(209 days)
No
The document describes a critical care system with an "Intelligent Quality Management (iQM)" system for quality control. While the term "Intelligent" is used, the description of iQM focuses on "continuous monitoring," "real-time, automatic error detection," "automatic correction," and "automatic documentation." These functions are typically achieved through rule-based programming and automation, not necessarily AI/ML. There is no mention of learning, training data, or algorithms characteristic of AI/ML. The focus of the submission is on a modification to the potassium sensor and its performance studies, which are standard for medical devices and do not indicate AI/ML use.
No.
The device is used for analyzing blood samples to aid in diagnosis, not for treating any conditions.
Yes
The device analyzes whole blood samples and quantifies various parameters (e.g., pH, pCO2, sodium, glucose) that "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity." It also explicitly states that "Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin," and in neonates, "the level of total bilirubin is used to aid in assessing the risk of kernicterus."
No
The device is described as a "portable critical care system" that analyzes whole blood samples using various sensors (pH, pCO2, pO2, etc.). While it includes software components like iQM, the core function relies on physical hardware for sample analysis. The modification described is to a "potassium (K+) sensor membrane," which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
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 pH, pCO2 pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry... These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity." This clearly indicates that the device is used to examine specimens derived from the human body (whole blood and plasma) to provide information for the purpose of diagnosis.
- Specimen Type: The device analyzes "whole blood samples" and "heparinized plasma samples," which are human specimens.
- Purpose: The measurements provided by the device "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity" and "Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin." This directly aligns with the definition of an IVD, which is used to provide information for diagnostic purposes.
- Setting: The device is used "at the point of health care delivery in a clinical setting and in a central laboratory," which are typical settings for IVD use.
The description of the device, the performance studies conducted (precision, linearity, interference, method comparison, field site testing), and the comparison to predicate and reference devices further support its classification as an IVD. These are all standard elements of regulatory submissions for IVD devices.
N/A
Intended Use / Indications for Use
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, pCO2 pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKF, GHS, GKR, GLY, CIG, MQM, JJY, GLK
Device Description
The potassium (K+) sensor membrane on the GEM Premier 4000 is being modified to lower the valinomycin concentration, along with a proportional decrease in the amount of counterion.
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
neonates
Intended User / Care Setting
health care professionals, 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)
- Precision: A precision study was conducted to evaluate the performance of the GEM Premier 4000 with the modified K+ sensor using whole blood. Each whole blood sample level was assayed twice per day in eight replicates for five days on two GEM Premier 4000 analyzers using the three sample modes: syringe, full capillary and micro capillary. All K+ results for whole blood precision were within specification.
- Linearity: A linearity study was performed to evaluate the performance of the GEM Premier 4000 with the modified K+ sensor. Whole blood samples were manipulated through spiking and diluting to 7 different K+ concentrations spanning the claimed reportable range of 0.2 to 19 mmol/L. Flame atomic emission photometry (flame photometry), the preferred method to standardize direct ionselective electrode analyzers for determination of K+, acted as the reference method in testing. Each concentration was tested in duplicate on the reference Flame Photometer and in triplicate on 3 different GEM Premier 4000 analyzers using the 3 sample modes: syringe, full capillary and micro capillary. The linearity results support the current claimed reportable range of 0.2 to 19.0 mmol/L for the modified K+ sensor on the GEM Premier 4000, using all sampling modes (syringe, full capillary and micro capillary).
- Interferences: Interference testing was performed on a list of substances using the GEM Premier 4000 with the modified K+ sensor. Only citrate at concentrations at >= 7.3 mmol/L showed a clinically significant interference effect on the modified K+ sensor.
- Method Comparison: An internal method comparison study was performed to compare the GEM Premier 4000 with the modified K+ sensor vs. GEM Premier 3000. All three sample modes were tested, with N=220 for each mode. The K+ performance on the GEM Premier 4000 with the modified K+ sensor is comparable to the GEM Premier 3000 for all sample modes.
- Field Site Testing: External field testing was performed to compare the GEM Premier 3000/3500 vs. GEM Premier 4000 with the modified K+ sensor in the clinical setting. All three sample modes were tested at three field sites. Sample sizes were N=454 for Syringe, N=304 for Full Capillary, and N=304 for Micro Capillary. The K+ performance on the GEM Premier 4000 with the modified K+ sensor is comparable to the GEM Premier 3000/3500 for all sample modes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: %CV and SD for K+ mean.
Linearity: R^2 values
Method Comparison & Field Site Testing: Slope, Intercept, R2.
