ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

Device Description

ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide < 0.1 % R2: Hexokinase ≥ 8 500 U/L, G-6-PDH ≥ 8 500 U/L, Magnesium salt 20 mmol/L, Sodium azide < 0.1 % mmol/L.

ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be neqative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

AI/ML Overview

The provided document describes the analytical performance of the ELITech Clinical Systems GLUCOSE HK SL reagent, ELICAL 2 calibrator, and ELITROL I/II controls. It does not describe an AI/ML powered device, therefore no information is available regarding expert consensus, MRMC studies, or multi-reader performance. The study described focuses on demonstrating substantial equivalence to predicate devices for in vitro diagnostic use.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria implicitly through the study design (e.g., acceptance bias for interference studies) and generally through comparison to a predicate device. Performance is reported through various analytical studies.

ELITech Clinical Systems GLUCOSE HK SL Reagent Performance Summary:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Precision (CV%)	Not explicitly stated as acceptance criteria, but predicate device performance or general IVD standards for reproducibility would be implied.	Serum: - Level 1 (45.5 mg/dL): Within-run CV% 1.1, Total CV% 2.0 - Level 2 (119.5 mg/dL): Within-run CV% 0.9, Total CV% 1.7 - Level 3 (251.5 mg/dL): Within-run CV% 0.9, Total CV% 2.0 - Level 4 (522.5 mg/dL): Within-run CV% 0.4, Total CV% 1.8 Urine: - Level 1 (18.0 mg/dL): Within-run CV% 0.9, Total CV% 2.0 - Level 2 (204.4 mg/dL): Within-run CV% 0.7, Total CV% 1.7 - Level 3 (497.4 mg/dL): Within-run CV% 0.6, Total CV% 1.7
Linearity/Assay Range	Serum: Demonstrated linearity for reported range (20 - 720 mg/dL). Urine: Demonstrated linearity for reported range (10 - 720 mg/dL).	Serum: Linear range: 20 - 720 mg/dL (y = 1.025x - 2.0 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.0 mg/dL). Auto-dilution to 3600 mg/dL. Urine: Linear range: 10 - 720 mg/dL (y = 1.0155x - 1.6 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 3.5 mg/dL). Auto-dilution to 3600 mg/dL.
On-board Stability	28 days for the reagent.	Reagent: 28 days on-board. Shelf-life: 27 months (real-time studies for 36 months).
Limit of Detection (LoD)	Not explicitly stated, but clinical relevance and comparison to predicate device would be implicit.	Serum: 0.3 mg/dL Urine: 0.2 mg/dL
Limit of Quantification (LoQ)	Serum: Acceptable Total Error ≤ 0.32 mg/dL; value must be ≥ LoD. Urine: Acceptable Total Error ≤ 0.8 mg/dL; value must be ≥ LoD.	Serum: 5.00 mg/dL Urine: 5.00 mg/dL
Interference/Analytical Specificity	Accepted bias of ±10% in sample pools with low (50.0 mg/dL for serum, 18.0 mg/dL for urine) or high (120.0 mg/dL for serum, 200.0 mg/dL for urine) nominal activity. Specific interferent concentrations are also listed in the table.	Serum: No significant interference up to listed concentrations for unconjugated bilirubin (30.0 mg/dL), conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), triglycerides (600 mg/dL - note: negative bias observed at higher levels), ascorbic acid (20.0 mg/dL), uric acid (20.0 mg/dL), methyl dopa (2.0 mg/dL), L-dopa (30.0 mg/dL), Tolazamide (50.0 mg/dL), and acetaminophen (30 mg/dL). Urine: No significant interference up to listed concentrations for conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), uric acid (100 mg/dL), and urea (6000 mg/dL). No significant interference for pH (2.5 to 12.0) and specific gravity (1.000 to 1.030).
Method Comparison (Correlation)	Demonstrate substantial equivalence to the predicate device (Roche Diagnostics Cobas C111 Glucose HK).	Serum: Against Cobas C111: y = 1.008 x + 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.7 mg/dL. Urine: Against Cobas C111: y = 0.996 x - 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 3.5 mg/dL. Plasma (Lithium Heparin): y = 1.001x - 0.7 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 1.9 mg/dL. Plasma (Sodium Fluoride/Oxalate): y = 1.016x - 0.9 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 7.0 mg/dL.

