(77 days)
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.
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 that was originally cleared for the U.S. market under K992834, with glucose and lactate parameters added under K010520 and Intelligent Quality Management (iQM) introduced under K022158. The reportable ranges for the Glucose and Lactate parameters are being extended through additional performance testing with the release of a new software version.
The provided text describes an extension of the reportable ranges for Glucose and Lactate parameters on the GEM Premier 3000 device. The study to prove this involved linearity data and detection limit testing.
Here's the information extracted and organized:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for extending the reportable ranges were based on achieving satisfactory linearity as demonstrated by the slope, intercept, and R-squared values from linearity testing. Specific numerical acceptance criteria for these metrics are not explicitly stated as target values, but the reported values indicate the device meets the linearity and detection limit requirements for the extended ranges.
| Parameter | Acceptance Criteria (Implied by study results for extension) | Reported Device Performance (Linearity Data) |
|---|---|---|
| Glucose (mg/dL) | Linear response across the extended range (5 to 500 mg/dL) | Slope: 1.012, Intercept: -1.369, R2: 0.997 |
| Lactate (mmol/L) | Linear response across the extended range (0.2 to 15 mmol/L) | Slope: 1.031, Intercept: -0.028, R2: 0.999 |
Note: The "Acceptance Criteria" column is inferred from the statement that the reportable ranges were extended based on the provided data, implying these performance metrics met the necessary thresholds.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Glucose: 30-32 samples per level
- Lactate: 32-33 samples per level
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be an internal performance evaluation for regulatory submission, likely conducted in a controlled lab setting, which could be considered prospective in nature for new range validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is a performance validation for an in vitro diagnostic device, specifically focusing on linearity and detection limits. Ground truth is established by the known concentrations of calibrators or reference materials used for the linearity testing, not by expert interpretation.
4. Adjudication method for the test set
Not applicable. This type of study does not involve adjudication as it's a technical performance validation against quantitative standards, not qualitative assessments requiring expert consensus.
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
Not applicable. This is a 510(k) summary for an in vitro diagnostic device measuring blood analytes, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The reported "Performance Data Summary" outlines the linearity of the device's measurements for Glucose and Lactate, which directly reflects the algorithm's (or device's) ability to accurately quantify these parameters across the extended ranges. The study focuses on the device's inherent measurement capabilities.
7. The type of ground truth used
The ground truth for the linearity testing would be the known concentrations of reference materials or calibrators spanning the reportable range. These are precisely prepared solutions with verified analyte concentrations. For Lactate, it's mentioned that samples were "stabilized through repeated washing and icing in vitro for testing," indicating controlled preparation to achieve specific concentrations.
8. The sample size for the training set
Not applicable. This device is not described as utilizing a machine learning algorithm that requires a separate training set. The performance validation is based on direct measurement principles.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
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Section 3
K 05212/
GEM Premier 3000: Extension of Glucose and Lactate Reportable Ranges 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
August 4, 2005
Name of the Device:
GEM Premier 3000
Classification Name:
| CGA | Glucose Oxidase, Glucose | |
|---|---|---|
| 862.1345 | Glucose Test System | Class II |
| KHP | Lactic Acid, Lactate | |
| 862.1450 | Lactic Acid Test System | Class I |
Identification of predicate device:
K022158 GEM Premier 3000
Description of the modified device:
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 that was originally cleared for the U.S. market under K992834, with glucose and lactate parameters added under K010520 and Intelligent Quality Management (iQM) introduced under K022158.
The reportable ranges for the Glucose and Lactate parameters are being extended through additional performance testing with the release of a new software version.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The GEM Premier 3000 with extended reportable ranges for Glucose and Lactate is substantially equivalent in performance, intended use, safety and effectiveness to the currently marketed GEM Premier 3000.
Performance Data Summary:
Based on detection limit testing and the linearity data presented below, the claimed reportable ranges in the Operator's Manual were extended for glucose from "20 to 500 mg/dL" to "5 to 500 mg/dL" and lactate from "0.3 to 15 mmol/l" to "0.2* to 15 mmol/l":
| Parameter | N per Level | Slope | Intercept | R2 |
|---|---|---|---|---|
| Glucose (mg/dL) | 30-32 | 1.012 | -1.369 | 0.997 |
| Lactate (mmol/L) | 32-33 | 1.031 | -0.028 | 0.999 |
*NOTE: Due to the instability of Lactate in whole blood, samples used to establish the 0.2 mmol/L concentration were stabilized through repeated washing and icing in vitro for testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is facing left and is composed of three thick, curved lines. The text is in all caps and is arranged in a circular fashion around the eagle.
OCT 2 1 2005
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
Re: K052121 Trade/Device Name: GEM Premier 3000
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, KPH Dated: October 11, 2005 Received: October 12, 2005
Dear Ms. Marble:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: GEM Premier 3000
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Lacy Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052121
§ 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.