(97 days)
No
The description focuses on the electrochemical principles of Ion-Selective Electrodes and standard analytical performance metrics, with no mention of AI or ML.
No.
The device is an in vitro diagnostic tool used for the measurement of electrolytes to aid in the diagnosis and treatment of conditions involving electrolyte imbalance; it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance."
No
The device description explicitly states it is an Ion-Selective Electrode (ISE) system, which is a hardware-based analytical instrument, and refers to detailed hardware information in a previous submission.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro potentionetric determination of chloride, potassium, and sodium in serum, plasma, and urine ion-selective electrodes." The phrase "in vitro" is a key indicator of an IVD.
- Purpose: The intended use also states that the measurements obtained are "used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance." This clearly indicates a medical purpose related to diagnosis and treatment, which is characteristic of IVDs.
- Sample Types: The device analyzes biological samples (serum, plasma, and urine), which are typical for IVD testing.
- Device Description: The description details a laboratory instrument designed to perform analytical tests on these biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ
Device Description
The cobas 8000 ISE module is an Ion-Selective Electrode (ISE) system for the determination of sodium, potassium, and chloride in serum, plasma, and urine. The cobas 8000 ISE module and the ISE Gen 2 reagents were previously cleared for serum and plasma sample types under K100853 and urine sample type on K123726.
This premarket notification seeks to obtain FDA review and clearance for the urine sample type for the ISE Gen 2 reagents on the cobas 8000 ISE module using an expanded measuring range for sodium and chloride analytes at the low end of the measuring range and the new calibration method cleared in K132418.
An ISE makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution. The internal filling solution contains the test ion at a fixed concentration. Because of the particular nature of the membrane, the test ions will closely associate with the membrane on each side. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution. The EMF develops according to the Nernst equation for a specific ion in solution (see package insert for further explanation). Please refer to K 100853 for detailed hardware and software information relating to the cobas 8000 modular analyzer series.
Commercially available controls are recommended for the urine sample type. Aqueous ISE standards Low and High were cleared under K053165. The LHH calibration scheme was cleared under K132418.
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)
The cobas 8000 ISE Module, Urine Sample Type was evaluated for several performance characteristics, including repeatability, intermediate precision, LoB, LoD, LoQ, method comparison, recovery in controls, and linearity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sodium (Refer to table for full details):
- Repeatability:
- Low: Mean 69.9 mmol/L, SD 0.2 mmol/L, CV 0.3 %
- Med: Mean 174.5 mmol/L, SD 0.5 mmol/L, CV 0.3 %
- High: Mean 347.2 mmol/L, SD 0.9 mmol/L, CV 0.3 %
- Under Range Rerun: Low Mean 24.7 mmol/L, SD 0.2 mmol/L, CV 0.9 %; Med Mean 37.7 mmol/L, SD 0.2 mmol/L, CV 0.6 %; MDL Mean 31.7 mmol/L, SD 0.2 mmol/L, CV 0.7 %; High Mean 56.8 mmol/L, SD 0.4 mmol/L, CV 0.6 %
- Intermediate precision (CLSI):
- Low: Mean 69.9 mmol/L, SD 1.3 mmol/L, CV 1.8 %
- Med: Mean 174.5 mmol/L, SD 1.1 mmol/L, CV 0.7 %
- High: Mean 347.2 mmol/L, SD 2.8 mmol/L, CV 0.8 %
