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, 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.

GEM System Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 analyzer.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 analyzer.

Device Description

GEM Premier 4000 - Introductions / Modifications:

Addition of total bilirubin (tBili) measurement with whole blood and heparinized plasma on the GEM Premier 4000 performed using spectrophotometric multi-component analysis through the instrument's existing CO-Oximetry module. Following the electrochemical measurements for blood gases, electrolytes and metabolites, a portion of the sample is chemically hemolyzed and brought into an optical cell for the CO-Oximetry measurements and the additional total bilirubin measurement. There were no hardware or mechanical changes required, and no changes to the reagent cartridge (PAK) formulation or sensors. The measurement of total bilirubin was implemented through software.
Expansion of the low-end reportable range for total hemoglobin (tHb) parameter from 5 g/dL to 3 g/dL through additional testing.
Addition of a new 100 uL sample size for total bilirubin and CO-Oximetry mode only.
Automation of fetal hemoglobin correction for CO-Oximetry. Previously the user would input the age of the patient to apply the correction. The new software applies the correction automatically based on the presence of fetal hemoglobin in the sample without user input.
GEM CVP 2 with CO-Ox: This currently marketed external solution for the GEM Premier 4000 will also be value assigned for total bilirubin. No change in formulation.
GEM CVP 5 tBili: An additional external solution for the GEM Premier 4000, containing purified human hemoglobin, stabilizers and biocide in a physiologically buffered matrix, is being introduced at another level of total bilirubin.
GEM System Evaluator: Three-level aqueous buffered bicarbonate solution intended for use with the GEM Premier 4000 analyzer, containing inorganic salts and organic metabolites, dye and biocides; equilibrated with carbon dioxide and oxygen.
GEM Hematocrit Evaluator: Three-level aqueous buffered bicarbonate solution intended for use with the GEM Premier 4000 analyzer, containing inorganic salts and biocides; equilibrated with carbon dioxide and oxygen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the GEM Premier 4000 with iQM, focusing on the total bilirubin (tBili) measurement, based on the provided 510(k) summary:

The document is a 510(k) summary for a medical device. These summaries typically do not contain the full details of clinical studies with extensive data on sample sizes, expert qualifications, or detailed statistical analyses that would be found in a full submission or peer-reviewed publication. Instead, they focus on demonstrating "substantial equivalence" to predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes differences and similarities to predicate devices and states that "data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence... Equivalence is demonstrated through imprecision, method comparison, interference, sample matrix and stability studies, along with software development information."

However, it does provide information about the Tested Range for total bilirubin measurement, which can be seen as an informal performance characteristic:

Characteristic	Acceptance Criteria (Implied / Predicate Performance)	Reported Device Performance (GEM Premier 4000 with tBili)
Total Bilirubin Tested Range	0.0 to 23.5 mg/dL (ABL 735 Analyzer, Predicate)	0.3 to 40.0 mg/dL (GEM Premier 4000 with tBili)
Imprecision	Not explicitly stated, inferred to be comparable to predicate	Demonstrated (details not provided in summary)
Method Comparison	Not explicitly stated, inferred to be comparable to predicate	Demonstrated (details not provided in summary)
Interference	Not explicitly stated, inferred to be comparable to predicate	Demonstrated (details not provided in summary)
Sample Matrix	Not explicitly stated, inferred to be comparable to predicate	Demonstrated (details not provided in summary)
Stability	Not explicitly stated, inferred to be comparable to predicate	Demonstrated (details not provided in summary)

