(77 days)
No
The summary does not mention AI, ML, or related terms, and the performance studies focus on linearity and detection limits of standard analytical measurements.
No.
The device is a diagnostic tool that analyzes blood samples to aid in diagnosis, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the measured parameters "aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance."
No
The device description explicitly states it is a "portable system" that "rapidly analyze whole blood samples," indicating it includes hardware components for sample analysis. The software update mentioned is for extending reportable ranges, not the sole function of the device.
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 samples.
- Purpose: The results of 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 description confirms it analyzes "whole blood samples."
Therefore, based on the provided information, the GEM Premier 3000 clearly fits the definition of an In Vitro Diagnostic device.
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, KPH
Device Description
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.
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 whole blood samples at the point of health care delivery in a clinical setting.
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)
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.
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.
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.
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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.
1
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
3
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