- Under Range Rerun: Low Mean 24.7 mmol/L, SD 0.9 mmol/L, CV 3.7 %; Med Mean 37.7 mmol/L, SD 1.0 mmol/L, CV 2.7 %; MDL Mean 31.7 mmol/L, SD 1.0 mmol/L, CV 3.0 %; High Mean 56.8 mmol/L, SD 1.1 mmol/L, CV 1.9 %
- Method Comparison to reference (flame photometer): N = 106, Days = 2, Correlation = 0.9995, Slope (Bablok) = 0.997, Intercept (Bablok) = 0.984, Range (X) = 69.2 - 337.4
- Method comparison to predicate: N = 92, Days = 2, Correlation = 0.9999, Slope (Bablok) = 1.021, Intercept (Bablok) = -4.562, Range (X) = 65.3 - 342.1
- Detection Limits: LOB = 8.1 mmol/L, LOD = 9.8 mmol/L, LOQ = 15.5 mmol/L
- Standard Measuring range: 60-350 mmol/L
- Under Range: 20-59.9 mmol/L via rerun with increase sample volume
Potassium (Refer to table for full details):
- Repeatability:
- Low: Mean 3.47 mmol/L, SD 0.01, CV 0.3
- Med: Mean 50.70 mmol/L, SD 0.26, CV 0.5
- High: Mean 93.48 mmol/L, SD 0.58, CV 0.6
- Intermediate precision (CLSI):
- Low: Mean 3.47 mmol/L, SD 0.04, CV 1.1
- Med: Mean 50.70 mmol/L, SD 0.63, CV 1.2
- High: Mean 93.48 mmol/L, SD 1.82, CV 1.9
- Method Comparison to reference (flame photometry): N = 99, Days = 2, Correlation = 0.9997, Slope (Bablok) = 1.014, Intercept (Bablok) = 0.507, Range (X) = 3.80 - 86.30
- Method comparison to predicate: N = 92, Days = 2, Correlation = 0.9998, Slope (Bablok) = 1.021, Intercept (Bablok) = -0.208, Range (X) = 4.87-96.94
- Detection Limits: LoB = 0.3 mmol/L, LoD = 0.4 mmol/L, LoQ = 1.1 mmol/L
- Reportable range: 3-100 mmol/L
- Extended Range: No Extended Range
Chloride (Refer to table for full details):
- Repeatability:
- Low: Mean 65.3 mmol/L, SD 0.3 mmol/L, CV 0.4 %
- Med: Mean 167.6 mmol/L, SD 0.5 mmol/L, CV 0.3 %
- High: Mean 333.5 mmol/L, SD 1.6 mmol/L, CV 0.5 %
- Under Range Rerun: Low Mean 21.6 mmol/L, SD 0.2 mmol/L, CV 1.0 %; Med Mean 34.2 mmol/L, SD 0.3 mmol/L, CV 0.9 %; MDL Mean 28.0 mmol/L, SD 0.2 mmol/L, CV 0.9 %; High Mean 55.0 mmol/L, SD 0.4 mmol/L, CV 0.8 %
- Intermediate precision (CLSI):
- Low: Mean 65.3 mmol/L, SD 0.9 mmol/L, CV 1.3 %
- Med: Mean 167.6 mmol/L, SD 1.1 mmol/L, CV 0.7 %
- High: Mean 333.5 mmol/L, SD 3.5 mmol/L, CV 1.0 %
- Under Range Rerun: Low Mean 21.6 mmol/L, SD 0.8 mmol/L, CV 3.7 %; Med Mean 34.2 mmol/L, SD 0.9 mmol/L, CV 2.5 %; MDL Mean 28.0 mmol/L, SD 0.8 mmol/L, CV 3.0 %; High Mean 55.0 mmol/L, SD 0.9 mmol/L, CV 1.7 %
- Method Comparison to reference (coulometry): N = 100, Days = 2, Correlation = 0.9995, Slope (Bablok) = 1.029, Intercept (Bablok) = -3.996, Range (X) = 66.0 - 287.0
- Method comparison to predicate: N = 92, Days = 2, Correlation = 0.9998, Slope (Bablok) = 1.023, Intercept (Bablok) = -3.284, Range (X) = 62.2 - 330.5
- Detection Limits: LOB = 7.8 mmol/L, LOD = 9.0 mmol/L, LOQ = 18.3 mmol/L
- Standard Measuring range: 60-350 mmol/L
- Under Range: 20-59.9 mmol/L
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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1
| Introduction | The information in this 510(k) summary is being submitted in accordance with requirements of 21 CFR 807.92. | |
|---|---|---|
| Submitter name, address, and contact | Roche Diagnostics | |
| 9115 Hague Road | ||
| Indianapolis, IN 46250 |
Contact person: David Tribbett
Phone: 317-521-2964
Fax: 317-521-2324
Date Prepared: May 8, 2014 | |
| Device name | Proprietary name: | cobas 8000 ISE Indirect Na, K, Cl for Gen. 2. |
| | Common name: | Sodium Test System
Potassium Test System
Chloride Test System |
| | Classification: | Ion-Specific Electrode Sodium
Ion-Specific Electrode Potassium
Ion-Specific Electrode Chloride |
| Establishment registration | For the cobas 8000 ISE module, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The establishment registration number for Roche Diagnostics, United States is 1823260. | |
| | Continued on next page | |
2
:
2
Classification The FDA has classified the Sodium, Potassium, and Chloride Test Systems as Class II devices.
