(130 days)
Not Found
No
The summary describes a standard laboratory electrode system for measuring carbon dioxide and does not mention any AI or ML components.
No
This device is for the quantitative determination of carbon dioxide in serum and plasma, used in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This indicates its role in identifying or characterizing a disease or condition.
No
The device description explicitly states it is comprised of electrodes, solutions, and calibrators, which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of carbon dioxide in serum and plasma." Serum and plasma are biological samples taken from the human body.
- Purpose: The intended use also states that these measurements "are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This clearly indicates the device is used for diagnostic purposes.
- Device Description: The device is described as an "electrode system" used with an analyzer, along with reagents (Reference Solution, Diluent, Calibrators). This is typical of in vitro diagnostic devices that analyze biological samples.
- Performance Studies: The document includes performance data like Method Comparison and Precision, which are standard for demonstrating the analytical performance of an IVD.
- Predicate Devices: The mention of predicate devices (K031879; ROCHE Diagnostics, COBAS Integra Bicarbonate liquid (CO2-L); Roche Diagnostics, Ammonia/Ethanol/CO2 calibrator) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for 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
- ISE Total CO2 Electrode
The Total CO2 electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of carbon dioxide in serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ISE CO2 electrode
The carbon dioxide electrode for the ELITech Clinical Systems Selectra ProM is intended for use for the quantitative in vitro diagnostic determination of Total CO2 in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), chloride (Cl-) and carbon dioxide (Total CO2) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
Product codes (comma separated list FDA assigned to the subject device)
KHS, JIX
Device Description
The ELITech Clinical Systems ISE Total CO2 Electrode system is comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.
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)
Method Comparison:
Total CO2
y = 0.908 x + 2.2 mEq/L
r= 0.985
range: 9.7 to 44.9 mEq/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Total CO2 :
Within run
Level 12.1 mEq/L CV=3.9%
Level 19.9 mEq/L CV=2.3%
Level 27.5 mEq/L CV=2.3%
Total
Level 12.1 mEq/L CV=6.8%
Level 19.9 mEq/L CV=5.4%
Level 27.5 mEq/L CV=5.2%
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
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
ELITech Vital Scientific BV Van Rensselaerweg 4, 6956 AV SPANKEREN, The Netherlands
.
NOV 18 2011
SECTION 5 - 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.
The assigned 510(k) number is: __________
| Submitter | ELITech Vital Scientific BV |
|---|---|
| Address | Van Rensselaerweg 4, 6956 AV SPANKEREN, The Netherlands |
| Phone number | + 31 (0) 313 430 501 |
| Fax number | + 33 (0) 313 427 807 |
Contact
Colinda van den Broek (Email: c.vandenbroek@elitechgroup.com)
Date of Preparation June 24, 2011
Device names
| Trade/proprietary Name: ELITech Clinical Systems ISE TotalCO₂ Electrode | |||||
|---|---|---|---|---|---|
| Common or Usual Name: Total CO₂ ISE | |||||
| Regulatory: | |||||
| Code | Name | Class | Regulation | Regulation Name | Panel |
| KHS | enzymatic, Carbon - Dioxide | II | 21 CFR 862.1160 | Bicarbonate/Carbon dioxide test | 75 Clinical Chemistry |
| Trade/proprietary Name:
Common or Usual Name:
Regulatory: | ELITech Clinical
ISE Calibrator |
|-----------------------------------------------------------------|------------------------------------|
Systems ISE Calibrators
| Code | Name | Class | Regulation | Regulation Name | Panel |
|---|---|---|---|---|---|
| JIX | calibrator, multi- | ||||
| analyte mixture | II | 21 CFR 862.1150 | Calibrator | 75 Clinical | |
| Chemistry |
Establishment Information:
The establishment registration number for ELITech Vital Scientific BV is 8030478.
The establishment registration number for ELITech SEPPIM SAS is 3007662974.
The establishment registration number for ELITech Wescor USA is 1717966.
The owner operator number for ELITech North America (Wescor, Logan, UT, USA) is 1717966.
