(43 days)
No
The description focuses on standard laboratory analyzer technology using ion-selective electrodes and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) system used for the quantitative determination of specific ion concentrations in biological samples, which aids in diagnosis rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the COBAS INTEGRA ISE module applications are "intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations," which are performed for diagnostic purposes. Additionally, the "Device Description" mentions that the system is used for "in vitro diagnostic testing."
No
The device description clearly outlines a physical analyzer (COBAS INTEGRA Analyzer) that utilizes various measuring principles and hardware components (robotics, barcode readers, reagent cassettes, ion-selective electrodes) to perform in vitro diagnostic testing. The submission focuses on modifications and new applications for the ISE Module, which is part of this larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is for the "quantitative determination of sodium, potassium, chloride, and lithium concentrations using ion-selective electrodes" in biological samples (serum, plasma, and urine). This is a classic definition of an in vitro diagnostic test.
- Device Description: The "Device Description" clearly states that the "COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing."
- Testing Principles: The device utilizes measuring principles (absorbance, fluorescence polarization, and ion-selective electrodes) commonly used in clinical laboratory testing of biological samples.
- Analyte Types: The tests performed (chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents) are all categories of in vitro diagnostic tests.
- Regulatory Context: The document is a "premarket notification," which is a regulatory submission required for certain medical devices, including IVDs, before they can be marketed in the United States. The mention of "clearance" further indicates a regulatory process for medical devices.
- Predicate Devices: The listed predicate devices are also IVD analyzers and reagents used for similar diagnostic purposes.
All of these points strongly indicate that the COBAS INTEGRA ISE module and its associated applications are intended for and function as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COBAS INTEGRA ISE module applications are intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations using ionselective electrodes:
- the direct application is intended for undiluted serum and plasma
- the indirect application is intended for diluted serum and plasma (does not include lithium)
- the urine application is intended for diluted urine (does not include lithium)
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance of a modified ISE Module which includes modified versions of the Direct Sodium, Direct Potassium, and Direct Chloride applications. This premarket notification also includes new ISE applications for Direct Lithium, Indirect Sodium, Indirect Potassium, Indirect Chloride, Urine Sodium, Urine Potassium, and Urine 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
Not Found
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)
Precision Study:
Precision was evaluated using two levels of controls following the guidelines from NCCLS EP5-T2.
Correlation Study:
Correlation studies were done comparing the Sodium, Potassium, Chloride, and Lithium applications with the corresponding applications on the Boehringer Mannheim / Hitachi 911 analyzer and Lithium with the Kodak Ectachem 250 application. Greater than 200 specimens were tested on both systems for each application. The results were evaluated using linear regression analysis.
The specific performance characteristics (precision and accuracy) for each application (Direct Sodium, Direct Potassium, Direct Chloride, Direct Lithium, Indirect Sodium, Indirect Potassium, Indirect Chloride, Urine Sodium, Urine Potassium, Urine Chloride) are presented in tables detailing:
- Test Ranges
- Precision (Mean, %CV within run, %CV total) at various levels
- Accuracy (linear regression equation, correlation coefficient 'r', number of samples 'n', and comparison method e.g., vs. BM / Hitachi 911, vs. flame photometry, vs. chloridometer, vs. Kodak Ectachem, vs. ion-selective electrode).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided include:
- Precision: Mean, %CV (within run), %CV (total)
- Accuracy: Linear regression equation (y=mx+b), correlation coefficient (r)
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.
K912648, K912649, K912647, K924488
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.
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
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (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.(b)
Classification. Class II.
0
OCT 2 4 1996
Image /page/0/Picture/2 description: The image shows the logo for Roche Diagnostic Systems. The logo consists of a hexagon shape on the left and the text "Roche Diagnostic Systems" on the right. Below the text is the phrase "A Member of the Roche Group."
A Member of the Roche Group
Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
Direct Dial Fax
510(k) Summary
Roche COBAS INTEGRA ISE Module Modification
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary as outlined in 21 CFR 807.92 is provided herewith.