| Panel | Code | Product Classification Name | Regulation |
|---|---|---|---|
| Clinical | IGS | Ion Specific Electrode, Sodium | 21 CFR |
| Chemistry (75) | 862.1665 | ||
| Clinical | CEM | Ion Specific Electrode. | 21 CFR |
| Chemistry (75) | Potassium | 862.1600 | |
| Clinical | CGZ | Ion Specific Electrode, Chloride | 21 CFR |
| Chemistry (75) | 862.1170 |
Draft labeling sufficient to describe the device, its intended use, and the Proposed labeling directions for use on the cobas 8000 ISE analyzer module for serum, plasma. and urine samples is included in the submission.
Device The cobas 8000 ISE module is an Ion-Selective Electrode (ISE) system for description the determination of sodium, potassium, and chloride in serum, plasma, and urine. The cobas 8000 ISE module and the ISE Gen 2 reagents were previously cleared for serum and plasma sample types under K100853 and urine sample type on K123726.
This premarket notification seeks to obtain FDA review and clearance for the urine sample type for the ISE Gen 2 reagents on the cobas 8000 ISE module using an expanded measuring range for sodium and chloride analytes at the low end of the measuring range and the new calibration method cleared in K132418.
An ISE makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution. The internal filling solution contains the test ion at a fixed concentration. Because of the particular nature of the membrane, the test jons will closely associate with the membrane on each side. The membrane EMF is determined by the difference in concentration of the test ion in the test solution and the internal filling solution. The EMF develops according to the Nernst equation for a specific ion in solution (see package insert for further explanation). Please refer to K 100853 for detailed hardware and software information relating to the cobas 8000 modular analyzer series.
Commercially available controls are recommended for the urine sample type. Aqueous ISE standards Low and High were cleared under K053165. The LHH calibration scheme was cleared under K132418.
3
| Intended use | The ISE module of the Roche/Hitachi cobas c system is intended for the
quantitative determination of sodium, potassium and chloride in serum,
plasma or urine using ion-selective electrodes. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The cobas 8000 ISE module is a fully automated ion-specific analyzer
intended for the in vitro potentiometric determination of chloride, potassium,
and sodium in serum, plasma, and urine using ion-selective electrodes.
Measurements obtained by this device are used in the diagnosis and treatment
of diseases or conditions involving electrolyte imbalance. |
| Substantial
equivalence -
comparison | The following tables compare the cobas 8000 ISE module using
Low/High/High calibration and its predicate device the cobas 8000 ISE
Module using Low/High/Serum Compensator calibration cleared under
