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.
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.

Device Description

The ELITech Clinical Systems ISE Total CO2 Electrode system is comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ELITech Clinical Systems ISE TotalCO2 Electrode and ISE Calibrators, based on the provided text:

Key Takeaway: This document is a 510(k) summary for a medical device (Total CO2 electrode and calibrators). It focuses on demonstrating substantial equivalence to a previously approved predicate device, not on validating novel performance claims. As such, the "acceptance criteria" and "study" described are primarily for demonstrating equivalence, especially concerning analytical performance (precision and method comparison). Given this is a 510(k), it is an analytical study, not a clinical study to diagnose disease.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparison to the predicate device, aiming to show performance that is either equivalent or better. Specific acceptance criteria are not explicitly stated in a quantitative form, but rather the performance data is presented for comparison.

Performance Characteristic	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ELITech Clinical Systems)	Predicate Device Performance (Roche Diagnostics)
Measuring Range (Total CO2)	To be comparable to predicate (0.5-50 mmol/L)	10.8 - 43.0 mEq/L	0.5-50 mmol/L
Precision (Total CO2)	To be comparable to predicate	Within run:	Within run:
		L1 (12.1 mEq/L): CV=3.9%	L1 (18.7mmol/L): CV=0.72%
		L2 (19.9 mEq/L): CV=2.3%	L2 (31.6 mmol/L): CV=0.84%
		L3 (27.5 mEq/L): CV=2.3%	L3 (9.09 mmol/L): CV=1.34%
		Total:	L4 (24.9 mmol/L): CV=0.67%
		L1 (12.1 mEq/L): CV=6.8%	Total:
		L2 (19.9 mEq/L): CV=5.4%	L1 (18.2mmol/L): CV=1.41%
		L3 (27.5 mEq/L): CV=5.2%	L2 (31.2 mmol/L): CV=0.81%
			L3 (8.30 mmol/L): CV=2.23%
			L4 (23.7 mmol/L): CV=1.04%
Method Comparison (Total CO2)	Correlation (r) and slope (y=mx+b) comparable to predicate	$y=0.908x + 2.2 mEq/L$, r=0.985, range: 9.7 to 44.9 mEq/L	$y=1.019x - 0.19 mmol/L$, r=0.9995, range: 2.46 to 46 mmol/L
Interferences (Total CO2)	No significant interference within specified limits comparable to predicate	Unconjugated bilirubin: No significant 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 interference up to 300 mg/dL.	Hemoglobin: No significant interference up to an H index of 1000 (approximate haemoglobin concentration 1000 mg/dL).
		Turbidity: No significant interference up to 614 mg/dL (7 mmol/L).	Lipemia: No significant interference up to an L index of 2000.
		Acetylsalicylate: No significant interference up to 40 mg/dL (2.2 mmol/L). Concentrations above therapeutic levels will interfere.
		Ascorbic acid: No significant interference up to 16 mg/dL (0.9 mmol/L). Concentrations above therapeutic levels will interfere.
		Hyperlipemia/hyperproteinemia lead to negative bias.

Study Information

Sample Size used for the test set and the data provenance:
- Total CO2 Method Comparison: The range for the method comparison was 9.7 to 44.9 mEq/L. The document does not explicitly state the number of samples used for the method comparison study.
- Precision Study: For the precision study, results are reported for multiple "levels" (12.1 mEq/L, 19.9 mEq/L, 27.5 mEq/L). The number of replicates at each level is not specified, but typically "within-run" and "total" precision studies involve multiple measurements over several days.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission, these are typically prospective analytical studies performed by the manufacturer, but this is not explicitly confirmed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an analytical performance study for an in vitro diagnostic device, not a clinical diagnostic study involving image interpretation or expert consensus. Therefore, there were no "experts" in the sense of clinical specialists establishing a ground truth for diagnostically challenging cases.
- The "ground truth" or reference values for method comparison would have been established by the predicate device (Roche Bicarbonate liquid) or a recognized reference method commonly used in clinical chemistry labs. The comparison data shows a linear regression against the predicate, implying the predicate served as the reference for comparative analysis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, this is an analytical performance study, not a clinical study requiring adjudication of diagnostic outcomes.
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:
- Not applicable. This is not an AI/imaging device and does not involve human readers for interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics (precision, method comparison, measuring range, interferences) are all for the standalone device (ELITech Clinical Systems ISE Total CO2 Electrode) without human intervention in the result generation process, beyond operating the instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche Diagnostics COBAS Integra Bicarbonate liquid) or a recognized clinical chemistry reference method, against which the new device's measurements are compared. The calibrators are traceable to NIST SRM (National Institute of Standards and Technology Standard Reference Materials), which serves as a metrological ground truth for concentration.
The sample size for the training set:
- This document describes performance validation studies, not product development or machine learning training. There is no mention of a "training set" in the context of machine learning model development. This is a traditional IVD device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.

