(75 days)
Not Found
No
The document describes a blood gas analyzer and its software verification and validation, but there is no mention of AI or ML technologies.
No
The device is described as an analytical instrument that provides quantitative measurements and aids in diagnosis; it does not directly treat or alleviate a disease, injury, or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the parameters obtained from the device "aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a "portable system" and an "instrument" that analyzes "whole blood samples," indicating it includes hardware components for sample analysis and portability. While software verification and validation are mentioned, this is standard for medical devices with software components and does not imply it is software-only.
Yes, the GEM Premier 3000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "rapidly analyze whole blood samples" and provides "quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct." These are all analyses performed in vitro (outside the body) on biological specimens (whole blood).
- Purpose: The results from these analyses "aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device description reinforces that it analyzes "whole blood samples" and provides "measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate."
The information provided clearly indicates that the GEM Premier 3000 is designed and intended for the in vitro examination of human specimens for diagnostic purposes, which is the core definition of an IVD.
N/A
Intended Use / Indications for Use
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CHL, JGS, CEM, JFP, KHP, GKF
Device Description
The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.
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, central laboratory or point-of-care clinical 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)
Software verification and validation was performed according as defined in the GEM Premier 3000 V6.3.0 Project Software Verification Plan (Document No. L0024004020, See Section 32) and in accordance with the Software Design Verification Procedure. Software Validation was performed as defined in the GEM 3X00 Software Design and Development Plan for SBC Project (Document No. L0024003937, See Section 30). Testing verified that the SW V6.3.0 change meets requirements and that no new hazards have been introduced. This is documented in the GEM Premier 3000 V6.3.0 Software Verification report (Document No. L0024004116, See Section 33), and the GEM Premier 3000 V6.3.0 Software Validation Assessment (Document No. L0024005866, See Section 35).
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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INSTRUMENTATION LABORATORY CO. NIKITA MALLADI REGULATORY AFFAIRS SPECIALIST II 180 HARTWELL ROAD BEDFORD MA 01730
September 14, 2016
Re: K161818 Trade/Device Name: GEM Premier 3000 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, CHL, JGS, CEM, JFP, KHP, KFG Dated: August 12, 2016 Received: August 15, 2016
Dear Nikita Malladi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161818
Device Name GEM Premier 3000
Indications for Use (Describe)
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
| 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 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
Image /page/3/Picture/0 description: The image shows the logo for Instrumentation Laboratory. The logo consists of a green and blue graphic to the left of the company name. Below the company name is the text "A Werfen Company".
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 | Nikita Malladi
Regulatory Affairs Specialist II
Phone: 781-674-3245
Fax: 781-861-4207
Email: nmalladi@ilww.com |
| ---------------- | ---------------------------------------------------------------------------------------------------------------------------- |
|---|
| Preparation Date | September 12, 2016 |
|---|---|
| ------------------ | -------------------- |
| Device Trade Names | GEM Premier 3000 |
|---|---|
| -------------------- | ------------------ |
| Predicate Device | GEM Premier 3000 | K052121 |
|---|---|---|
| ------------------ | ------------------ | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | Panel | ||||
| pH, pCO2, pO2 | 862.1120 | Blood Gases (pCO2, pO2) and Blood pH system | II | CHL | 75 |
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | |
| 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 | |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | 81 |
4
Device Description
The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.
Indications for Use / Intended Use
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na , K , Ca *, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Reason for Submission
This Special 510(k) is being submitted to update the operating system from Linux Fedora Core 7 to Linux Fedora Core 21 for GEM Premier 3000 Instruments. The operating system is being updated to accommodate a change in the single-board computer due to obsolescence.
The submission meets the criteria for a Special 510(k) based on the following:
- No change in indications for use or intended use
- No change in operating principle
- No change to labeled performance claims
- No change to data reduction software
- No change to fluidic design
- No change to GEM cartridges or CVP material
5
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate (K052121) | Updated Device Subject of this Submission |
| Similarities | ||
| Trade Names | GEM Premier 3000 | Same |
| Indications for Use | See above | Same |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2 | |
| Amperometry: pO2 | Same | |
| Electrolyte Measurement | Potentiometry: Na+, K+, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Hematocrit Measurement | Conductivity | Same |
| Sample Introduction | Aspiration | Same |
| Test Principle | Potentiometry: pH, pCO2, Na+, K+, Ca++ Amperometry: pO2, Glu, Lac Conductivity: Hematocrit | Same |
| Sample Type | Whole blood for all analytes | Same |
| Dimensions | GEM3000 - 17 (H) x 12 (W) x 12 (D)" | Same |
| Weight | GEM3000 – 29.5 pounds | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Sample Introduction | Aspiration | Same |
| Controls | In conjunction with iQM: | |
| GEM CVP 1, GEM CVP 2, | ||
| GEM CVP 3 and GEM CVP 4 | Same | |
| Differences | ||
| Software | GEM Premier 3000 V6.2.5 | GEM Premier 3000 V6.3.0 |
| Operating System Software | Linux Fedora Core 7 | Linux Fedora Core 21 |
| Single Board Computer | Win Enterprises 90140 Intel Pentium® M® / Celeron® M processor, 400MHz - ETX Module | Seco Q7-BT Rel. 2.0 Module with the Intel® Atom™ E3800 |
6
| Declaration of Conformance to
Design Controls | As required by the risk analysis, all verification and validation activities were
performed and the results demonstrated that the predetermined
acceptance criteria were met. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Verification and Validation
Summary | Software verification and validation was performed according as defined in
the GEM Premier 3000 V6.3.0 Project Software Verification Plan (Document
No. L0024004020, See Section 32) and in accordance with the Software
Design Verification Procedure. Software Validation was performed as
defined in the GEM 3X00 Software Design and Development Plan for SBC
Project (Document No. L0024003937, See Section 30).
Testing verified that the SW V6.3.0 change meets requirements and that no
new hazards have been introduced. This is documented in the GEM
Premier 3000 V6.3.0 Software Verification report (Document No.
L0024004116, See Section 33), and the GEM Premier 3000 V6.3.0 Software
Validation Assessment (Document No. L0024005866, See Section 35). |
| Conclusion | Based on the shared indications for use, operating principle and
performance claims, the GEM Premier 3000 with software V6.3.0 running
on the Linux Fedora Core 21 operating system can be concluded to be
substantially equivalent to the cleared and currently marketed predicate
device, GEM Premier 3000. |