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

Precision Studies:
- Serum: 80 measurements for each of 4 levels (total of 320 measurements). Samples were human sera and control sera.
- Urine: 80 measurements for each of 3 levels (total of 240 measurements). Samples were urine pools.
- Provenance: Not specified, but likely from laboratory samples as part of a method validation. Neither retrospective nor prospective status is explicitly stated, but analytical performance studies are generally conducted prospectively on prepared samples or collected patient samples.
Linearity Studies:
- Serum: 11 levels of mixed samples.
- Urine: 11 levels of mixed samples.
- Provenance: Not specified, but likely prepared in a laboratory.
Interference Studies:
- Serum: Two serum sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations (e.g., 9 for triglycerides, 7 for bilirubin). Each point measured in triplicate per run. Two levels of control materials also tested.
- Urine: Two urine sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations. Each point measured in triplicate per run. Two levels of control materials also tested.
- Provenance: Not specified, but laboratory prepared spiked samples.
Method Comparison Studies (Test Set):
- Serum: 100 serum patient samples (ranging from 20.5 to 707.5 mg/dL).
- Urine: 40 urine patient samples (with glacial acetic acid as preservative, ranging from 10.1 to 703.9 mg/dL).
- Plasma (Lithium Heparin): 40 plasma patient samples (ranging from 24.3 to 710.1 mg/dL).
- Plasma (Sodium Fluoride/Oxalate): 40 plasma patient samples (ranging from 21.2 to 701.4 mg/dL).
- Provenance: "patient samples" implies retrospective or prospectively collected clinical samples. The country of origin is not specified but given the submitter's address (France and USA), it could be either.

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

Not applicable, as this is an in-vitro diagnostic test measuring a quantitative analyte (glucose). The "ground truth" for the test set is established by the reference method (Roche Diagnostics Cobas C111 Glucose HK) or known values/concentrations for engineered samples in analytical studies.

4. Adjudication Method for the Test Set:

Not applicable, as this is an in-vitro diagnostic test. Results are quantitative measurements compared against a reference method or known values, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

Not applicable, as this is an in-vitro diagnostic test. There is no human reader involvement in interpreting the device's quantitative output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are all "standalone" in the sense that they evaluate the analytical performance of the device (reagent, calibrator, controls) on an automated analyzer (ELITech Clinical Systems Selectra ProM Analyzer) without human intervention in the result determination process.

7. The Type of Ground Truth Used:

Known concentrations: For linearity, LoD/LoQ, and interference studies, samples were prepared to have known or target concentrations of glucose and interferents.
Reference method/device: For method comparison studies, the predicate device (Roche Diagnostics Cobas C111 Glucose HK) was used as the comparative "ground truth" for patient samples.
NIST Traceability: For calibration, the glucose value assigned to the calibrator (ELICAL 2) is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML powered device, so there is no "training set." The device performance is based on the chemical reagent's properties and the analyzer's measurement capabilities.

9. How the Ground Truth for the Training Set was Established:

Not applicable (no training set).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2016

ELITECHGROUP TERRY TRIMINGHAM REGULATORY ASSOCIATE 21720 23RD DRIVE SE, SUITE 150 BOTHELL, WA 98021

Re: K153644 Trade/Device Name: ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II

Product Code: CFR, JIX, JJY Dated: July 25, 2016 Received: July 26, 2016

Dear Terry Trimingham:

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 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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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Indications for Use

510(k) Number (if known) K153644

Device Name

ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

Indications for Use (Describe)

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.