K123726. |
Comparison of Systems similarities and differences
| System Comparison | ||
|---|---|---|
| Parameter | Predicate Device | |
| cobas 8000 ISE Module (K123726) | Candidate Device | |
| cobas 8000 ISE Module | ||
| Intended use | The ISE module of the Roche/Hitachi | |
| cobas c systems is intended for the | ||
| quantitative determination of sodium, | ||
| potassium and chloride in serum, plasma | ||
| or urine using ion-selective electrodes. | Same | |
| Specimen Type | Serum/Plasma/Urine | Same |
| Measurement | ||
| principle | ISE Potentiometry | Same |
| Reagent | ||
| container | Plastic bottles closed via screw caps | Same |
| Onboard storage | ||
| temperature | Room Temperature | Same |
| ISE Module | Separate ISE module connected to Core | |
| cobas 8000 module | Same | |
| Ion Selective | ||
| electrodes (ISEs) | Potentiometric chloride, potassium, | |
| sodium and reference electrodes | Same | |
| Sample Dilution | ||
| (Serum/plasma) | 1:31 | Same |
| Sample Dilution | ||
| (Urine) | 1:46 Standard Range | 1:46 Standard Range |
| 1:31 Under Range Rerun | ||
| Throughput | Max 1800 tests/hour | Same |
| Calibration | ||
| Scheme | ISE Standard Low, High, Serum | |
| Compensator | ||
| (LHSc) | ISE Standard Low, High, | |
| High | ||
| (LHH) |
4
| Comparison of
assays -
similarities and
differences | Assay Comparison
Sodium | | | | | | | | | | |
|--------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------|-----------|--|--|
| (Sodium) | Parameter | Predicate Device
cobas 8000 Urine ISE LHSC
Calibration Method (K123726) | | | | | Candidate Device
cobas 8000 Urine ISE LHH
Calibration Method | | | | |
| | Repeatability | | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | | |
| | | Low | 66.4 | 0.4 | 0.6 | Low | 69.9 | 0.2 | 0.3 | | |
| | | Med | 178.9 | 0.9 | 0.5 | Med | 174.5 | 0.5 | 0.3 | | |
| | | High | 321.7 | 0.7 | 0.2 | High | 347.2 | 0.9 | 0.3 | | |
| | | Liq 1 | 81.1 | 0.3 | 0.4 | Liq 1 | 83.4 | 0.3 | 0.3 | | |
| | | Liq 2 | 170.6 | 0.5 | 0.3 | Liq 2 | 175.6 | 1.3 | 0.8 | | |
| | | | | | | Under Range Rerun using increased sample: | | | | | |
| | | | | | | Low | 24.7 | 0.2 | 0.9 | | |
| | | | | | | Med | 37.7 | 0.2 | 0.6 | | |
| | | | | | | MDL | 31.7 | 0.2 | 0.7 | | |
| | | | | | | High | 56.8 | 0.4 | 0.6 | | |
| | | | | | | Liq 1
diluted | 42.1 | 0.3 | 0.6 | | |
| | | | | | | Liq 2
diluted | 32.2 | 0.3 | 0.8 | | |
| | Intermediate
precision
(CLSI) | | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | | |
| | | Low | 68.6 | 1.1 | 1.6 | Low | 69.9 | 1.3 | 1.8 | | |
| | | Med | 180.3 | 1.0 | 0.6 | Med | 174.5 | 1.1 | 0.7 | | |
| | | High | 318.0 | 2.1 | 0.7 | High | 347.2 | 2.8 | 0.8 | | |
| | | Liq 1 | 82.7 | 1.2 | 1.4 | Liq 1 | 83.4 | 1.3 | 1.6 | | |
| | | Liq 2 | 171.3 | 1.0 | 0.6 | Liq 2 | 175.6 | 1.7 | 1.0 | | |
| | | | | | | Under Range Rerun using increased sample: | | | | | |
| | | | | | | Low | 24.7 | 0.9 | 3.7 | | |
