(43 days)
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) ●
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. 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 provided text describes modifications to the Roche COBAS INTEGRA ISE Module and new ISE applications, along with performance characteristics compared to predicate devices. It focuses on analytical performance rather than clinical studies with human readers or diagnostic accuracy in a clinical setting. Therefore, many of the requested categories are not applicable to this type of device and study.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance for Roche COBAS INTEGRA ISE Module Modifications
The acceptance criteria for each analyte are implied by the "Performance Characteristics" section of each comparison table. The device performance (Modified COBAS INTEGRA ISE Application) is shown alongside these implied criteria and compared to predicate devices. The primary metrics are Test Range, Precision (Mean, %CV within run, %CV total), and Accuracy (linear regression relative to a predicate device or reference method).
Note: For this device, "acceptance criteria" are not explicitly stated as distinct numerical targets but are demonstrated by showing performance that is comparable to or better than established predicate devices. The "reported device performance" is the direct result reported in the tables for the COBAS INTEGRA Modified ISE Applications.
Table of Acceptance Criteria and Reported Device Performance
Due to the volume and nature of the data (comparing against multiple predicate devices and different measurement types), a single comprehensive table would be extremely large. Instead, I will present a summary for one example (Direct Sodium) and describe how to infer the information for others.
Example: Direct Sodium
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Device BM/Hitachi 911) | Reported Device Performance (COBAS INTEGRA Modified ISE Direct Sodium) |
|---|---|---|
| Test Range | 80 - 180 mmol/L | 20 - 250 mmol/L |
| Precision | ||
| Level 1 Mean (mmol/L) | 128.9 | 116 |
| Level 2 Mean (mmol/L) | 137.5 | 146 |
| Level 3 Mean (mmol/L) | 148.5 | N/A (only 2 levels reported) |
| %CV (within run) Level 1 | 0.3 | 0.32 |
| %CV (within run) Level 2 | 0.2 | 0.25 |
| %CV (within run) Level 3 | 0.2 | N/A |
| %CV (total) Level 1 | 0.5 | 1.0 |
| %CV (total) Level 2 | 0.4 | 0.69 |
| %CV (total) Level 3 | 0.6 | N/A |
| Accuracy (Regression) | y= 1.018x - 2.35 mmol/L, r= 0.999 (vs. flame photometry) | y= 0.99x + 5.3 mmol/L, r= 0.989 (vs. BM / Hitachi 911) |
To infer for other applications:
- Acceptance Criteria: Look at the "Predicate Device" columns for the respective analytes (BM/Hitachi 911 or Kodak Ectachem 250) under "Performance Characteristics." These values represent the established performance of legally marketed devices to which equivalence is claimed.
- Reported Device Performance: Look at the "COBAS INTEGRA Modified ISE ... Application" columns under "Performance Characteristics" for the respective analytes.
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Greater than 200 specimens were tested on both systems for each application" in the correlation studies (Sodium, Potassium, Chloride, Lithium). Specific numbers are provided in the accuracy (correlation) sections: n=208 for most modified COBAS INTEGRA ISE applications (Sodium, Potassium, Chloride, Indirect/Urine applications), n=244 for Direct Lithium, n=174 for Urine Sodium, n=162 for Urine Potassium, and n=164 for Urine Chloride.
