
Point-of-care use: y = 1.011x - 0.51 mmol/L, τ = 0.7532, n = 280
ISE-K:
Professional use: y = 0.984x - 0.003 mmol/L, r = 1.000, n = 51
Point-of-care use: y = 0.943x + 0.189 mmol/L, τ = 0.8835, n = 280
ISE-Na:
Professional use: y = 0.986x - 0.364 mmol/L, τ = 0.983, n = 51
Point-of-care use: y = 1.064x - 9.818 mmol/L, τ = 0.6920, n = 280
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Precision Within run (CV%/SD):
AST Human Sera: SD 0.37 at 26.2 U/L, 0.5% at 221 U/L (professional); SD 0.78 at 18.98 U/L, 2.07% at 46.92 U/L (point-of-care)
Glucose Human Sera: SD 0.5 at 40.9 mg/dL, 0.8% at 180 mg/dL (professional); 0.56% at 89.14 mg/L, 0.63% at 168.29 mg/L (point-of-care)
CRP Human Sera: SD 0.01 at 0.42 mg/dL, 1.3% at 23.4 mg/dL (professional); SD 0.072 at 0.356 mg/dL, 1.15% at 0.554 mg/dL, 1.23% at 2.385 mg/dL (point-of-care)
ISE – Cl Human Sera: 0.30% at 97 mmol/L, 0.24% at 1.27 mmol/L (professional); 0.72% at 109.03 mmol/L, 0.72% at 98.55 mmol/L (point-of-care)
ISE - K Human Sera: 0.49% at 2.1 mmol/L, 0.40% at 5.7 mmol/L (professional); 0.79% at 4.65 mmol/L, 0.71% at 4.69 mmol/L (point-of-care)
ISE - Na Human Sera: 0.32% at 130 mmol/L, 0.31% at 156 mmol/L (professional); 0.59% at 144.69 mmol/L, 0.61% at 133.70 mmol/L (point-of-care)
Precision Total (CV%/SD unit):
AST Human Sera: SD 0.64 at 19.5 U/L, 1.0% at 306 U/L (professional); SD 1.2 at 16.4 U/L, 3.7% at 48.7 U/L (point-of-care)
Glucose Human Sera: SD 0.2 at 45.4 mg/dL, 0.6% at 178 mg/dL (professional); 2.6% at 97.5 mg/L, 2.8% at 130.7 mg/L (point-of-care)
CRP Human Sera: SD 0.01 at 0.47 mg/dL, 2.6% at 2.33 mg/dL (professional); 3.7% at 4.044 mg/dL, 3.2% at 4.670 mg/L (point-of-care)
ISE – Cl (Between-run) Human sera: 0.44% at 97 mmol/L, 0.48% at 128 mmol/L (professional); 1.4% at 104.7 mmol/L, 1.6% at 104.6 mmol/L (point-of-care)
ISE – K (Between –run) Human Sera: 0.45% at 2.1 mmol/L, 0.30% at 5.7 mmol/L (professional); 1.4% at 4.465 mmol/L, 1.6% at 4.540 mmol/L (point-of-care)
ISE – Na (Between-run) Human Sera: 0.42% at 130 mmol/L, 0.48% at 155 mmol/L (professional); 1.6% at 139.9 mmol/L, 1.6% at 131.6 mmol/L (point-of-care)
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
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.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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)
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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).
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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
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
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