The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Device Description

Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.

However, based on the analytical performance studies described, we can extract the following information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).

Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be <= X") are not explicitly stated as separate criteria but are implied by the reported results indicating successful testing.

Table of Acceptance Criteria (Implied by Reported Performance) and Reported Device Performance

Performance Metric	Implied Acceptance Criterion (from reported performance meeting "non-clinical testing")	Reported Device Performance
Precision
Within-Laboratory Precision (Total SD) - pH ~6.3 (Sample A)	$\le$ 0.0922 pH units (or lower)*	0.0922 pH units
Within-Laboratory Precision (Total %CV) - pH ~6.3 (Sample A)	$\le$ 1.46% (or lower)*	1.46%
Within-Laboratory Precision (Total SD) - pH ~7.85 (Sample B)	$\le$ 0.1650 pH units (or lower)*	0.1650 pH units
Within-Laboratory Precision (Total %CV) - pH ~7.85 (Sample B)	$\le$ 2.10% (or lower)*	2.10%
Linearity (Peritoneal Drain Fluid)
Max Deviation from Linearity (Overall pH 5-9)	$\le$ 0.1446 pH units (or lower)*	0.1446 pH units
Max Deviation from Linearity (pH 5-6)	$\le$ 0.1446 pH units (or lower)*	0.1446 pH units
Max Deviation from Linearity (pH 6-7)	$\ge$ -0.0011 pH units (or higher)*	-0.0011 pH units
Max Deviation from Linearity (pH 7-8)	$\ge$ -0.0102 pH units (or higher)*	-0.0102 pH units
Max Deviation from Linearity (pH 8-9)	$\le$ 0.1129 pH units (or lower)*	0.1129 pH units
Linearity (NIST Traceable pH Buffer Solutions)
Max Deviation from Linearity (pH 4-10)	$\le$ 0.1 pH units (or lower)*	0.1 pH units
Interference	No significant source of interference reported	No significant source of interference determined
Method Comparison (Mean Bias)
Mean Bias (pH 5-6)	Within [-0.263, -0.177] pH units*	-0.223 pH units
Mean Bias (pH 6-7)	Within [-0.298, -0.207] pH units*	-0.251 pH units
Mean Bias (pH 7-8)	Within [-0.177, -0.022] pH units*	-0.102 pH units
Mean Bias (pH 8-9)	Within [-0.155, -0.052] pH units*	-0.105 pH units

Note: The acceptance criteria are "implied" because the document states "Performance testing demonstrates equivalence" and presents these results. It is assumed that these reported values either met or fell within the pre-defined acceptance limits set by the manufacturer for non-clinical analytical performance. The document doesn't explicitly state the thresholds for acceptance, but rather the results that were found acceptable for clearance.

Study Proof of Device Meeting Acceptance Criteria (Non-Clinical Analytical Performance)

The device demonstrates it meets its non-clinical analytical requirements through several studies:

2. Sample Sizes Used for the Test Set and Data Provenance:

Precision Study:
- Sample Size: 16 devices x 5 days x 3 runs x 12 replicates = 2880 measurements (total for each pH level, so 5760 samples for both pH levels combined).
- Data Provenance: Single site study, using buffered and spiked donor human peritoneal drainage fluid. Origin of fluid (e.g., country) is not specified, nor is whether it's retrospective or prospective collection (though likely prospective for a controlled lab study).
Linearity Study (Peritoneal Drain Fluid):
- Sample Size: Not explicitly stated as a single number, but mentions "peritoneal drain fluid samples collected in the Method Comparison study".
- Data Provenance: Donor human peritoneal drain fluid samples. Origin not specified.
Linearity Study (NIST Traceable pH Buffer Solutions):
- Sample Size: Not explicitly stated.
- Data Provenance: NIST traceable pH buffer solutions.
Interference Study:
- Sample Size: 2 pH levels x 16 paired observations per pH level = 32 paired observations per interferent. Number of interferents is 16. Total observations are 32 * 16 = 512.
- Data Provenance: Simulated peritoneal fluids.
Comparison Studies (Method Comparison):
- Sample Size: 60 donor human peritoneal drain fluid samples.
- Data Provenance: Donor human peritoneal drain fluid samples by a "glass pH probe" as the comparator. Origin not specified.

All these studies appear to be retrospective lab-based analytical studies on collected samples rather than prospective human clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not applicable/not provided in the context of the described non-clinical analytical performance studies. The "ground truth" for pH measurements in these studies was established by:
- Known concentrations of buffered solutions.
- Measurements from a reference method (e.g., "glass pH probe" as a comparator in the method comparison study).
- Spiked samples with known concentrations of interferents.
- For the linearity study using NIST traceable pH buffer solutions, the NIST standard itself serves as the ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Adjudication by human experts is typically performed in clinical studies involving interpretation (e.g., imaging diagnostics). For analytical performance, the ground truth is established by the reference method or known properties of the samples, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The provided document describes non-clinical analytical performance studies, not studies involving human readers or comparative effectiveness with or without AI assistance. The device is a "blood gases (PCO2, PO2) and blood pH test system" that measures pH, not an AI-based diagnostic tool for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, in essence, the described "Analytical Performance" studies evaluate the device's standalone performance. The Origin™ system (device and app) independently measures pH. The precision, linearity, interference, and method comparison studies assess its direct measurement capabilities without human interpretation or intervention in the measurement process itself, beyond standard laboratory handling. It's a continuous pH monitoring device, and its accuracy is evaluated against known values or reference methods.