| | | | | | | Med | 37.7 | 1.0 | 2.7 | | |
| | | | | | | MDL | 31.7 | 1.0 | 3.0 | | |
| | | | | | | High | 56.8 | 1.1 | 1.9 | | |
| | | | | | | Liq 1
diluted | 42.1 | 1.0 | 2.5 | | |
| | | | | | | Liq 2
diluted | 32.2 | 1.0 | 3.9 | | |
| | Method
Comparison
to reference
(flame
photometer) | | N = 59
Days = 2
Correlation = 0.9997
Slope (Bablok) = 0.976
Intercept (Bablok) = 4.3548
Range (X) = 65.7 - 327.7 | | | N = 106
Days = 2
Correlation = 0.9995
Slope (Bablok) = 0.997
Intercept (Bablok) = 0.984
Range (X) = 69.2 - 337.4 | | | | | |
| | Method
comparison
to predicate | | N = 59
Days = 2
Correlation = 0.9996
Slope (Bablok) = 0.930
Intercept (Bablok) = 12.0671
Range (X) = 63.8 - 339.2 | | | N = 92
Days = 2
Correlation = 0.9999
Slope (Bablok) = 1.021
Intercept (Bablok) = -4.562
Range (X) = 65.3 - 342.1 | | | | | |
| | Detection
Limits | | LOB = 7.6 mmol/L
LOD = 8.9 mmol/L
LOQ = 23.2 mmol/L | | | LOB = 8.1 mmol/L
LOD = 9.8 mmol/L
LOQ = 15.5 mmol/L | | | | | |
| | Standard
Measuring
range | | 60-350 mmol/L | | | 60-350 mmol/L | | | | | |
| | Under Range | | No Extended Range | | | 20-59.9 mmol/L
via rerun with increase sample volume | | | | | |
5
| Comparison of
assays –
similarities and
differences
(Potassium) | Assay Comparison
Potassium | | |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Predicate Device
cobas 8000 Urine ISE LHSc
Calibration Method (K123726) | | Candidate Device
cobas 8000 Urine ISE LHH
Calibration Method |
| Repeatability | Mean [mmol/L]
SD [mmol/L]
CV [%] | | Mean [mmol/L]
SD [mmol/L]
CV [%] |
| | Low 3.65
0.00' 1.2 | Low | 3.47 0.01 0.3 |
| | Med 51.10
0.30 0.6 | Med | 50.70 0.26 0.5 |
| | High 83.78
0.66 0.8 | High | 93.48 0.58 0.6 |
| | Liq 1 32.19
019 0.6 | Liq 1 | 30.64 0.20 0.6 |
| | Liq 2 69.47
0.39 0.6 | Liq 2 | 66.22 0.61 0.9 |
| Intermediate
precision
(CLSI) | Mean [mmol/L]
SD [mmol/L]
CV [%] | | Mean [mmol/L]
SD [mmol/L]
CV [%] |
| | Low 3.75
0.06 1.7 | Low | 3.47 0.04 1.1 |
| | Med 49.48
0.65 1.3 | Med | 50.70 0.63 1.2 |
| | High 80.60
1.32 1.6 | High | 93.48 1.82 1.9 |
| | Liq I 31.32
0.37 1.2 | Liq 1 | 30.64 0.32 1.0 |
| | Liq 2 67.49
1.17 1.7 | Liq 2 | 66.22 1.14 1.7 |
| Method
Comparison
to reference
(flame
photometry) | N = 59
Days = 2
Correlation = 0.9993
Slope (Bablok) = 0.962
Intercept (Bablok) = 1.7605
Range (X) = 4.20 -91.90 | | N = 99
Days = 2
Correlation = 0.9997
Slope (Bablok) = 1.014
Intercept (Bablok) = 0.507
Range (X) = 3.80 - 86.30 |
| Method
comparison
to predicate | N = 59
Days = 2
Correlation = 0.9997
Slope (Bablok) = 0.920
Intercept (Bablok) = 1.4589
Range (X) = 3.98-97.74 | | N = 92
Days = 2
Correlation = 0.9998
Slope (Bablok) = 1.021
Intercept (Bablok) = -0.208
Range (X) = 4.87-96.94 |
| Detection
Limits | LoB = 0.3 mmol/L
LoD = 0.4 mmol/L
LoQ = 2.3 mmol/L | | LoB = 0.3 mmol/L
LoD = 0.4 mmol/L
LoQ = 1.1 mmol/L |
| Reportable
range | 3-100 mmol/L | | 3-100 mmol/L |
| Extended
Range | No Extended Range | | No Extended Range |
б
.