- Data Provenance: Not explicitly stated. The studies were likely conducted internally by the manufacturer (Roche Diagnostic Systems, Inc.) or a contracted lab. It's not specified if the data is retrospective or prospective, but given they are performance studies for a device, they would typically be prospective for the purpose of generating new performance data. There is no mention of country of origin for the data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in vitro diagnostic device for quantitative determination of analytes. The "ground truth" is established by a reference method or a predicate device, not by expert human interpretation (like in imaging diagnostics).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, this is an analytical performance study for an IVD, not a diagnostic study requiring human expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an MRMC study. It is a comparison of analytical performance between a new device and predicate devices/reference methods. This type of study is not applicable to a laboratory analyzer.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. The performance studies presented are for the device (COBAS INTEGRA ISE Module) operating in a standalone manner. There is no human-in-the-loop component for the analytical measurement reported. The results are generated directly by the automated analyzer.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (reference method) used for accuracy (correlation) studies included:
- Boehringer Mannheim / Hitachi 911 analyzer (for Sodium, Potassium, Chloride – direct, indirect, urine applications)
- Kodak Ectachem 250 analyzer (for Lithium)
- Flame photometry (for Sodium, Potassium, Chloride (predicate device reference))
- Chloridometer (for Chloride (predicate device reference))
- The "ground truth" (reference method) used for accuracy (correlation) studies included:
-
The sample size for the training set:
- Not explicitly stated/Likely not applicable in the traditional sense. For an IVD like this, a "training set" doesn't typically exist in the same way as for machine learning algorithms. The device calibration and algorithm parameters are established during product development and manufacturing based on internal experimentation and characterization, not typically based on a "training set" of patient data that is then separated from a "test set" for regulatory submission. The provided correlation studies are focused on verification of the final product's performance against established methods.
-
How the ground truth for the training set was established:
- Not Applicable. See point 8 above. The establishment of internal "ground truth" for the device's development and calibration would typically involve highly characterized reference materials and methods, but this is part of the engineering and development process, not usually reported as a "training set ground truth" in a 510(k) summary focused on performance data.
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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
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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
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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.
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Table of Predicate Devices
| Product Name | Predicate Product Name | Knumber | date ofsubstantialequivalence |
|---|---|---|---|
| Roche COBASINTEGRA ISEModule Tests: | |||
| Direct Sodium | BM / Hitachi 911 Sodium(Indirect) | K912648 | 07/17/91 |
| Direct Potassium | BM / Hitachi 911Potassium (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 911Potassium (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 COBASINTEGRA ISEModule AncillaryReagents | Previously approvedProduct Name | KNumber | date ofsubstantialequivalence |
| 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 CalibratorDirect | ISE Solution 1 | K951595 | 09/08/95 |
| ISE CalibratorIndirect / 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.
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Comparison Table - Direct Sodium
| COBAS INTEGRACurrent ISE DirectSodium Application | COBAS INTEGRAModified ISE DirectSodium Application | BoehringerMannheim/Hitachi 911Sodium | |
|---|---|---|---|
| Intended Use | quantitativedetermination of sodium | quantitative determinationof sodium | quantitative determination ofsodium |
| 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/LISE Sol'n 2: 110 mmol/L | ISE Sol'n 1: 150 mmol/LISE Sol'n 2: 110 mmol/L | STD 1: 120.0 mmol/LSTD 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 2135.7 153.70.40 0.171.1 1.6y= 1.06x - 5.1 mmol/Lr= 0.998 n=100vs. BM / Hitachi 911 | Level 1 Level 2116 1460.32 0.251.0 0.69y= 0.99x + 5.3 mmol/Lr= 0.989 n= 208vs. BM / Hitachi 911 | Level 1 Level 2 Level 3128.9 137.5 148.50.3 0.2 0.20.5 0.4 0.6y= 1.018x - 2.35 mmol/Lr= 0.999 n= 45vs. flame photometry |
Comparison Table - Direct Potassium