Predicate device:
| Predicate Instrument or reagent | 510(k) Number | Product code(s) |
|---|---|---|
| • ROCHE Diagnostics, COBAS In- | ||
| tegra Bicarbonate liquid (CO2-L) | K031879 | KHS |
| • Roche Diagnostics, Ammo- | ||
| nia/Ethanol/CO2 calibrator |
1
| Substantial Equivalence: | The ELITech Clinical Systems ISE Total CO2 Electrode calibrated with
ELITech Clinical Systems ISE Calibrators is demonstrated to be substan-
tially equivalent to the Roche Diagnostics COBAS Integra Bicarbonate
liquid calibrated with Roche Diagnostics Ammonia/Ethanol/CO2 Calibrator |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The ELITech Clinical Systems ISE Total CO2 Electrode system is
comprised of the electrodes plus ISE Reference Solution, ISE Diluent,
ISE Calibrators. |
| Performance Standards | To date, no performance standards that affect this device have been
finalized under Section 514 of the Act. |
Intended Use
See Indications for Use following
Indications for Use:
- ISE Total CO2 Electrode
The Total CO2 electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of carbon dioxide in serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
2
Comparison to Predicate device
| Similarities and Differences | ||
|---|---|---|
| ISE MODULE | ELITech Clinical Systems Device | |
| (Selectra ProM ISE Module) | Predicate device | |
| (Selectra ProM ISE Module K102647) | ||
| Intended use/Indications for | ||
| Use | The Selectra ProM ISE module is an | |
| electrometer used for measurement | ||
| of electrolytes. | Same | |
| Intended use | used for the quantitative in vitro diag- | |
| nostic determination of sodium ( $Na^+$ ), | ||
| potassium ( $K^+$ ), chloride (Cl-) and total | ||
| CO2 in human serum and plasma | used for the quantitative in vitro diag- | |
| nostic determination of sodium ( $Na^+$ ), | ||
| potassium ( $K^+$ ), and chloride (Cl-) in | ||
| diluted serum, plasma and urine | ||
| Indication for Use | Sodium measurements are used in | |
| the diagnosis and treatment of aldos- | ||
| teronism (excessive secretion of the | ||
| hormone aldosterone), diabetes in- | ||
| sipidus (chronic excretion of large | ||
| amounts of dilute urine, accompanied | ||
| by extreme thirst), adrenal hyperten- | ||
| sion, Addison's disease (caused by | ||
| destruction of adrenal glands), dehy- | ||
| dration, inappropriate antidiuretic | ||
| hormone secretion, or other diseases | ||
| involving electrolyte imbalance | ||
| Potassium measurements are used to | ||
| monitor electrolyte balance in the | ||
| diagnosis and treatment of diseases | ||
| conditions characterized by low or | ||
| high blood potassium levels. | ||
| Chloride measurements are used in | ||
| the diagnosis and treatment of elec- | ||
| trolyte and metabolic disorders such | ||
| as cystic fibrosis and diabetic acido- | ||
| sis. | ||
| Bicarbonate/carbon dioxide meas- | ||
| urements are used in the diagnosis | ||
| and treatment of numerous potentially | ||
| serious disorders associated with | ||
| changes in body acid-base balance. | Sodium measurements are used in | |
| the diagnosis and treatment of aldos- | ||
| teronism (excessive secretion of the | ||
| hormone aldosterone), diabetes in- | ||
| sipidus (chronic excretion of large | ||
| amounts of dilute urine, accompanied | ||
| by extreme thirst), adrenal hyperten- | ||
| sion, Addison's disease (caused by | ||
| destruction of adrenal glands), dehy- | ||
| dration, inappropriate antidiuretic | ||
| hormone secretion, or other diseases | ||
| involving electrolyte imbalance | ||
| Potassium measurements are used to | ||
| monitor electrolyte balance in the | ||
| diagnosis and treatment of diseases | ||
| conditions characterized by low or | ||
| high blood potassium levels. | ||
| Chloride measurements are used in | ||
| the diagnosis and treatment of elec- | ||
| trolyte and metabolic disorders such | ||
| as cystic fibrosis and diabetic acido- | ||