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roched, Inc. Branchburg Township 1080 US Highway 202 Somerville, NJ 08876-3771
510(k) Submission dated September 10, 1996
II Description of the Device/Statement of Intended Use:
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer along with 79 COBAS INTEGRA Reagent Cassettes were cleared on September 8, 1995 (K951595), January 25, 1996 (K954992) and July 23, 1996 (K961824). The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective The analyzer has a throughput of up to 600 tests per hour with STAT electrodes. samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with
1
the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance of a modified ISE Module which includes modified versions of the Direct Sodium, Direct Potassium, and Direct Chloride applications. These applications were previously cleared on September 8, 1995 (K951595). This premarket notification also includes new ISE applications for Direct Lithium, Indirect Sodium, Indirect Potassium, Indirect Chloride, Urine Sodium, Urine Potassium, and Urine Chloride.
The COBAS INTEGRA ISE module applications are intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations using ionselective electrodes:
- . the direct application is intended for undiluted serum and plasma
- the indirect application is intended for diluted serum and plasma (does not include . lithium)
- the urine application is intended for diluted urine (does not include lithium) ●
III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
The COBAS INTEGRA ISE Module applications are substantially equivalent to the corresponding applications for the Boehringer Mannheim / Hitachi 911 analyzer or the Kodak Ectachem 250 analyzer.
The ancilliary reagents for the COBAS INTEGRA ISE Module were previously cleared in the original 510(k) for the ISE Module (K951595). However, ISE Solution 1 is now intended to be sold in two new packages with different names. "Calibrator Direct" and in a diluted form as "Calibrator Indirect/Urine". The new containers are larger and are stored on board the instrument, instead of using multiple vials of ISE Solution 1 in the ISE reagent rack.
The following table lists each ISE application and ancilliary reagents with the corresponding predicate device or previously cleared device name.
2
Table of Predicate Devices
| Product Name | Predicate Product Name | K
number | date of
substantial
equivalence |
|------------------------------------------------------------|------------------------------------------|-------------|---------------------------------------|
| Roche COBAS
INTEGRA ISE
Module Tests: | | | |
| Direct Sodium | BM / Hitachi 911 Sodium
(Indirect) | K912648 | 07/17/91 |
| Direct Potassium | BM / Hitachi 911
Potassium (Indirect) | K912649 | 07/15/91 |
| Direct Chloride | BM / Hitachi 911 Chloride
(Indirect) | K912647 | 07/17/91 |
| Direct Lithium | Kodak Ectachem Lithium | K924488 | 01/26/93 |
| Indirect Sodium | BM / Hitachi 911 Sodium
(Indirect) | K912648 | 07/17/91 |
| Indirect Potassium | BM / Hitachi 911
Potassium (Indirect) | K912649 | 07/15/91 |
| Indirect Chloride | BM / Hitachi 911 Chloride
(Indirect) | K912647 | 07/17/91 |
| Urine Sodium | BM / Hitachi 911 Sodium
(Urine) | K912648 | 07/17/91 |
| Urine Potassium | BM / Hitachi 911 (Urine) | K912649 | 07/15/91 |
| Urine Chloride | BM / Hitachi 911 (Urine) | K912647 | 07/17/91 |
| Roche COBAS
INTEGRA ISE
Module Ancillary
Reagents | Previously approved
Product Name | K
Number | date of
substantial
equivalence |
| ISE Solution 1 | ISE Solution 1 | K951595 | 09/08/95 |
| ISE Solution 2 | ISE Solution 2 | K951595 | 09/08/95 |
| ISE Solution 3 | ISE Solution 3 | K951595 | 09/08/95 |
| ISE Calibrator
Direct | ISE Solution 1 | K951595 | 09/08/95 |
| ISE Calibrator
Indirect / Urine | ISE Solution 1 (diluted) | K951595 | 09/08/95 |
IV. Summary of the technological characteristics of the new device in comparison to those of the predicate.
A summary of the similarities, differences and performance characteristics between the COBAS INTEGRA ISE Module applications and the corresponding Boehringer Mannheim / Hitachi 911 or Kodak Ectachem 250 applications are listed in the following tables.