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
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logos for Werfen Group and Instrumentation Laboratory. The Werfen Group logo is a globe-like image with horizontal lines and the text "Werfen Group" below it. The Instrumentation Laboratory logo is a geometric shape resembling a cube with the text "Instrumentation Laboratory" to the right of it.
MAY - 3 2012
510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. .
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 180 Hartwell Road |
| Bedford, MA 01730 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| E-mail: | cmarble@ilww.com |
| Preparation Date: | April 25, 2012 |
Proprietary Name:
GEM® Premier 4000 with iQM® (Intelligent Quality Management) GEM® CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM® CVP 3 and 4 (Calibration Valuation Product) Hematocrit GEM® CVP 5 (Calibration Valuation Product) tBili
Regulatory Information:
- GEM Premier 4000 with iQM (Intelligent Quality Management) .
| Description | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Blood gases and blood pH | 862.1120 | Class II | CHL |
| Sodium test system | 862.1665 | Class II | JGS |
| Potassium test system | 862.1600 | Class II | CEM |
| Calcium test system | 862.1145 | Class II | JFP |
| Chloride test system | 862.1170 | Class II | CGZ |
| Glucose test system | 862.1345 | Class II | CGA |
| Lactic acid test system | 862.1450 | Class I | KHP |
| Automated hematocrit instrument | 864.5600 | Class II | GKF |
| Carboxyhemoglobin assay | 864.7425 | Class II | GHS |
| Automated hemoglobin system | 864.5620 | Class II | GKR |
| Whole blood hemoglobin assays | 864.7500 | Class II | GLY |
| Bilirubin (Total or Direct) | |||
| Test System | 862.1110 | Class II | CIG |
| (Total and Unbound) in the | |||
| Neonate Test System | 862.1113 | Class I, | |
| Reserved | MQM |
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Regulatory Information (Cont.):
- GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox .
- GEM CVP 5 (Calibration Valuation Product) tBili .
| Description | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Quality Control Material | 862.1660 | Class I | JJY |
GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit
| Description | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Hematocrit Control | 864.8625 | Class II | GLK |
Predicate Device:
GEM Premier 4000 with iOM
Original K061974; Update K093623
Description of Device Modification:
The potassium (K+) sensor membrane on the GEM Premier 4000 is being modified to lower the valinomycin concentration, along with a proportional decrease in the amount of counterion. This modification is being made to bring the K+ performance on the GEM Premier 4000 back to the original labeled claims as cleared under K061974 (no change to K+ claims under K093623).
- There are no changes to the following with this submission: .
- No expansion or change in indications for use /intended use .
- . No change to performance claims, except to introduce sodium citrate as an interferent
- No change to software ●
- No change to instrument or cartridge hardware beyond the K+ sensor modifications .
- No change to the fluidic design ●
- · No change to sensor fundamental technology, including for the K+ sensor
- No change to cartridge bag solutions or other measuring sensors ●
- No change to labeling of the cartridge ●
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Indications for Use (No Change from K093623):
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, pCO2 pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Comparison to Predicate Device:
Following are the similarities and differences between the current and modified K+ sensor membrane on the GEM Premier 4000:
- Similarities: .
- Same Indications for Use / Intended use .
- Same Test Environment .
- Same Operating Principle (Potentiometric Measurement) ●
- Same Membrane Geometry .
- Same Membrane Components .
- Same Performance Characteristics, except to introduce sodium citrate as an interferent .
- Differences limited to membrane formulation: .
- Lowered valinomvcin concentration .
- Proportional decrease in the amount of counterion .
Standards Referenced (if applicable):
- CLSI EP5-A2, Evaluation of Precision Performance of Clinical Chemistry Devices ●
- CLSI EP6-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A . Statistical Approach
- CLSI EP7-A2, Interference Testing in Clinical Chemistry ●
- CLSI EP9-A2. Method Comparison and Bias Estimation Using Patient samples ●
- CLSI EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation ●
- CLSI EP-25-A. Evaluation of Stability of In Vitro Diagnostic Reagents .
- CLSI C29-A2, Standardization of Sodium and Potassium Ion Selective Electrode Systems to ● the Flame Photometric Reference Method
3
Performance Characteristics Summary:
A series of studies were conducted that evaluated the performance of the GEM Premier 4000 system with the modified K+ sensor, including:
- Precision .
- . Linearity
- Interferences .
- Method Comparison ●
- Field Site Testing ●
Whole Blood Precision
A precision study was conducted to evaluate the performance of the GEM Premier 4000 with the modified K+ sensor using whole blood. Each whole blood sample level was assayed twice per day in eight replicates for five days on two GEM Premier 4000 analyzers using the three sample modes: syringe, full capillary and micro capillary.