7. The Type of Ground Truth Used:

Analytical/Reference Ground Truth:
- For precision and linearity studies using buffered solutions: Known pH values of the buffers, or measurements by a calibrated reference instrument (like the "glass pH probe" mentioned).
- For linearity using NIST traceable pH buffer solutions: The certified pH values of the NIST traceable buffers.
- For interference study: Known concentrations of spiked interferents in simulated peritoneal fluids.
- For method comparison: Measurements obtained from a "glass pH probe" on donor human peritoneal drain fluid samples served as the comparator/reference.

8. The Sample Size for the Training Set:

The document does not explicitly describe a "training set" in the context of machine learning or deep learning models for an AI device. The Origin™ system measures pH using a "potentiometric measurement pH" principle with an "Ion-sensitive field-effect transistor (ISFET) electrode". This suggests a sensor-based measurement rather than a machine learning algorithm that requires a "training set" in the typical sense.
The closest concept would be the data used for the internal development and calibration of the device's measurement algorithm, but this is not detailed in terms of a specific "training set size" in this submission.

9. How the Ground Truth for the Training Set Was Established:

As above, the concept of a "training set" ground truth is not applicable to the type of device described. The device is a direct pH measurement system, not an AI-interpretive device trained on labeled data. Its "ground truth" for functionality and calibration during development would be established through standard analytical chemistry principles, using reference buffers and comparison to established methods or instruments.

Summary

FDA 510(k) Clearance Letter - Origin™ System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 21, 2025

NERv Technology Inc. D.B.A. FluidAI Medical
Mariam Al-Lami
QA/RA Manager
809 Wellington Street North
Unit 2
Kitchener, ON N2H 5L6
Canada

Re: K243965
Trade/Device Name: Origin™
Regulation Number: 21 CFR 862.1120
Regulation Name: Blood Gases (PCO2, PO2) And Blood pH Test System
Regulatory Class: Class II
Product Code: SFO
Dated: July 22, 2025
Received: July 22, 2025

Dear Mariam Al-Lami:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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K243965 - Mariam Al-Lami Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K243965 - Mariam Al-Lami Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D.
Deputy Director
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243965
Device Name: Origin™

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
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PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary Document

1. Submitter Information:

Applicant
NERv Technology Inc. D.B.A FluidAI Medical
Unit 2, 809 Wellington St. N.,
Kitchener, ON, N2H 5L6, Canada

Applicant Contact
Mariam Al-Lami, QA/RA Manager
Phone: +1 (519) 722-3438
Email: mariam@fluidai.md

Date of Summary Preparation: Aug 21, 2025
510(k) Submission Number: K243965

2. Device Information:

Trade Name of the Device: Origin™
Common Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood pH
Product Code: SFO
Regulation Number: 862.1120

3. Device Description:

4. Indications for Use:

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5. Comparison of Technological Characteristics to Predicate

The following table summarizes the technological characteristics of the subject and predicate device. The devices have the same general intended use, and while there are differences in technological characteristics these differences do not raise new questions of safety and efficacy. Performance testing demonstrates equivalence between the subject and predicate device.

	Subject device	Predicate device
Device name	Origin™	ABL835 Flex Analyzer
Regulation number	862.1120	862.1120
Product classification	SFO	CHL
Intended Use	The measurement of pH in bodily fluids	Same
Indications for use	The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.	The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
pH measurement principle	Potentiometric measurement pH	Same
pH Electrode	Ion-sensitive field-effect transistor (ISFET)	glass ion-sensitive electrode (ISE)
Reference Electrode	Ag/AgCl	Same
Calibration method	1-point liquid calibration	2-point liquid calibration
QC solutions	Discrete syringes	Discrete bottles and ampoules
Measurement range	5-9 pH	7-7.5 pH
Sample type	Drain effluent	pleural fluid or blood
Sample application	continuous	discrete
Sample volume	N/A - continuous measurements	>=85uL
Sampling technique	Directly measures drain effluent continuously from patient	Point measurements of a patient sample of pleural fluid or whole blood
Resolution of display	0.01 pH	0.001 pH
Power Supply	Battery powered	Wall powered
Measurement Setting	Point of Care	Laboratory
Data Display	Mobile Device and Application	Built in the instrument
Measurement Temperature Range	18-40 °C	37 °C

6. Summary of Non-Clinical Testing:

1. Analytical Performance

a. Precision

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The precision of Origin™ was evaluated with a study conducted at a single site using two continuous test setups circulating buffered and spiked donor human peritoneal drainage fluid at two pH levels (~6.3 and ~7.7), simulating 33% and 66% of the device's measuring range. In the precision study, the following were evaluated: within-run (repeatability), between-run, between-day, between-device, and within-laboratory precision (total). The study was done using 16 devices x 5 days x 3 runs x 12 replicates (n=2880). Table 1 summarizes the precision study results for repeatability and within-lab precision.

