(58 days)
Not Found
No
The document describes a standard electrolyte analyzer using ion selective electrode technology and a microprocessor. There is no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) device used to measure quantitative levels of certain analytes in blood, plasma, and serum, which aids in the diagnosis and monitoring of various conditions. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use..." and describes its use for the quantitative determination of various substances for the diagnosis and treatment of diseases.
No
The device description clearly outlines hardware components such as the analyzer, sensor cartridges, thermal paper, and an optional sample tray. It also describes the use of ion selective electrode technology, which is a hardware-based measurement method.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the 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."
- Purpose: The measurements are used in the "diagnosis and treatment of disease conditions" involving electrolyte imbalances, aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, cystic fibrosis, and diabetic acidosis. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Sample Type: The device analyzes "heparinized venous whole blood, plasma and serum," which are specimens derived from the human body.
- Setting and User: It is intended for use by "health care professionals in clinical laboratory settings," a typical environment for IVD use.
N/A
Intended Use / Indications for Use
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 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 cvstic fibrosis and diabetic acidosis.
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.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, JJE
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.
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
health care professionals in clinical laboratory settings
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)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1665 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.
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 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.
4
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.
Measured Parameters:
The Stat Profile Prime ES Comp Plus Analyzer measures Na+, K+, and Cl-.
Intended Use:
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.
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 Ultra
Blood Gas Analyzer (K110648) | Proposed Stat Profile Prime ES
Comp Plus Analyzer |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The STP pHOx Ultra Analyzer without
CO-Oximeter is intended for in vitro
diagnostic use by health care
professionals and/or point-of-care
usage in the quantitative
determination of pH, PCO2, PO2,
SO2%, Hematocrit (Hct), Hemoglobin
(Hb) in heparinized whole blood; Na+,
K+, Cl-, Ca++, Mg++, Glucose (Glu),
Lactate (Lac), BUN (Urea), and
Creatinine (Creat) in heparinized
whole blood, serum, or plasma. | 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 pH, Hematocrit,
Sodium, Potassium, Chloride,
Calcium and Magnesium in
heparinized venous whole blood, and
pH, Sodium, Potassium, Chloride,
Calcium and Magnesium in plasma
and serum. |
| Acceptable Samples | Sodium or lithium heparinized whole
blood, serum, or plasma samples
from syringes, open tubes, small
cups, and capillary tubes can be used
on the STP pHOx Ultra Analyzer. | Lithium heparin whole blood, serum
and plasma samples from syringes,
open tubes, and small cups |
| Sample Volumes | 60-210µL dependent on selected test
panel | 100µL |
| Measurement Range | | |
| Na+ | 80 - 200 mmol/L | Same |
| K+ | 1.0 - 20.0 mmol/L | Same |
| Cl- | 50 - 200 mmol/L | Same |
| Principles of
Measurement | | |
| 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, Resistive
Touch | 5.7" VGA full color display with LED
backlight and integrated touch panel |
| Menu | Fully configurable test menu based on
above 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 end
w/ amperometric and potentiometric
amplifiers, air detector circuitry and
temperature 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).