The "acceptance criteria" for the new device appear to be that its performance characteristics (imprecision, method comparison, interference, sample matrix, stability) are substantially equivalent to the predicate devices, and its claimed detection range (0.3 to 40.0 mg/dL) is within acceptable clinical limits and potentially an improvement over the predicate's range.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide details on specific sample sizes used for the various tests (imprecision, method comparison, interference, sample matrix, stability studies). It only states that these studies were performed as part of the Premarket Notification.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, safety and effectiveness studies for 510(k) submissions are typically conducted by the manufacturer, often at their own facilities or contracted labs, using in-house developed protocols. Given the nature of a 510(k) for a laboratory instrument, the data would likely be prospective testing performed specifically for the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is not provided in the 510(k) summary. For a device like a blood gas analyzer measuring total bilirubin, the "ground truth" for method comparison and accuracy studies would typically be established by comparing against a reference method (e.g., a highly accurate laboratory method) rather than human experts interpreting images or clinical cases.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are usually relevant for studies where human expert disagreement on a qualitative assessment (e.g., image interpretation) needs to be resolved. This is not applicable to the type of analytical performance studies described for this device, which focuses on quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is applicable to this device. An MRMC study is relevant for evaluating diagnostic aids that assist human readers in making interpretations (e.g., radiologists interpreting images). This device is an automated in vitro diagnostic instrument that provides quantitative measurements, not an AI assistant for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device, the GEM Premier 4000 with iQM for total bilirubin measurement, is a standalone algorithm/instrument. Its performance is its standalone performance. The measurements it provides are direct outputs from the instrument's spectrophotometric analysis. The iQM system is an internal quality control system that functions automatically without human intervention for real-time error detection and correction.

7. Type of Ground Truth Used

For analytical performance studies of quantitative in vitro diagnostic devices like this one, the "ground truth" (or reference method) is typically:

Reference method comparison: A recognized, highly accurate, and precise analytical method (e.g., a laboratory gold standard method like a direct spectrophotometric method or HPLC for bilirubin) with known accuracy and traceability.
Known concentration samples: Using materials with certified or precisely known concentrations (e.g., calibrators, certified reference materials, spiked samples) for accuracy and linearity.

The summary indicates "method comparison" studies were performed. This implies comparison against another established analytical method.

8. Sample Size for the Training Set

No "training set" information is provided, nor is it directly applicable in the conventional sense of machine learning for image analysis. This device is a spectrophotometric analyzer, not a machine learning model that learns from large datasets of labeled cases in the same way typical AI/ML medical devices do. The software implements the measurement algorithm, and its "training" would be more akin to algorithm development and calibration, using controlled samples with known values.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" in the machine learning sense is not applicable here. The analytical algorithms and instrument calibration would be developed and verified using:

Known chemical standards: Solutions with precisely measured concentrations of the analytes.
Calibrators: Materials specifically designed to calibrate the instrument to known values.
Reference methods: Comparisons against established, highly accurate analytical techniques to ensure the instrument's measurements are correct.

This information would be part of the instrument's design validation and verification, not typically detailed as a "training set ground truth" in a 510(k) summary.

Summary

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Ko93623

Image /page/0/Picture/1 description: The image shows the logos for Werfen Group and Instrumentation Laboratory. The Werfen Group logo is on the left and consists of a globe-like symbol above the text "Werfen Group". To the right of the Werfen Group logo is the Instrumentation Laboratory logo, which consists of a geometric shape and the text "Instrumentation Laboratory".

:JUN 1 8 2010

510(k) Summary

Applicant Contact Information:

Applicant:Address:	Instrumentation Laboratory Co.180 Hartwell RoadBedford, MA 01730
Contact Person:Alternate Contact:Phone Number:Fax Number:	Carol Marble, Regulatory Affairs DirectorGabriella Erdosy, Senior Regulatory Affairs Officer781-861-4467781-861-4207
Preparation Date:	June 8, 2010

Proprietary Names:

GEM® Premier 4000 with iQM® (Intelligent Quality Management)

GEM® CVP 2 (Calibration Valuation Product) with CO-Ox

GEM® CVP 5 (Calibration Valuation Product) tBili

GEM® System Evaluator

GEM® Hematocrit Evaluator

Device Classification:

. Panel: Chemistry (75)
Regulatory Sections: CFR 21 CFR 862.1110 Bilirubin (Total or Direct) Test System . CFR 21 CFR 862.1113 Bilirubin (Total and Unbound) in the Neonate Test System CFR 21 CFR 862.1660 Quality Control Material (Assayed and Unassayed) CFR 21 CFR 864.8625 Hematocrit Control
Class II Classifications: . Class I, Reserved Class I

Class II

Product Codes: CIG . MQM JJY GLK

Predicate Devices:

K991417	ABL 735 Analyzer
K061974	GEM Premier 4000 with iQM and CVF.
K860942	Quantimetrix Bilirubin Control

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Device Descriptions:

GEM Premier 4000 - Introductions / Modifications: .