| sis. | ||
| Test principle | ||
| Assay protocol | Indirect potentiometry measurement | |
| with Ion-Selective Electrode | Same | |
| Sample type | Serum or lithium heparinized plasma | |
| free of hemolysis, obtained anaerobi- | ||
| cally for total CO2. | Serum and hemolysis-free plasma. | |
| General information | ||
| Expected values | Sodium: | |
| Serum/plasma : 136-145 mmol/L | Same | |
| Potassium: | Same | |
| Serum: 3.5 -5.1 mmol/L | ||
| Plasma: 3.4 - 4.5 mmol/L | ||
| Chloride: | Same | |
| Serum/Plasma: 98 - 107 mmol/L | ||
| Method comparison | Sodium on serum | |
| Same | Sodium on serum | |
| Same | ||
| Potassium on serum | ||
| Same | Potassium on serum | |
| Same | ||
| Chloride on serum | ||
| Same | Chloride on serum | |
| Same | ||
| General information | ELITech Clinical Systems Device | |
| (Selectra ProM ISE Module) | Predicate device | |
| (ROCHE Diagnostics CO2-L, Bicar- | ||
| bonate liquid with Roche Diagnostics | ||
| Ammonia/Ethanol/CO2 Calibrator, | ||
| K031879) | ||
| Expected values | 23-29 mEq/L | 22-29 mEq/L |
| Reagent composition/technology | ISE reference including CO2 | |
| Composition: | ||
| Buffered solution with surfactant containing : | ||
| 1.75 of CO2 mmol/L | Reagent R1 : | |
| Composition: | ||
| Phosphoenolpyruvate ≥ 40 mmol/L | ||
| NADH analog ≥ 2.0 mmol/L | ||
| MDH (porcine) ≥ 314.3 µkat/L | ||
| PEPC (microbial) ≥ 30.8 µKat/L |
Liquid form, ready to use |
| | Storage:
Store at 10-30 °C. This solution is
stable until the expiry date stated on
the label. Do not freeze. | Storage:
Store at 2-8 °C. This solution is stable
until the expiry date stated on the
label. |
| Performance characteristics | | |
| Electrode slope range | Total CO2: - 40 to -10 mV | Not applicable |
| Measuring range | Total CO2: 10.8 - 43.0 mEq/L | 0.5-50 mmol/L |
| Precision | Total CO2 :
Within run
Level 12.1 mEq/L CV=3.9%
Level 19.9 mEq/L CV=2.3%
Level 27.5 mEq/L CV=2.3% | Within run
Level 18.7mmol/L CV=0.72%
Level 31.6 mmol/L CV=0.84%
Level 9.09 mmol/L CV=1.34%
Level 24.9 mmol/L CV=0.67% |
| | Total | Total |
| Level 12.1 mEq/L CV=6.8% | Level 18.2mmol/L CV=1.41% | |
| Level 19.9 mEq/L CV=5.4% | Level 31.2 mmol/L CV=0.81% | |
| Level 27.5 mEq/L CV=5.2% | Level 8.30 mmol/L CV=2.23% | |
| | Level 23.7 mmol/L CV=1.04% | |
| Method Comparison | | |
| | Total CO2 | |
| | $y=0.908 x + 2.2 mEq/L$ | $y=1.019x - 0.19 mmol/L$ |
| | r= 0.985 | r= 0.9995 |
| | range: 9.7 to 44.9 mEq/L | range: 2.46 to 46 mmol/L |
| Calibration Frequency | It is recommended to recalibrate after
setting-up of a new vial of ISE Refer-
ence Solution or of ISE Diluent then
every 4 hours when quality control
results fall outside the established
range, after replacing electrode, and
after ISE cleaning and maintenance. | Each lot and as required following
quality control procedures. |
| Controls | Recommended quality control mate-
rial (not included): | Recommended quality control mate-
rial: |
| | ELITech Clinical Systems ISE CON-
TROL I (Level 1) | Roche Diagnostics Precinorm U |
| | ELITech Clinical Systems ISE CON-
TROL II (level 2) | Roche Diagnostics Precipath U |
| Limitations | | |
| | Total CO2: | |
| | Unconjugated bilirubin: No signifi-
cant interference up to 30 mg/dL (513
μmol/L). | Icterus : No significant interference
up to 60 mg/dL for conjugated and
unconjugated bilirubin |
| | Conjugated bilirubin: No significant
interference up to 29.5 mg/dL (504
μmol/L). | Hemoglobin: No significant interfer-
ence up to an H index of 1000 (ap-
proximate haemoglobin concentration
1000 mg/dL). |
| | Hemoglobin : No significant interfer-
ence up to 300 mg/dL. | Lipemia: No significant interference
up to an L index of 2000. There is a
poor correlation between the L index |
| | Turbidity: No significant interference
up to 614 mg/dL (7 mmol/L). | (corresponds to turbidity) and triglyc-
erides concentration |
| | Acetylsalicylate: No significant inter-
ference up to 40 mg/dL (2.2 mmol/L).