The results are presented in Tables 1-3 below.
| Table 1: Whole Blood Precision Summary - Syringe Mode | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------- |
| Level | K+ Mean
(mmol/L) | N | Within Run
SD | Within Run
%CV | Total
Imprecision
SD | Total
Imprecision
%CV |
|---------|---------------------|-----|------------------|-------------------|----------------------------|-----------------------------|
| Level 1 | 2.90 | 160 | 0.04 | 1.51% | 0.04 | 1.51% |
| Level 2 | 3.88 | 160 | 0.05 | 1.32% | 0.05 | 1.32% |
| Level 3 | 7.41 | 160 | 0.06 | 0.86% | 0.06 | 0.86% |
| Level | K+ Mean
(mmol/L) | N | Within Run
SD | Within Run
%CV | Total
Imprecision
SD | Total
Imprecision
%CV |
|---------|---------------------|-----|------------------|-------------------|----------------------------|-----------------------------|
| Level 1 | 3.06 | 160 | 0.11 | 3.55% | 0.11 | 3.55% |
| Level 2 | 4.06 | 160 | 0.11 | 2.71% | 0.11 | 2.71% |
| Level 3 | 7.44 | 160 | 0.12 | 1.58% | 0.16 | 2.16% |
| Table 3: Whole Blood Precision Summary - Micro Capillary Mode | ||
|---|---|---|
| -- | -- | --------------------------------------------------------------- |
| Level | K+ Mean
(mmol/L) | N | Within Run
SD | Within Run
%CV | Total
Imprecision
SD | Total
Imprecision
%CV |
|---------|---------------------|------|------------------|-------------------|----------------------------|-----------------------------|
| Level 1 | 3.34 | 160 | 0.11 | 3.31% | 0.11 | 3.31% |
| Level 2 | 4.25 | 158* | 0.11 | 2.66% | 0.11 | 2.66% |
| Level 3 | 7.83 | 160 | 0.10 | 1.27% | 0.10 | 1.27% |
· One sample duplicate pair was discarded due to a pre-analytical issue.
Conclusion: All K+ results for whole blood precision were within specification.
4
Performance Characteristics Summarv (Cont.):
Linearity
A linearity study was performed to evaluate the performance of the GEM Premier 4000 with the modified K+ sensor. Whole blood samples were manipulated through spiking and diluting to 7 different K+ concentrations spanning the claimed reportable range of 0.2 to 19 mmol/L. Flame atomic emission photometry (flame photometry), the preferred method to standardize direct ionselective electrode analyzers for determination of K+, acted as the reference method in testing. Each concentration was tested in duplicate on the reference Flame Photometer and in triplicate on 3 different GEM Premier 4000 analyzers using the 3 sample modes: syringe, full capillary and micro capillary.
Graphs of the observed values (for each of the three GEM Premier 4000 instruments) versus the expected values (flame photometry) are provided below for the three sample modes: syringe (Figure 1), full capillary (Figure 2) and micro capillary (Figure 3). .
Image /page/4/Figure/4 description: This image is a graph titled "GEM Premier 4000 K+ Linearity Syringe Mode (3 GEM 4000 Instruments)". The graph plots "K+ from GEM 4000, mmol/L" on the y-axis and "K+ Target by Flame Photometry, mmol/L" on the x-axis. There are three trendlines plotted on the graph, with equations y = 1.0144x - 0.0612 (R^2 = 0.9999), y = 1.0085x - 0.0038 (R^2 = 0.9999), and y = 1.0438x - 0.165 (R^2 = 1).
Figure 1: GEM Premier 4000 in Syringe Mode (3 Instruments)
5
Image /page/5/Figure/0 description: The image is a graph titled "GEM Premier 4000 K+ Linearity Capillary Mode (3 GEM 4000 Instruments)". The x-axis is labeled "K+ Target by Flame Photometry, mmol/L" and ranges from 0.0 to 30.0. The y-axis is labeled "K+ from GEM 4000, mmol/L" and ranges from 0.0 to 30.0. There are three trendlines plotted on the graph, with equations and R^2 values displayed: y=1.0115x + 0.0251, R^2 = 0.9997; y = 1.0302x - 0.1058, R^2 = 0.9998; y = 1.0324x - 0.0435, R^2 = 0.9996.
GEM Premier 4000 in Micro Capillary Mode (3 Instruments) Figure 3:
Image /page/5/Figure/2 description: The image is a graph titled "GEM Premier 4000 K+ Linearity Micro Capillary Mode (3 GEM 4000 Instruments)". The graph shows the relationship between K+ from GEM 4000, mmol/L and K+ Target by Flame Photometry, mmol/L. There are three trendlines on the graph, with equations y = 1.068x - 0.136, y = 1.0791x - 0.2189, and y = 1.1017x - 0.2881, and R^2 values of 0.9999, 0.9998, and 0.9994 respectively.