Summary

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ELITech Vital Scientific BV Van Rensselaerweg 4, 6956 AV SPANKEREN, The Netherlands

NOV 18 2011

K111960

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 ClinicalISE Calibrator

Systems ISE Calibrators

Code	Name	Class	Regulation	Regulation Name	Panel
JIX	calibrator, multi-analyte mixture	II	21 CFR 862.1150	Calibrator	75 ClinicalChemistry

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

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Substantial Equivalence:	The ELITech Clinical Systems ISE Total CO2 Electrode calibrated withELITech Clinical Systems ISE Calibrators is demonstrated to be substan-tially equivalent to the Roche Diagnostics COBAS Integra Bicarbonateliquid calibrated with Roche Diagnostics Ammonia/Ethanol/CO2 Calibrator
Device description	The ELITech Clinical Systems ISE Total CO2 Electrode system iscomprised of the electrodes plus ISE Reference Solution, ISE Diluent,ISE Calibrators.
Performance Standards	To date, no performance standards that affect this device have beenfinalized 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.

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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 forUse	The Selectra ProM ISE module is anelectrometer used for measurementof electrolytes.	Same
Intended use	used for the quantitative in vitro diag-nostic determination of sodium ( $Na^+$ ),potassium ( $K^+$ ), chloride (Cl-) and totalCO2 in human serum and plasma	used for the quantitative in vitro diag-nostic determination of sodium ( $Na^+$ ),potassium ( $K^+$ ), and chloride (Cl-) indiluted serum, plasma and urine
Indication for Use	Sodium measurements are used inthe diagnosis and treatment of aldos-teronism (excessive secretion of thehormone aldosterone), diabetes in-sipidus (chronic excretion of largeamounts of dilute urine, accompaniedby extreme thirst), adrenal hyperten-sion, Addison's disease (caused bydestruction of adrenal glands), dehy-dration, inappropriate antidiuretichormone secretion, or other diseasesinvolving electrolyte imbalancePotassium measurements are used tomonitor electrolyte balance in thediagnosis and treatment of diseasesconditions characterized by low orhigh blood potassium levels.Chloride measurements are used inthe diagnosis and treatment of elec-trolyte and metabolic disorders suchas cystic fibrosis and diabetic acido-sis.Bicarbonate/carbon dioxide meas-urements are used in the diagnosisand treatment of numerous potentiallyserious disorders associated withchanges in body acid-base balance.	Sodium measurements are used inthe diagnosis and treatment of aldos-teronism (excessive secretion of thehormone aldosterone), diabetes in-sipidus (chronic excretion of largeamounts of dilute urine, accompaniedby extreme thirst), adrenal hyperten-sion, Addison's disease (caused bydestruction of adrenal glands), dehy-dration, inappropriate antidiuretichormone secretion, or other diseasesinvolving electrolyte imbalancePotassium measurements are used tomonitor electrolyte balance in thediagnosis and treatment of diseasesconditions characterized by low orhigh blood potassium levels.Chloride measurements are used inthe diagnosis and treatment of elec-trolyte and metabolic disorders suchas cystic fibrosis and diabetic acido-sis.
Test principle
Assay protocol	Indirect potentiometry measurementwith Ion-Selective Electrode	Same
Sample type	Serum or lithium heparinized plasmafree 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 serumSame	Sodium on serumSame
	Potassium on serumSame	Potassium on serumSame
	Chloride on serumSame	Chloride on serumSame
General information	ELITech Clinical Systems Device(Selectra ProM ISE Module)	Predicate device(ROCHE Diagnostics CO2-L, Bicar-bonate liquid with Roche DiagnosticsAmmonia/Ethanol/CO2 Calibrator,K031879)
Expected values	23-29 mEq/L	22-29 mEq/L