6
| | Parameter | Chloride
Predicate Device
cobas 8000 Urine ISE LHSc
Calibration Method (K123726) | | | Candidate Device
cobas 8000 Urine ISE LHH
Calibration Method | | |
|-------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|----------------------------------------------------------------------------------------------------------------------------------|----------------|-----------|
| Comparison of assays - similarities and differences
(Chloride) | Repeatability | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] |
| | Low | 63.6 | 0.5 | 0.7 | 65.3 | 0.3 | 0.4 |
| | Med | 180.8 | 0.9 | 0.5 | 167.6 | 0.5 | 0.3 |
| | High | 341.7 | 1.1 | 0.3 | 333.5 | 1.6 | 0.5 |
| | Liq 1 | 92.3 | 0.4 | 0.5 | 97.5 | 0.5 | 0.5 |
| | Liq 2 | 189.6 | 0.6 | 0.3 | 193.2 | 1.5 | 0.8 |
| | | Under Range Rerun using increased sample: | | | | | |
| | Low | | | | 21.6 | 0.2 | 1.0 |
| | Med | | | | 34.2 | 0.3 | 0.9 |
| | MDL | | | | 28.0 | 0.2 | 0.9 |
| | High | | | | 55.0 | 0.4 | 0.8 |
| | Liq 1 Diluted | | | | 43.7 | 0.3 | 0.7 |
| | Liq 2 Diluted | | | | 29.0 | 0.4 | 1.5 |
| | Intermediate precision (CLSI) | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] | Mean
[mmol/L] | SD
[mmol/L] | CV
[%] |
| | Low | 64.7 | 1.1 | 1.7 | 65.3 | 0.9 | 1.3 |
| | Med | 179.7 | 1.2 | 0.7 | 167.6 | 1.1 | 0.7 |
| | High | 336.5 | 3.5 | 1.0 | 333.5 | 3.5 | 1.0 |
| | Liq 1 | 92.6 | 1.1 | 1.2 | 97.5 | 0.9 | 0.9 |
| | Liq 2 | 187.6 | 1.6 | 0.9 | 193.2 | 2.0 | 1.0 |
| | | Under Range Rerun using increased sample: | | | | | |
| | Low | | | | 21.6 | 0.8 | 3.7 |
| | Med | | | | 34.2 | 0.9 | 2.5 |
| | MDL | | | | 28.0 | 0.8 | 3.0 |
| | High | | | | 55.0 | 0.9 | 1.7 |
| | Liq 1 Diluted | | | | 43.7 | 1.0 | 2.3 |
| | Liq 2 Diluted | | | | 29.0 | 0.9 | 3.2 |
| | Method Comparison to reference (coulometry) | N = 59
Days = 2
Correlation = 0.9985
Slope (Bablok) = 1.092
Intercept (Bablok) = -11.2893
Range (X) = 66.0 - 324.0 | | | N = 100
Days = 2
Correlation = 0.9995
Slope (Bablok) = 1.029
Intercept (Bablok) = -3.996
Range (X) = 66.0 - 287.0 | | |
| | Method comparison to predicate | N = 59
Days = 2
Correlation = 0.9997
Slope (Bablok) = 0.952
Intercept (Bablok) = 0.5078
Range (X) = 65.2 - 350.0 | | | N = 92
Days = 2
Correlation = 0.9998
Slope (Bablok) = 1.023
Intercept (Bablok) = -3.284
Range (X) = 62.2 - 330.5 | | |
| | Detection Limits | LOB = 8.7 mmol/L
LOD = 9.7 mmol/L
LOQ = 13.4 mmol/L | | | LOB = 7.8 mmol/L
LOD = 9.0 mmol/L
LOQ = 18.3 mmol/L | | |
| | Standard Measuring range | 60-350 mmol/L | | | 60-350 mmol/L | | |
| | Under Range | No Extended Range | | | 20-59.9 mmol/L | | |
:
7
| Evaluations
summary | The cobas 8000 ISE Module, Urine Sample Type was evaluated for several
performance characteristics, including repeatability, intermediate precision,
LoB, LoD, LoQ, method comparison, recovery in controls, and linearity. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The ISE Gen 2 reagents applied to the cobas 8000 ISE analyzer using LHH
calibration and increased sample rerun mode is substantially equivalent to the
predicate cobas 8000 ISE analyzer using LHSc calibration cleared under
K123726. |
8
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
ROCHE DIAGNOSTICS MR DAVID TRIBBETT REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K140373
Trade/Device Name: cobas 8000 ISE Indirect Na. K. Cl for Gen.2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ Dated: May 8, 2014 Received: May 12, 2014
Dear Mr. David Tribbett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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 (2) CFR Part 807): labeling (2) CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. David Tribbett
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140373
Device Name
cobas 8000 ISE Indirect Na, K. CI for Gen. 2
Indications for Use (Describe)
The cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentionetric determination of chloride, potassium, and sodium in serum, plasma, and urine ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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...
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
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