Table 1: Origin™ precision study results.

Sample	N	Mean Value	Repeatability		Between-Run		Between-Day		Between-Device		Within-Laboratory
			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
A	1440	6.303	0.0154	0.24%	0.0384	0.61%	0.0758	1.20%	0.0323	0.51%	0.0922	1.46%
B	1440	7.854	0.0190	0.24%	0.1426	1.82%	0.0809	1.03%	0.0000	0.00%	0.1650	2.10%

b. Linearity

The linear measuring range for Origin™ was evaluated using peritoneal drain fluid samples collected in the Method Comparison study (see section 6.1.d below). Table 1 summarizes the linearity study results.

Table 1: Origin™ linearity results.

pH range	Maximum Deviation from Linearity [pH units]
Overall (pH 5 to 9)	0.1446
pH 5 to 6	0.1446
pH 6 to 7	-0.0011
pH 7 to 8	-0.0102
pH 8 to 9	0.1129

An additional linearity study, using NIST traceable pH buffer solutions in the range of pH 4-10, was conducted. Table 3:2 Origin™ linearity results with pH buffer solutions. summarizes the linearity study results.

Table 3:2 Origin™ linearity results with pH buffer solutions.

Specification	Maximum Deviation from Linearity across pH 4 – 10 [pH units]
Linearity	0.1

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c. Interference

Origin™ was tested against commonly encountered interferent substances. In this study, the effect of each interferent (at clinically relevant concentrations) on the pH measurements of Origin™ was measured through a paired difference test. This test occurred across two pH levels within the intended use range (pH 7 – Low and pH 8 – High) using simulated peritoneal fluids. The study produced one set of 16 paired observations per pH level (2 pH x n=16) for each interferent. No significant source of interference was determined from the testing of spiked simulated peritoneal fluids. The concentration of each of the tested interferent is listed in Table 4.

Table 4: Origin™ tested interference concentrations.

Interferent	Concentration (mg/dL, base mass)	Interferent Type
Bilirubin	60	Endogenous
Triglycerides	1667	Endogenous
Creatinine	75	Endogenous
Albumin (or total protein)	5300	Endogenous
Uric acid	31.2	Endogenous
Glucose	1000	Endogenous
Hemoglobin	1000	Endogenous
Morphine	0.78	Exogenous
Acetaminophen	7.8	Exogenous
Ibuprofen	36	Exogenous
Celecoxib	2.4	Exogenous
Ondansetron	0.0342	Exogenous
Cefoxitin	92.7	Exogenous
Metronidazole	12.3	Exogenous
Bupivacaine	1.05	Exogenous
Heparin	330 units/dL	Exogenous

d. Comparison Studies

Origin™ was compared against a glass pH probe in measuring 60 donor human peritoneal drain fluid samples. The study was conducted in 2 consecutive sets where each set was conducted over 6 days with 8 Origin™ devices compared to 4 glass pH probes. The measurements were done at the end of a 24-hour calibration period for Origin™ and represent the worst-case scenario bias. Table 5 summarizes the method comparison results. Figure 1: Scatterplot of subject vs comparator pH measurements shows a scatterplot of the subject vs comparator pH measurements.

Table 5: Origin™ method comparison Results

pH range	Slope [95% CI]	Intercept [95% CI]	r²	Mean bias [95% CI]
5-6	0.961 [0.770, 1.151]	-0.001 [-1.073, 1.071]	0.944	-0.223 [-0.263, -0.177]
6-7	0.936 [0.761, 1.112]	0.167 [-0.983, 1.318]	0.875	-0.251 [-0.298, -0.207]
7-8	1.369 [1.161, 1.578]	-2.899 [-4.482, -1.316]	0.839	-0.102 [-0.177, -0.022]
8-9	1.217 [0.914, 1.520]	-1.892 [-4.391, 0.606]	0.576	-0.105 [-0.155, -0.052]

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Figure 1: Scatterplot of subject vs comparator pH measurements

2. Functional Systems Testing

Functional systems testing was done to show that the device met all requirements.

3. Standards Compliance

The Origin™ system is designed and tested to be compliant with the following standards:

IEC 62304:2006/AMD 1:2015 Medical device software – Software life cycle processes
IEC 60601-1:2005 AMD1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 AMD1:2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 61010-1:2010/AMD1:2016 – Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
IEC 61326-2-6 Edition 3.0 2020-10: Electrical equipment for measurement control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

The following standard/guidance documents are referenced:

CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition
CLSI EP06 Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition
CLSI EP07 Interference Testing in Clinical Chemistry, 3rd Edition
CLSI EP09c Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition
CLSI EP37 Supplemental Tables for Interference Testing in Clinical Chemistry, 1st Edition
CLSI EP39 A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition

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7. Conclusion

Based on the information presented in this submission it can be concluded that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.