3
Comparison Table - Direct Sodium
| | COBAS INTEGRA
Current ISE Direct
Sodium Application | COBAS INTEGRA
Modified ISE Direct
Sodium Application | Boehringer
Mannheim/Hitachi 911
Sodium |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | quantitative
determination of sodium | quantitative determination
of sodium | quantitative determination of
sodium |
| Sample type | serum and plasma | serum and plasma | serum, plasma and urine |
| Methodology | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Indirect |
| Standards | ISE Sol'n 1: 150 mmol/L
ISE Sol'n 2: 110 mmol/L | ISE Sol'n 1: 150 mmol/L
ISE Sol'n 2: 110 mmol/L | STD 1: 120.0 mmol/L
STD 2: 160.0 mmol/L |
| Performance Characteristics: | | | |
| Test Range | 20 - 250 mmol/L | 20 - 250 mmol/L | 80 - 180 mmol/L |
| Precision:
Mean (mmol/L)
%CV (within run)
%CV (total)
Accuracy | Level 1 Level 2
135.7 153.7
0.40 0.17
1.1 1.6
y= 1.06x - 5.1 mmol/L
r= 0.998 n=100
vs. BM / Hitachi 911 | Level 1 Level 2
116 146
0.32 0.25
1.0 0.69
y= 0.99x + 5.3 mmol/L
r= 0.989 n= 208
vs. BM / Hitachi 911 | Level 1 Level 2 Level 3
128.9 137.5 148.5
0.3 0.2 0.2
0.5 0.4 0.6
y= 1.018x - 2.35 mmol/L
r= 0.999 n= 45
vs. flame photometry |
Comparison Table - Direct Potassium
| | COBAS INTEGRA
Current ISE Direct
Potassium Application | COBAS INTEGRA
Modified ISE Direct
Potassium Application | Boehringer
Mannheim/Hitachi 911
Potassium |
|--------------|--------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|
| Intended Use | quantitative determination
of potassium | quantitative determination
of potassium | quantitative determination
of potassium |
| Sample type | serum and plasma | serum and plasma | serum and plasma |
| Methodology | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Indirect |
| Standards | ISE Sol'n 1: 5 mmol/L
ISE Sol'n 2: 1.8 mmol/L | ISE Sol'n 1: 5 mmol/L
ISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/L
STD 2: 7.00 mmol/L |
Performance Characteristics:
| 0.2 - 30 mmol/L | 0.2 - 30 mmol/L | 1.5 - 10.0 mmol/L | ||||||
|---|---|---|---|---|---|---|---|---|
| Test Range | ||||||||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | Level 3 | |
| Mean (mmol/L) | 3.18 | 7.25 | 4.3 | 7.2 | 3.41 | 5.69 | 6.40 | |
| %CV (within run) | 0.30 | 0.42 | 0.24 | 0.29 | 0.3 | 0.2 | 0.3 | |
| %CV (total) | 1.5 | 1.8 | 0.75 | 0.89 | 0.7 | 0.5 | 0.7 | |
| Accuracy | $y= 1.07x - 0.22$ mmol/L | $y= 1.03x + 0.02$ mmol/L | $y= 1.041x - 0.177$ mmol/L | |||||
| r= 0.999 n=100 | r= 0.998 n= 208 | r=0.999 n=52 | ||||||
| vs. BM / Hitachi 911 | vs. BM / Hitachi 911 | vs. flame photometry |
4
Comparison Table - Direct Chloride
| | COBAS INTEGRA
Current ISE Direct
Chloride Application | COBAS INTEGRA
Modified ISE Direct
Chloride Application | Boehringer
Mannheim/Hitachi 911
Chloride |
|-------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------|
| Intended Use | quantitative determination
of chloride | quantitative determination
of chloride | quantitative determination of
chloride |
| Sample type | serum and plasma | serum and plasma | serum, and urine |
| Methodology | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Direct | Ion Selective Electrode -
Indirect |
| Standards | ISE Sol'n 1: 115 mmol/L
ISE Sol'n 2: 72 mmol/L | ISE Sol'n 1: 115 mmol/L
ISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/L
STD 2: 120.0 mmol/L |
| Performance Characteristics: | | | |
| Test Range | 20 - 250 mmol/L | 20 - 250 mmol/L | 60 - 140 mmol/L |
| Precision:
Mean (mmol/L)
%CV (within run) | Level 1 | Level 1 | Level 1 |
| | 135.7 | 92 | 89.2 |
| | 153.7
0.40
0.17 | 106
0.39
0.37 | Level 2 Level 3