Conclusion: The linearity results support the current claimed reportable range of 0.2 to 19.0 mmol/L for the modified K+ sensor on the GEM Premier 4000, using all sampling modes (syringe, full capillary and micro capillary).
6
Interferences
Interference testing was performed on the substances listed below using the GEM Premier 4000 with the modified K+ sensor. These substances represent endogenous substances found among common abnormalities (e.g., lipemia), common prescription and over-the-counter drugs, sample additives such as anticoagulants and preservatives, abnormal biochemical metabolites, and medications often prescribed for critically ill patients.
- Conclusion: Only citrate at concentrations at ≥ 7.3 mmol/L showed a clinically significant interference effect on the modified K+ sensor. Based on the results, the following limitation is being added to the labeling: "Blood collection tubes containing sodium citrate as an additive will produce a clinically significant change in potassium and should be avoided."
Method Comparison
An internal method comparison study was performed to compare the GEM Premier 4000 with the modified K+ sensor vs. GEM Premier 3000. All three sample modes were tested.
The summary results for each sample mode are presented in Table 5 below.
| r
| 0 | able | |||
|---|---|---|---|---|
| œ |
| | N | Range of Samples | Slope
(95% CI) | Intercept
(95% CI) | R2 |
|-----------------|-----|--------------------|---------------------------|---------------------------|-------|
| Syringe | 220 | 0.2 to 20.1 mmol/L | 0.978
(0.972 to 0.984) | 0.143
(0.112 to 0.174) | 0.998 |
| Full Capillary | 220 | 0.2 to 19.5 mmol/L | 0.980
(0.973 to 0.987) | 0.169
(0.135 to 0.204) | 0.997 |
| Micro Capillary | 220 | 0.2 to 20.6 mmol/L | 0.987
(0.980 to 0.995) | 0.276
(0.236 to 0.317) | 0.997 |
Conclusion: The above results support that across the reportable range, the K+ performance on the GEM Premier 4000 with the modified K+ sensor is comparable to the GEM Premier 3000 for all sample modes (syringe, full capillary and micro capillary).
Field Site Testing
External field testing was performed to compare the GEM Premier 3000/3500 vs. GEM Premier 4000 with the modified K+ sensor in the clinical setting. All three sample modes were tested at three field sites.
The pooled summary results for each sample mode are presented in Table 6 below.
7
Table 6:
| | N | Range of Samples | Slope
(95% CI) | Intercept
(95% CI) | R2 |
|-----------------|-----|-------------------|---------------------------|------------------------------|-------|
| Syringe | 454 | 2.0 to 7.5 mmol/L | 1.050
(1.040 to 1.061) | -0.106
(-0.147 to -0.064) | 0.989 |
| Full Capillary | 304 | 2.3 to 5.6 mmol/L | 1.018
(0.993 to 1.043) | -0.001
(-0.100 to 0.099) | 0.957 |
| Micro Capillary | 304 | 2.3 to 5.6 mmol/L | 0.996
(0.974 to 1.018) | 0.218
(0.130 to 0.307) | 0.963 |
Conclusion: The above results support that in the clinical setting, the K+ performance on the GEM Premier 4000 with the modified K+ sensor is comparable to the GEM Premier 3000/3500 for all sample modes (syringe, full capillary and micro capillary).
Final Conclusion:
Analysis of the validation and verification test results support that the GEM Premier 4000 with the modified K+ sensor membrane is safe, effective, and substantially equivalent to the predicate device.
8
10903 New Hampshire Avenue Silver Spring, MD 20993
Instrumentation Laboratory Co. c/o Carol Marble 180 Hartwell Rd Bedford, MA 01730
MAY - 3 2012
Re: K112995
Trade Name: GEM Premier 4000 with iQM (Intelligent Quality Management), GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox, GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit, GEM CVP 5 (Calibration Valuation Product) tBili Regulation Number: 21 CFR §862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Codes: CEM, CHL, CGZ, CGA, CIG, GKR, GKF, GHS, GLK, GLY, JGS, JFP, JJY, KHP, MQM Dated: March 29, 2012 Received: March 30, 2012
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
9
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 096-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may other back Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use Statement
510(k) Number (if known):
GEM® Premier 4000 with iQM® (Intelligent Quality Management) Device Names: GEM® CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM® CVP 3 and 4 (Calibration Valuation Product) Hematocrit GEM® CVP 5 (Calibration Valuation Product) tBili
Indications for Use:
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metal bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 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)
AND/OR
Ruse Clue
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 七 11 2 9 9 5