(119 days)
Not Found
No
The document describes a standard critical care blood analyzer and explicitly states the scope of the 510(k) is limited to an operating system upgrade. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is for diagnostic purposes, providing quantitative measurements of various parameters in blood to aid in diagnosis, not to apply therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the parameters measured by the device "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance." It then lists various specific measurements and how they are "used in the diagnosis and treatment of" numerous medical conditions.
No
The device description explicitly states it is a "portable critical care system" and an "instrument" that provides quantitative measurements from blood samples, indicating it includes hardware for sample analysis. The performance studies also mention "Software Verification and Validation" in the context of an operating system upgrade, implying the software runs on a physical device.
Based on the provided text, the GEM Premier ChemSTAT is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly stated to be used for analyzing "lithium heparinized whole blood samples" to provide "quantitative measurements" of various parameters. These measurements are then used to "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance."
- Specific Diagnostic Applications: The "Intended Use / Indications for Use" section details how the measurements of each parameter are used in the "diagnosis and treatment" of various diseases and conditions (e.g., diagnosis and treatment of aldosteronism, monitoring electrolyte balance, diagnosis and treatment of renal diseases).
- Sample Type: The device analyzes "whole blood samples," which are biological specimens taken from the human body.
- Purpose: The purpose is to obtain information about a patient's health status through the analysis of these samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance.
Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. · Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
· pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Product codes (comma separated list FDA assigned to the subject device)
CGA, JGS, CEM, CGZ, JFP, CHL, KHP, GKF, JFY, CDQ, KHS
Device Description
The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.
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 to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
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)
All verification and validation activities were performed in accordance to established plans and protocols and Design Control procedures. Testing verified all acceptance criteria were met.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 27, 2023
Instrumentation Laboratory Co. Gabriella Erdosy Director of Regulatory Affairs 180 Hartwell Road Bedford, MA 01730
Re: K223090
Trade/Device Name: GEM Premier ChemSTAT Regulation Number: 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, JGS, CEM, CGZ, JFP, CHL, KHP, GKF, JFY, CDQ, KHS Dated: September 29, 2022 Received: September 30, 2022
Dear Gabriella Erdosy:
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/cfpmp/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 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 medical devices and radiation-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.
Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2023.01.27
18:12:23 -05'00'
Paula V. Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223090
Device Name
GEM Premier ChemSTAT
Indications for Use (Describe)
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium (Na+), Potassium (K+), Ionized Calcium (Ca++), Chloride (Cl-), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance.
Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. · Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
· Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
· Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
· Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
· Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
· pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
3
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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4
Image /page/4/Picture/0 description: The image contains the logo for Instrumentation Laboratory, a Werfen Company. The logo features a stylized graphic of three overlapping shapes in green and blue. The text "Instrumentation Laboratory" is written in a sans-serif font to the right of the graphic. Below the company name, the text "A Werfen Company" is written in a smaller font.
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co.
180 Hartwell Road
Bedford, MA 01730, USA |
| ------------------------- | ------------------------------------------------------------------------------------ |
|---|
| Contact Person | Gabriella Erdosy
Director of Regulatory Affairs
Phone: 781-861-4571
Fax: 781-861-4207
Email: gerdosy@werfen.com |
| ---------------- | ----------------------------------------------------------------------------------------------------------------------------- |
|---|
| Preparation Date | September 29, 2022 |
|---|---|
| ------------------ | -------------------- |
| 510(k) Number | K223090 |
|---|---|
| --------------- | --------- |
| Device Trade Name | GEM Premier ChemSTAT |
|---|---|
| ------------------- | ---------------------- |
| Predicate Device | GEM Premier ChemSTAT | K183549, K183546, K183555 |
|---|---|---|
| ------------------ | ---------------------- | --------------------------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier ChemSTAT | |||||
| Analyte | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | Panel | ||||
| pH, pCO2 | 862.1120 | Blood Gases (pCO2, pO2) and Blood | |||
| pH system | II | CHL | |||
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | |
| Chloride | 862.1170 | Chloride test system | II | CGZ | 75 |
5
| Ionized
| Calcium | 862.1145 | Calcium test system | II | JFP | |
|---|---|---|---|---|---|
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I | KHP | |
| Regulatory Information | |||||
| GEM Premier ChemSTAT | |||||
| Regulation | |||||
| Analyte | Section | Regulatory Description | Class | Product | |
| Code | Panel | ||||
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | 81 |
| Creatinine | 862.1225 | Creatinine Test System | II | JFY | |
| Blood Urea | |||||
| Nitrogen | |||||
| (BUN) | 862.1770 | Urea Nitrogen Test System | II | CDQ | 75 |
Device Description
The GEM Premier ChemSTAT system provides fast, accurate, quantitative measurements of Sodium (Na"), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl·), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous lithium heparinized whole blood.