102.2 113.7
0.4 0.3 0.3 |
| %CV (within run) | 0.40 | 0.17 | 0.39 | 0.37 | 0.4 | 0.3 | 0.3 |
|---|---|---|---|---|---|---|---|
| %CV (total) | 1.1 | 1.6 | 1.3 | 0.85 | 0.7 | 0.5 | 0.8 |
| Accuracy | $y= 1.19x - 17.9$ mmol/L | ||||||
| $r= 0.996$ $n=100$ | $y= 0.91x + 12.8$ mmol/L | ||||||
| $r= 0.969$ $n= 208$ | $y= 1.073x - 8.80$ mmol/L | ||||||
| $r= 0.999$ $n= 42$ | |||||||
| vs. BM / Hitachi 911 | vs. BM / Hitachi 911 | vs. chloridometer |
Comparison Table - Direct Lithium
| | COBAS INTEGRA ISE Direct
Lithium Application | Kodak Ectachem Lithium |
|------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | quantitative determination of lithium | quantitative determination of lithium |
| Sample type | serum and plasma | serum and plasma |
| Methodology | Ion Selective Electrode - Direct | Colorimetric |
| Standards | ISE Sol'n 1: 0.3 mmol/L
ISE Sol'n 2: 0.3 mmol/L
ISE Sol'n 3: 1.4 mmol/L | information not available |
| Performance Characteristics: | | |
| Test Range | 0.1 - 4 mmol/L | 0.20 - 4.00 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 Level 4 |
| Mean (mmol/L) | 0.44 1.9 | 0.47 0.96 1.17 2.14 |
| %CV (total) | 3.4 2.9 | 6.93 4.76 3.86 3.12 |
| Accuracy | y= 0.98x - 0.10 mmol/L
r= 0.964 n= 244
vs. Kodak Ectachem | y= 1.00x - 0.03 mmol/L
r= 0.991 n= 200
vs. ion-selective electrode |
5
Comparison Table - Indirect Sodium
:
(
| | COBAS INTEGRA Modified
ISE Indirect Sodium
Application | Boehringer Mannheim/Hitachi
911 Sodium |
|------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | quantitative determination of
sodium | quantitative determination of
sodium |
| Sample type | serum and plasma | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 150 mmol/L
ISE Sol'n 2: 110 mmol/L | STD 1: 120.0 mmol/L
STD 2: 160.0 mmol/L |
| Performance Characteristics: | | |
| Test Range | 20 - 250 mmol/L | 80 - 180 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 112 138 | 128.9 137.5 148.5 |
| %CV (within run) | 0.26 0.24 | 0.3 0.2 0.2 |
| %CV (total) | 1.0 0.59 | 0.5 0.4 0.6 |
| Accuracy | y= 0.96x - 1.2 mmol/L
r= 0.994 n= 208
vs. BM / Hitachi 911 | y= 1.018x - 2.35 mmol/L
r= 0.999 n= 45
vs. flame photometry |
Comparison Table - Indirect Potassium
| | COBAS INTEGRA ISE Indirect
Potassium Application | Boehringer Mannheim/Hitachi
911 Potassium |
|------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | quantitative determination of
potassium | quantitative determination of
potassium |
| Sample type | serum and plasma | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 5 mmol/L
ISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/L
STD 2: 7.00 mmol/L |
| Performance Characteristics: | | |
| Test Range | 0.2 - 30 mmol/L | 1.5 - 10.0 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 4.3 6.9 | 3.41 5.69 6.40 |
| %CV (within run) | 0.44 0.31 | 0.3 0.2 0.3 |
| %CV (total) | 0.75 0.83 | 0.7 0.5 0.7 |
| Accuracy | y= 1.00x - 0.09 mmol/L
r= 0.999 n= 208
vs. BM / Hitachi 911 | y= 1.041x - 0.177 mmol/L
r= 0.999 n= 52
vs. flame photometry |
6
Comparison Table - Indirect Chloride
(
| | COBAS INTEGRA ISE Indirect
Chloride Application | Boehringer Mannheim/Hitachi
911 Chloride |
|------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | quantitative determination of
chloride | quantitative determination of
chloride |
| Sample type | serum and plasma | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 115 mmol/L
ISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/L
STD 2: 120.0 mmol/L |
| Performance Characteristics: | | |
| Test Range | 20 - 250 mmol/L | 60 - 140 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 92 107 | 89.2 102.2 113.7 |