Concentrations above the therapeutic
levels will interfere and cause errone-
ous results. | |
| | Ascorbic acid: No significant inter-
ference up to 16 mg/dL (0.9 mmol/L). | |
| | Concentrations above the therapeutic
levels will interfere and cause errone-
ous results. | |
| | Hyperlipemia or hyperproteinemia
lead to a negative bias in the meas-
urement of electrolyte because of
dilution effect. | |
| | | |
| ISE
CALIBRATORS | ELITech Clinical Systems Device
(ISE Calibrator) | Predicate device
(ROCHE Diagnostics CO2-L, Bicar-
bonate liquid with Roche Diagnostics
Ammonia/Ethanol/CO2 Calibrator,
K031879) |
| Traceability | According the following reference
material :
Na+ NIST SRM 919b
K+ NIST SRM 918b
Cl- NIST SRM 918b/919b
Total CO2 : NIST SRM 924a | This method has been standardized
against primary standard traceable to
NIST or NERL. |
| ISE Calibrators | Composition:
Aqueous solutions containing sodium,
potassium, chloride and total CO2 with
2 different levels of concentrations.
Concentrations are lot-specific. The
values are given in the vial labels. | Calibrator kit
Composition:
Aqueous buffer solution containing
ammonia, ethanol and sodium bicar-bonate with preservative. Liquid
ready-to-use calibrators
The concentrations of the calibrators
components have been adjusted to
ensure optimal calibration of the ap-
propriate Roche methods on clinical
chemistry analyzers. |
| | Storage:
Store at 2-30 °C. These calibrators
are stable until the expiry date stated
on the label. Do not freeze.
Stability: | Storage
Store at 2-8°C. These calibrators are
stable until the expiry date stated on
the label.
Stability : |
| | - Calibrators are stable until the expiry
date stated on the label.
- After opening, calibrators is stable
30 days when stored at 2-30 °C
Note: Calibrators should be immedi-
ately and tightly capped to prevent
contamination and evaporation. | - After opening, calibrators is stable 8
weeks when stored at 2-8 °C provided
that dispensing of the calibrator takes
place without microbial contamination,
e.g. by pouring out .
Note: Calibrators should be tightly
when not in use. |
3
.
·
4
5
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate devices in its intended use locations.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ELITechGroup Epoch Biosciences c/o Debra Hutson 21720 23ta Dr. SE Suite 150 Bothell, Washington 98021
NOV. 1 8 2011
K111960 Re:
Trade Name: ELITech Clinical Systems ISE CO2 Electrode, ELITech Clinical Systems ISE CALIBRATORS Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Codes: KHS, JIX Dated: November 14, 2011 Received: November 15, 2011
Dear Ms. Hutson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use Form
510(k) Number (if known): _K | | | 9 6 O
ELITech Clinical Systems ISE CO2 Electrode Device Name:
Indications for Use:
ISE CO2 electrode
The carbon dioxide electrode for the ELITech Clinical Systems Selectra ProM is intended for use for the quantitative in vitro diagnostic determination of Total CO2 in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rutl. Cholen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
111960 510(k) =
Page 1 of 2
9
Indications for Use Form
111960 510(k) Number (if known):
ELITech Clinical Systems ISE CALIBRATORS Device Name:
Indications for Use:
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), chloride (Cl-) and carbon dioxide (Total CO2) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
approvide and commended and real province to responsible to the responsive management model many a comments of the comments of the comments of the comments of the comments of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruth Cheshir
.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 111960
Page Lof _2