Risk Management
The Risk Management was performed in compliance with ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices. A series of risk assessments were performed in order to identify and mitigate any potential risks associated to the design changes for the modified device.
Verification and Validation Summary
All verification and validation activities were performed in accordance to established plans and protocols and Design Control procedures. Testing verified all acceptance criteria were met.
Cybersecurity Information
Cybersecurity assessments for the GEM Premier ChemSTAT were performed as part of the Quality Management procedures for software validation and risk analysis activities. Vulnerabilities were identified, assessed and compensating controls were implemented within the software/system, to mitigate potential security threats, system vulnerabilities, viral attacks and safeguard against unauthorized access to patient data.
6
Reason for Submission
This Special 510(k) is being submitted to upgrade the operating system from Fedora 17 Linux to WindRiver LTS 18 Linux for the GEM Premier ChemSTAT Instrument. The operating system is being upgraded to accommodate long-term support of resolutions for common vulnerability exposures. The software changes are limited to those required as part of Linux Wind River LTS 18 operating system (OS) and associated changes for the GEM Premier ChemSTAT application software to support the OS change, strengthen cybersecurity, and overall system improvements and reliability.
The submission meets the criteria for a Special 510(k) based on the following:
- The proposed change is submitted by the manufacturer legally authorized to market the existing device. .
- Performance data is limited to Software Verification and Validation as the scope of this Special 510(k) is . specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux.
- There is a well-established method to evaluate the change: ●
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January O 11,2002
- Guidance for the Content of Premarket Submissions for Software Contained in Medical O Devices, May 11, 2005
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices O Guidance for Industry and Food and Drug Administration Staff, October 2, 2014
- Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug o Administration Staff, September 2019
- The data can be reviewed in a summary or risk analysis format.
In addition, the changes in this submission do not introduce:
- Changes to indications for use or intended use .
- Changes to the fundamental scientific technology .
- Changes to operating principle ●
- Changes to labeled performance claims ●
7
Indications for Use / Intended Use
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na ), Potassium (K*), Ionized Calcium (Ca*), Chloride (Cl*), Glucose (Glu), Lactate (Lac), Hematocrit (Hct), Creatinine (Crea), Blood Urea Nitrogen (BUN), Total Carbon Dioxide (tCO2), pH, and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance. Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary
- with electrolytes:
- . Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
- Potassium (K) measurements are used to monitor electrolyte balance in the diagnosis and ● treatment of disease conditions characterized by low or high blood potassium levels.
- . Ionized calcium (Ca") measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
- . Chloride (Cl') measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.
- . Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- . Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
- Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- . Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
- Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
- Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3 ) is used in the diagnosis, ●
monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
- pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening . acid-base disturbances.
8
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate | |
| (K183549, K183546 and K183555) | Updated Device | |
| Subject of this | ||
| Submission | ||
| Similarities | ||
| Trade Name | GEM Premier ChemSTAT | Same |
| Indications for Use | See above | Same |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2 | Same |
| Electrolyte Measurement | Potentiometry: Na+, K+, Cl-, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | |
| Potentiometry: tCO2 | Same | |
| Hematocrit Measurement | Conductivity | Same |
| BUN | Enzymatic Potentiometry | Same |
| Creatinine | Enzymatic Amperometry | Same |
| Sample Introduction | Aspiration | Same |
| Sampling Modes | ||
| And Sample Volumes | • Normal Mode | |
| 150 μL | Same | |
| Test Principle | • Potentiometry: pH, pCO2, tCO2, Na+, K+, Cl-, Ca++ | |
| • Amperometry: Glucose and Lactate | ||
| • Conductivity: Hematocrit | ||
| • Enzymatic Potentiometry : BUN | ||
| • Enzymatic Amperometry: Creatinine | Same | |
| Sample Type | Lithium Heparinized whole blood (arterial and | |
| venous) | Same | |
| Dimensions | • Height: 18.5 inches | |
| • Width: 13.1 inches | ||
| • Depth: 16.3 inches | Same | |
| Weight | • 42.1 pounds | Same |
| System Operating Temperature | • 12-32°C (53.6°F to 89.6°F) | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Sample Introduction | Aspiration | Same |
| Differences | ||
| Operating System Software | Fedora 17 Linux | Wind River LTS 18 Linux |
9
| Conclusion | The GEM Premier ChemSTAT, with the change in its operating system from
Fedora 17 Linux to WindRiver LTS 18 Linux is substantially equivalent to the
legally marketed predicate device last FDA cleared under K183549, K183546
and K183555. |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|