The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, Potassium, and Chloride in heparinized venous whole blood, plasma and serum.

Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Description

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.

The two options for the sensor card are:

. Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed ● analytes: pH, Hct, Na, K, CI, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure sodium, potassium, and chloride.

The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).

Calibration standards are provided in sealed pouches within a callbrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

AI/ML Overview

This document describes the premarket notification for the Stat Profile Prime ES Comp Plus Analyzer System, a medical device for in vitro diagnostic use. It outlines the device's intended use, performance testing, and the conclusion that it is substantially equivalent to a predicate device.

Here's an analysis of the provided text, broken down by your requested categories:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it states that "Performance testing was completed to demonstrate that the Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent in performance, safety and efficacy to the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer (K110648)."

The performance tests conducted include:

Method Comparison Studies
Precision/Reproducibility Studies
Run to Run Precision
Linearity Testing
Specificity / Interference Testing
Detection Limit
Shelf Life Stability Testing

The reported device performance, in relation to these tests, is a general conclusion: "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)."

Without specific numerical acceptance criteria (e.g., minimum accuracy, maximum bias, %CV for precision), a direct table comparison with specific values is not possible from the provided text. The acceptance criteria are implicitly that the new device's performance metrics (accuracy, precision, linearity, etc.) met or exceeded those of the predicate device, or fell within clinically acceptable ranges for such devices. The reported device performance is simply that it met these implicit criteria by demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the performance tests (Method Comparison, Precision, Linearity, etc.).

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for the test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The device is an in vitro diagnostic blood analyzer, and its ground truth would typically be established by reference methods or other validated laboratory instruments, not by expert consensus in the way an imaging AI might.

4. Adjudication method for the test set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or expert consensus to resolve discrepancies, particularly for subjective assessments. This document describes an objective measurement device for chemical analytes, where "ground truth" is typically established instrumentally through reference methods, not through human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, the studies described are essentially standalone performance evaluations of the device. The "Stat Profile Prime ES Comp Plus Analyzer System" is an automated instrument that measures analytes. The performance tests (Method Comparison, Precision, Linearity, etc.) evaluate the device's output (measurements of Na+, K+, Cl-) against either reference methods or expected values, without human interpretive input affecting the measurement itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the specific type of ground truth used for each test. However, for in vitro diagnostic devices like this, the ground truth for performance studies is typically established by:

Reference methods: For method comparison studies, the device's measurements are compared against a recognized, often more laborious or expensive, reference measurement method or a well-established, previously validated clinical laboratory analyzer (the predicate device, in this case).
Known concentrations: For linearity and detection limit studies, samples with precisely known concentrations of the analytes (e.g., prepared standards) are used as ground truth.
Internal quality control materials: For precision and run-to-run variation, the consistency of measurements on stable, characterized quality control materials acts as a ground truth for reproducibility.

Given the context, the ground truth would be based on analytical reference methods or established comparator devices/standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This device is an analyzer that utilizes established ion-selective electrode technology and measurement algorithms. It's unlikely to have a "training set" in the sense of machine learning/AI models. The algorithms are based on electrochemical principles, not data-driven learning that requires a distinct training phase.

9. How the ground truth for the training set was established

As there is no mention of a training set (as discussed in point 8), this question is not applicable. The device's "ground truth" for its development would be based on the established scientific principles of electrochemical measurement for ions.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name.

July 19, 2019

Nova Biomedical Corporation Cesidio Tempesta Regulatory Affairs Manager 200 Prospect St. Waltham, MA 02454

Re: K191365

Trade/Device Name: Stat Profile Prime ES Comp Plus Analyzer System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JJE Dated: May 20, 2019 Received: May 22, 2019

Dear Cesidio Tempesta:

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. 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 located 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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number K191365

Device Name

Stat Profile Prime ES Comp Plus Analyzer System

Indications for Use (Describe)

The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Sodium, and Chloride in heparinized venous whole blood, plasma and serum.

Sodium (Na)

Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium (K)

Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride (CI)

Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cvstic fibrosis and diabetic acidosis.

Type of Use (Select one or both, as applicable)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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 Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."