Addition of total bilirubin (tBili) measurement with whole blood and heparinized plasma on the GEM . Premier 4000 performed using spectrophotometric multi-component analysis through the instrument's existing CO-Oximetry module. Following the electrochemical measurements for blood gases, electrolytes and metabolites, a portion of the sample is chemically hemolyzed and brought into an optical cell for the CO-Oximetry measurements and the additional total bilirubin measurement. There were no hardware or mechanical changes required, and no changes to the reagent cartridge (PAK) formulation or sensors. The measurement of total bilirubin was implemented through software.
Expansion of the low-end reportable range for total hemoglobin (tHb) parameter from 5 g/dL to 3 . g/dL through additional testing.
Addition of a new 100 uL sample size for total bilirubin and CO-Oximetry mode only. .
Automation of fetal hemoglobin correction for CO-Oximetry. Previously the user would input the age . of the patient to apply the correction. The new software applies the correction automatically based on the presence of fetal hemoglobin in the sample without user input.
GEM CVP 2 with CO-Ox: This currently marketed external solution for the GEM Premier 4000 . will also be value assigned for total bilirubin. No change in formulation.
GEM CVP 5 tBili: An additional external solution for the GEM Premier 4000, containing purified . human hemoglobin, stabilizers and biocide in a physiologically buffered matrix, is being introduced at another level of total bilirubin.
GEM System Evaluator: Three-level aqueous buffered bicarbonate solution intended for use with . the GEM Premier 4000 analyzer, containing inorganic salts and organic metabolites, dye and biocides; equilibrated with carbon dioxide and oxygen.
GEM Hematocrit Evaluator: Three-level aqueous buffered bicarbonate solution intended for use . with the GEM Premier 4000 analyzer, containing inorganic salts and biocides; equilibrated with carbon dioxide and oxygen.

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Device Indications for Uses:

GEM Premier 4000 with iQM (Intelligent Quality Management) .
GEM CVP 2 (Calibration Valuation Product) with CO-Ox .
GEM CVP 5 (Calibration Valuation Product) tBili .

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, calcium, glucose, bilirubin and chloride. ionized ----------------------------------------------------------------------------------------------------------------------------------------------------------------------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.

GEM System Evaluator is a three level assayed quality control material intended for evaluating . performance characteristics of pH, pCO2, pQ2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 analyzer.
GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating . performance characteristics of hematocrit on the GEM Premier 4000 analyzer.

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Statement of Technological Characteristics of the Device Compared to Predicate Devices:

Testing supports that the GEM Premier 4000 when used for the measurement of total billirubin (tBili) in conjunction with GEM CVP Level 2 with CO-Ox and GEM CVP 5 tBili and iQM is not materially different in intended use or performance from the ABL 735 Analyzer with traditional QC:

Characteristic	ABL 735 Analyzer(K991417)	GEM Premier 4000 withTotal Bilirubin (tBili)
Test Principle	Spectrophotometry	Same
Sample Type	Whole Blood and Heparinized Plasma	Same
Measured Parameter	Total Bilirubin	Same
Population	Adults and Neonates	Same
Tested Range	0.0 to 23.5 mg/dL	0.3 to 40.0 mg/dL
Controls	External Traditional QC	CVP 2 with CO-Ox and CVP 5 tBili,in conjunction with iQM (IntelligentQuality Management)
Characteristic	GEM CVP 2 with CO-Ox(K061974)	GEM CVP 2 with CO-Ox(Total Bilirubin Claims Added)
Intended Use	CalibrationValuationExternalused to complete theProductcalibration process of the GEMPremier 3000 and GEM Premier 4000analyzers prior to use with patientsamples.NOTE: High pH, pO2. Na, K, CI`,	Same; except assigned with a hightotal bilirubin value
	COHb, MetHb, HHb and low pCO2,Ca , glucose, lactate, tHb and O2Hbvalues.
Formulation	Aqueous buffered bicarbonate solutioncontaining inorganic salts and organicmetabolites, stabilizer, dye andbiocides; equilibrated with preciseconcentrations of carbon dioxide andoxygen	Same; no change in formulation
Storage	Unopened ampules are stable until theexpiration date shown on the labelwhen stored at 2-8℃, or up tomonths at room temperature00(15-25℃), providing storage does notexceed the expiration date. DO NOTFREEZE.	Same; no change in formulation