| COBAS INTEGRACurrent ISE DirectPotassium Application | COBAS INTEGRAModified ISE DirectPotassium Application | BoehringerMannheim/Hitachi 911Potassium | |
|---|---|---|---|
| Intended Use | quantitative determinationof potassium | quantitative determinationof potassium | quantitative determinationof 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/LISE Sol'n 2: 1.8 mmol/L | ISE Sol'n 1: 5 mmol/LISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/LSTD 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 |
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Comparison Table - Direct Chloride
| COBAS INTEGRACurrent ISE DirectChloride Application | COBAS INTEGRAModified ISE DirectChloride Application | BoehringerMannheim/Hitachi 911Chloride | |
|---|---|---|---|
| Intended Use | quantitative determinationof chloride | quantitative determinationof chloride | quantitative determination ofchloride |
| 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/LISE Sol'n 2: 72 mmol/L | ISE Sol'n 1: 115 mmol/LISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/LSTD 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 | |
| 153.70.400.17 | 1060.390.37 | Level 2 Level 3102.2 113.70.4 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 DirectLithium 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/LISE Sol'n 2: 0.3 mmol/LISE 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/Lr= 0.964 n= 244vs. Kodak Ectachem | y= 1.00x - 0.03 mmol/Lr= 0.991 n= 200vs. ion-selective electrode |
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Comparison Table - Indirect Sodium
:
(
| COBAS INTEGRA ModifiedISE Indirect SodiumApplication | Boehringer Mannheim/Hitachi911 Sodium | |
|---|---|---|
| Intended Use | quantitative determination ofsodium | quantitative determination ofsodium |
| 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/LISE Sol'n 2: 110 mmol/L | STD 1: 120.0 mmol/LSTD 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/Lr= 0.994 n= 208vs. BM / Hitachi 911 | y= 1.018x - 2.35 mmol/Lr= 0.999 n= 45vs. flame photometry |
Comparison Table - Indirect Potassium
| COBAS INTEGRA ISE IndirectPotassium Application | Boehringer Mannheim/Hitachi911 Potassium | |
|---|---|---|
| Intended Use | quantitative determination ofpotassium | quantitative determination ofpotassium |
| 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/LISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/LSTD 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/Lr= 0.999 n= 208vs. BM / Hitachi 911 | y= 1.041x - 0.177 mmol/Lr= 0.999 n= 52vs. flame photometry |
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Comparison Table - Indirect Chloride
(
| COBAS INTEGRA ISE IndirectChloride Application | Boehringer Mannheim/Hitachi911 Chloride | |
|---|---|---|
| Intended Use | quantitative determination ofchloride | quantitative determination ofchloride |
| 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/LISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/LSTD 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/Lr= 0.980 n= 208vs. BM / Hitachi 911 | y= 1.073x - 8.80 mmol/Lr= 0.999 n= 42vs. chloridometer |
Comparison Table - Urine Sodium
| COBAS INTEGRA ISE UrineSodium Application | Boehringer Mannheim/Hitachi911 Sodium | |
|---|---|---|
| Intended Use | quantitative determination ofsodium | quantitative determination ofsodium |
| 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 |
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Comparison Table - Urine Potassium
| COBAS INTEGRA ISE UrinePotassium Application | Boehringer Mannheim/Hitachi911 Potassium | |
|---|---|---|
| Intended Use | quantitative determination ofpotassium | quantitative determination ofpotassium |
| Sample type | urine | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 5 mmol/LISE Sol'n 2: 1.8 mmol/L | STD 1: 3.00 mmol/LSTD 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= 162vs. BM / Hitachi 911 | $y= 1.035x + 1.45$$r= 0.999$ n= 42vs. flame photometry |
Comparison Table - Urine Chloride
| COBAS INTEGRA ISE UrineChloride Application | Boehringer Mannheim/Hitachi911 Chloride | |
|---|---|---|
| Intended Use | quantitative determination ofchloride | quantitative determination ofchloride |
| Sample type | urine | serum, plasma and urine |
| Methodology | Ion Selective Electrode - Indirect | Ion Selective Electrode - Indirect |
| Standards | ISE Sol'n 1: 115 mmol/LISE Sol'n 2: 72 mmol/L | STD 1: 80.0 mmol/LSTD 2: 120.0 mmol/L |
| Performance Characteristics: | ||
| Test Range | 20 - 350 mmol/L | 1.5 - 80 mmol/L |
| Precision: | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mmol/L) | 147 274 | 50.3 122.5 202.0 |
| %CV (within run) | 0.44 0.30 | 0.7 0.7 0.6 |
| %CV (total) | 1.1 2.1 | 1.6 0.9 1.2 |
| Accuracy | $y= 0.95x + 11.0$ mmol/L$r=0.981$ n= 164vs. BM / Hitachi 911 | $y= 1.033x - 3.08$$r=0.996$ n= 41vs. flame photometry |
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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.
§ 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.