| %CV (within run) | 0.36 0.26 | 0.4 0.3 0.3 |
| %CV (total) | 1.1 0.83 | 0.7 0.5 0.8 |
| Accuracy | y= 0.90x + 11.1 mmol/L
r= 0.980 n= 208
vs. BM / Hitachi 911 | y= 1.073x - 8.80 mmol/L
r= 0.999 n= 42
vs. chloridometer |
Comparison Table - Urine Sodium
| | COBAS INTEGRA ISE Urine
Sodium Application | Boehringer Mannheim/Hitachi
911 Sodium |
|------------------------------|-----------------------------------------------|-------------------------------------------|
| Intended Use | quantitative determination of
sodium | quantitative determination of
sodium |
| Sample type | urine | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 150 mmol/L | STD 1: 120.0 mmol/L |
| | ISE Sol'n 2: 110 mmol/L | STD 2: 160.0 mmol/L |
| Performance Characteristics: | | |
| Test Range | 20 - 350 mmol/L | 10 - 250 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 56 259 | 58.3 107.2 177.4 |
| %CV (within run) | 1.0 0.49 | 0.4 0.3 0.3 |
| %CV (total) | 3.0 1.2 | 1.0 0.6 0.6 |
| Accuracy | y= 0.95x + 3.4 mmol/L | y= 0.963x + 3.06 |
| | r= 0.996 n= 174 | r= 1.000 n= 49 |
| | vs. BM / Hitachi 911 | vs. flame photometry |
7
Comparison Table - Urine Potassium
| | COBAS INTEGRA ISE Urine
Potassium Application | Boehringer Mannheim/Hitachi
911 Potassium |
|------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | quantitative determination of
potassium | quantitative determination of
potassium |
| Sample type | urine | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 5 mmol/L
ISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/L
STD 2: 7.00 mmol/L |
| Performance Characteristics: | | |
| Test Range | 1 - 150 mmol/L | 1.5 - 80 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 33 125 | 22.9 44.1 69.5 |
| %CV (within run) | 0.26 0.67 | 0.4 0.7 0.9 |
| %CV (total) | 1.4 2.0 | 0.8 1.1 1.6 |
| Accuracy | $y= 1.04x - 0.7$ mmol/L
$r= 0.999$ n= 162
vs. BM / Hitachi 911 | $y= 1.035x + 1.45$
$r= 0.999$ n= 42
vs. flame photometry |
Comparison Table - Urine Chloride
| | COBAS INTEGRA ISE Urine
Chloride Application | Boehringer Mannheim/Hitachi
911 Chloride |
|------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | quantitative determination of
chloride | quantitative determination of
chloride |
| Sample type | urine | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 115 mmol/L
ISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/L
STD 2: 120.0 mmol/L |
| Performance Characteristics: | | |
| Test Range | 20 - 350 mmol/L | 1.5 - 80 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 147 274 | 50.3 122.5 202.0 |
| %CV (within run) | 0.44 0.30 | 0.7 0.7 0.6 |
| %CV (total) | 1.1 2.1 | 1.6 0.9 1.2 |
| Accuracy | $y= 0.95x + 11.0$ mmol/L
$r=0.981$ n= 164
vs. BM / Hitachi 911 | $y= 1.033x - 3.08$
$r=0.996$ n= 41
vs. flame photometry |
8
Breif discussion of the clinical and nonclinical tests relied on for a determination V. of substantial equivalence:
To demonstrate equivalence in performance characteristics, the COBAS INTEGRA ISE Module applications were tested for precision and accuracy. See tables in previous section for results.
Precision Study
Precision was evaluated using two levels of controls following the guidelines from NCCLS EP5-T2.
Correlation Study
Correlation studies were done comparing the Sodium, Potassium, Chloride, and Lithium applications with the corresponding applications on the Boehringer Mannheim / Hitachi 911 analyzer and Lithium with the Kodak Ectachem 250 application. Greater than 200 specimens were tested on both systems for each application. The results were evaluated using linear regression analysis.