Reagent composition/technology	ISE reference including CO2Composition:Buffered solution with surfactant containing :1.75 of CO2 mmol/L	Reagent R1 :Composition:Phosphoenolpyruvate ≥ 40 mmol/LNADH analog ≥ 2.0 mmol/LMDH (porcine) ≥ 314.3 µkat/LPEPC (microbial) ≥ 30.8 µKat/LLiquid form, ready to use
	Storage:Store at 10-30 °C. This solution isstable until the expiry date stated onthe label. Do not freeze.	Storage:Store at 2-8 °C. This solution is stableuntil the expiry date stated on thelabel.
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 runLevel 12.1 mEq/L CV=3.9%Level 19.9 mEq/L CV=2.3%Level 27.5 mEq/L CV=2.3%	Within runLevel 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 aftersetting-up of a new vial of ISE Refer-ence Solution or of ISE Diluent thenevery 4 hours when quality controlresults fall outside the establishedrange, after replacing electrode, andafter ISE cleaning and maintenance.	Each lot and as required followingquality 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 (513μmol/L).	Icterus : No significant interferenceup to 60 mg/dL for conjugated andunconjugated bilirubin
	Conjugated bilirubin: No significantinterference up to 29.5 mg/dL (504μmol/L).	Hemoglobin: No significant interfer-ence up to an H index of 1000 (ap-proximate haemoglobin concentration1000 mg/dL).
	Hemoglobin : No significant interfer-ence up to 300 mg/dL.	Lipemia: No significant interferenceup to an L index of 2000. There is apoor correlation between the L index
	Turbidity: No significant interferenceup 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 therapeuticlevels 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 therapeuticlevels will interfere and cause errone-ous results.
	Hyperlipemia or hyperproteinemialead to a negative bias in the meas-urement of electrolyte because ofdilution effect.

ISECALIBRATORS	ELITech Clinical Systems Device(ISE Calibrator)	Predicate device(ROCHE Diagnostics CO2-L, Bicar-bonate liquid with Roche DiagnosticsAmmonia/Ethanol/CO2 Calibrator,K031879)
Traceability	According the following referencematerial :Na+ NIST SRM 919bK+ NIST SRM 918bCl- NIST SRM 918b/919bTotal CO2 : NIST SRM 924a	This method has been standardizedagainst primary standard traceable toNIST or NERL.
ISE Calibrators	Composition:Aqueous solutions containing sodium,potassium, chloride and total CO2 with2 different levels of concentrations.Concentrations are lot-specific. Thevalues are given in the vial labels.	Calibrator kitComposition:Aqueous buffer solution containingammonia, ethanol and sodium bicar-bonate with preservative. Liquidready-to-use calibratorsThe concentrations of the calibratorscomponents have been adjusted toensure optimal calibration of the ap-propriate Roche methods on clinicalchemistry analyzers.
	Storage:Store at 2-30 °C. These calibratorsare stable until the expiry date statedon the label. Do not freeze.Stability:	StorageStore at 2-8°C. These calibrators arestable until the expiry date stated onthe label.Stability :
	- Calibrators are stable until the expirydate stated on the label.- After opening, calibrators is stable30 days when stored at 2-30 °CNote: Calibrators should be immedi-ately and tightly capped to preventcontamination and evaporation.	- After opening, calibrators is stable 8weeks when stored at 2-8 °C providedthat dispensing of the calibrator takesplace without microbial contamination,e.g. by pouring out .Note: Calibrators should be tightlywhen not in use.

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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.

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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).

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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

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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

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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

Regulation Number and Section

§ 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.