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Statement of Technological Characteristics of the Device Compared to Predicate Devices (Cont.):

Characteristic	Quantimetrix QC Bilirubin(K860942)	GEM CVP 5 tBili
Intended Use	Intended as a means of monitoringvarious bilirubin assay methods tovalidate quantitation of patient samples.NOTE: Two total bilirubin levels (lowand high).	External Calibration Valuation Productused to complete the calibration processof the GEM Premier 4000 analyzerprior to use with patient samples fortotal bilirubin (tBili) testing.NOTE: Low total bilirubin value.
Formulation	Prepared from purified bilirubin in ahuman protein base. Stabilizers andpreservatives have been added.	Purified human hemoglobin, stabilizersand biocide in a physiologicallybuffered solution.
Storage	Store at 2-8°C	Store at 2-8°C

Characteristic	GEM CVP 1 and 2 with CO-Ox(K061974)	GEM System Evaluator
Intended Use	External Calibration Valuation Productused to complete the calibration processof the GEM Premier 3000 and GEMPremier 4000 analyzers prior to usewith patient samples.NOTE: Two levels each for pH, pCO2,pO2, Electrolytes, Metabolites, tBili(CVP 2 only) and CO-Oximetry.	Three-level assayed quality controlmaterial for evaluating performancecharacteristics of pH, pCO2, pO2,Electrolytes, Metabolites, TotalBilirubin (tBili) and CO-Oximetry onthe GEM Premier 4000 analyzer.
Formulation	Aqueous buffered bicarbonate solution	Same
Stability	2-8°C until expiration	2-8°C until expiration
	15-25°C for 8 months	15-25°C for 4 months

Characteristic	GEM CVP 3 and 4 Hematocrit(K061974)	GEM Hematocrit Evaluator
Intended Use	External Calibration Valuation Productused to complete the calibration processof the GEM Premier 3000 and GEMPremier 4000 analyzers prior to usewith patient samples.	Three-level assayed quality controlmaterial for evaluating performancecharacteristics of hematocrit on theGEM Premier 4000 analyzer.
	NOTE: Two levels for hematocrit.
Formulation	Aqueous buffered bicarbonate solution	Same
Stability	15-25°C until expiration	Same

Substantial Equivalence:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems and quality controls already in commercial distribution. Equivalence is demonstrated through imprecision, method comparison, interference, sample matrix and stability studies, along with software development information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Instrumentation Laboratory Company c/o Ms. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, MA 01730

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN : 8 2010

Re: K093623

Trade Name: GEM® Premier 4000 with iQM® (Intelligent Quality Management), GEM® CVP 2 (Calibration Valuation Product) with CO-Ox, GEM® CVP 5 (Calibration Valuation Product) tBili, GEM System Evaluator, GEM Hematocrit Evaluator Regulation Number: 21 CFR §862.1110 Regulation Name: Bilirubin (Total or Direct) Test System Regulatory Class: Class II Product Codes: CIG, MQM, JJY, GLK Dated: June 02, 2010 Received: June 03, 2010

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).

、な

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office 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) 796-5760. 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 Small 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 C. Harper, Ph.D. 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

4093623

510(k) Number (if known):

GEM® Premier 4000 with iQM® (Intelligent Quality Management) Device Names: GEM® CVP 2 (Calibration Valuation Product) with CO-Ox 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. BCO2 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.

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 iOM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH. blood gases, electrolytes, total bilirubin. CO-Oximetry and hematoorit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iOM program monitors the status of the system during the cartridge use life.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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 (O[VD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093623

Attachment G

GEM Premier 4000 System 510(k)

Page I of 2

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Indications for Use Statement

K093623

510(k) Number (if known):

GEM® System Evaluator Device Name: GEM® Hematocrit Evaluator

Indications for Use:

GEM System Evaluator is a three-level assayed quality control material intended for evaluating . performance characteristics of pH, pCO2, pO2, Electrolytes, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 analyzer.
GEM Hematocrit Evaluator is a three-level assayed quality control material for evaluating . performance characteristics of hematocrit on the GEM Premier 4000 analyzer.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093623

Attachment G

GEM Premier 4000 System 510(k)

Page 2 of 2

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.