{3}------------------------------------------------

510(k) Summary K191365

510(K) Owner:	Nova Biomedical Corporation
Registration Number:	1219029
Address:	200 Prospect St.Waltham, MA 02454
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Cesidio Tempesta, Regulatory Affairs Manager
Date Prepared:	18 July, 2019

Proprietary Name: Stat Profile Prime ES Comp Plus Analyzer System

Common or Usual Name: Blood Gas/Electrolyte Analyzer

Classification Name: Multiple

Classification Names:	Reg. No.	Class	Product Code	Panel
Sodium Test System	862.1665	II	JGS
Potassium Test System	862.1600	II	CEM	Chemistry
Chloride Test System	862.1170	II	CGZ	(75)
Analyzer, chemistry (photometric, discrete), for clinical use	862.2160	I	JJE

Product Codes: JGS, CEM, CGZ

Predicate Devices:

K110648 - Nova Stat Profile pHOx Ultra Blood Gas Analyzer

Device Description:

The two options for the sensor card are:

. Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed ● analytes: pH, Hct, Na, K, CI, iCa, iMg

As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure sodium, potassium, and chloride.

{4}------------------------------------------------

Calibration standards are provided in sealed pouches within a callbrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.

The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.

Measured Parameters:

The Stat Profile Prime ES Comp Plus Analyzer measures Na+, K+, and Cl-.

Intended Use:

Indication for Use:

Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Summary of the Technological Characteristics:

The Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent to the previously cleared for market Nova Stat Profile pHOx Ultra Blood Gas Analyzer System in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the external controls and the calibration cartridge are the same for the tested parameters. The linearity standards and External Control solutions for use with the Stat Profile Prime ES Comp Plus Analyzer are substantially equivalent to those cleared for use with the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer System (K110648).

{5}------------------------------------------------

Table Error! No text of specified style in document.-1: Comparison of Predicate and Proposed devices

Characteristic	Predicate Stat Profile pHOx UltraBlood Gas Analyzer (K110648)	Proposed Stat Profile Prime ESComp Plus Analyzer
Indication For Use	The STP pHOx Ultra Analyzer withoutCO-Oximeter is intended for in vitrodiagnostic use by health careprofessionals and/or point-of-careusage in the quantitativedetermination of pH, PCO2, PO2,SO2%, Hematocrit (Hct), Hemoglobin(Hb) in heparinized whole blood; Na+,K+, Cl-, Ca++, Mg++, Glucose (Glu),Lactate (Lac), BUN (Urea), andCreatinine (Creat) in heparinizedwhole blood, serum, or plasma.	The Stat Profile Prime ES Comp PlusAnalyzer System is intended for invitro diagnostic use by health careprofessionals in clinical laboratorysettings for the quantitativedetermination of pH, Hematocrit,Sodium, Potassium, Chloride,Calcium and Magnesium inheparinized venous whole blood, andpH, Sodium, Potassium, Chloride,Calcium and Magnesium in plasmaand serum.
Acceptable Samples	Sodium or lithium heparinized wholeblood, serum, or plasma samplesfrom syringes, open tubes, smallcups, and capillary tubes can be usedon the STP pHOx Ultra Analyzer.	Lithium heparin whole blood, serumand plasma samples from syringes,open tubes, and small cups
Sample Volumes	60-210µL dependent on selected testpanel	100µL
Measurement Range
Na+	80 - 200 mmol/L	Same
K+	1.0 - 20.0 mmol/L	Same
Cl-	50 - 200 mmol/L	Same
Principles ofMeasurement
Na+	Sodium ion-selective glass sensor	Same
K+	Potassium ion-selective sensor	Same
Cl-	Chloride ion-selective sensor	Same
Touch Screen	12.1" LCD, 1024x768 pixel, ResistiveTouch	5.7" VGA full color display with LEDbacklight and integrated touch panel
Menu	Fully configurable test menu based onabove sensors	Same
Bar Code Scanner	External (optional) 1D	Internal Integrated 1D/2D
Printer	2" Roll, Thermal Transfer	Same
Pump	Peristaltic Pump w/ Pressure Plate,TPE Tubing (Pharmed BPT)	Same
Analog Board	Precision low level analog front endw/ amperometric and potentiometricamplifiers, air detector circuitry andtemperature control circuitry	Same

Summary of Performance Testing:

{6}------------------------------------------------

Performance testing was completed to demonstrate that the Stat Profile Prime ES Comp Plus Analyzer is substantially equivalent in performance, safety and efficacy to the predicate Nova Stat Profile pHOx Ultra Blood Gas Analyzer (K110648).

The performance testing included:

Method Comparison Studies .
Precision/Reproducibility Studies ●
. Run to Run Precision
Linearity Testing
Specificity / Interference Testing ●
Detection Limit
. Shelf Life Stability Testing

The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device).

Conclusion:

The results of software validation and performance verification testing confirmed that the Stat Profile Prime ES Comp Plus Analyzer is safe and effective for its intended purpose and that the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of K110648 - Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device).

Regulation Number and Section

§ 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.