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)

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K153644

510(k) Summary Submitted in accordance with CFR 807.92

ELITech Clinical Systems GLUCOSE HK SL

1.	Date:	August 16, 2016
2.	Submitter:	ELITech Clinical Systems SASZone Industrielle61500 SEESFRANCE
3.	Contact Person:	Terry Trimingham21720 23rd Dr SE, Suite 150Bothell, WA 98021Phone: 425-482-5190Fax: 425-482-5550Email: t.trimingham@elitechgroup.com
4.	Device Description:Classification	ELITech Clinical Systems GLUCOSE HK SLClass IICFR Glucose HKClinical Chemistry21 CFR 862.1345
	Device Description:Classification	ELITech Clinical Systems ELICAL 2Class IIJIXClinical Chemistry21 CFR 862.1150
	Device Description:Classification	ELITech Clinical Systems ELITROL I and ELITROL IIClass IJJYClinical Chemistry21 CFR 826.1660
5.	Predicate Device:	K951595Roche DiagnosticsCobas C111 Glucose HK

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6. Intended Use

Reagent:	ELITech Clinical Systems GLUCOSE HK SL is intendedfor the quantitative in vitro diagnostic determination ofglucose in human serum, plasma and urine on ELITechClinical Systems Selectra Pro Series Analyzers. Glucosemeasurements are used in the diagnosis and treatment ofcarbohydrate metabolism disorders including diabetesmellitus and idiopathic hypoglycemia, and of pancreaticdiseases.
Calibrators:	ELITech Clinical Systems ELICAL 2 is a multi-parametriccalibrator for in vitro diagnostic use in the calibration ofquantitative ELITech Clinical Systems methods onELITech Clinical Systems Analyzers.
Controls:	ELITech Clinical Systems ELITROL I and ELITROL II aremultiparametric control sera for in vitro diagnostic use inquality control of quantitative ELITech Clinical Systemsmethods on ELITech Clinical Systems Analyzers.

Special conditions for use statement(s):

This device is intended for prescription use and in vitro diagnostic only.

CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. It is not intended for use in Point of Care settings.

Reagent Special instrument requirements:

For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM Analyzer.

Device Descriptions 7.

8. Substantial Equivalence Information Assay (reagent)

1. Predicate Device Name
Roche Diagnostics Cobas C111 Glucose HK
1. K951595
1. Comparison with predicate

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Similarities

Parameter	New DeviceELITech Clinical SystemsGLUCOSE HK SL	Predicate DeviceROCHE DIAGNOSTICS GLUCOSE HK,K951595
Intended Use	ELITech Clinical Systems GLUCOSEHK SL is intended for the quantitativein vitro diagnostic determination ofglucose in human serum, plasma andurine on ELITech Clinical SystemsSelectra Pro Series Analyzers.	In vitro test for the quantitativedetermination of glucose in humanserum, plasma and urine on the Cobasc 111 system.
Indication forUse	Glucose measurements are used inthe diagnosis and treatment ofcarbohydrate metabolism disordersincluding diabetes mellitus andidiopathic hypoglycemia, and ofpancreatic diseases.	Glucose measurements are used in thediagnosis and treatment ofcarbohydrate metabolism disordersincluding diabetes mellitus, neonatalhypoglycemia, and idiopathichypoglycemia, and of pancreatic isletcell tumors.
Sample Type	Serum, Plasma, Urine	Same
AssayTechnology	Enzymatic(hexokinase).UV.Endpoint.	Enzymatic reference method withhexokinase
Composition	Reagent :R1: Pipes buffer, pH 7.60 80 mmol/L,NAD 4.1 mmol/L, ATP 2.2 mmol/L,Sodium azide < 0.1 %R2: Hexokinase ≥ 8 500 U/L, G-6-PDH≥ 8 500 U/L, Magnesium salt 20mmol/L, Sodium azide < 0.1 %.	R1: TRIS buffer: 100 mmol/L, pH 7.8;Mg2+: 4 mmol/L; ATP: ≥ 1.7 mmol/L;NADP: ≥ 1.0 mmol/L; preservative.SR: HEPES buffer: 30 mmol/L, pH 7.0;Mg2+: 4 mmol/L; HK (yeast): ≥ 130µkat/L; G-6-PDH (E. coli): ≥ 250 µkat/L;preservative.
Appearanceof reagents	Liquid form, ready to use	Same

Differences

Parameter	New DeviceELITech Clinical SystemsGLUCOSE HK SL	Predicate DeviceROCHE DIAGNOSTICS GLUCOSE HK,K951595
Assay Format	8 x 25 mL	4 x 100 mL
Storage &Expiry	Store at 2-8°C and protect from light.	Shelf life at 2-8°C.
	The reagent is stable until the expirydate stated on the label.	See expiration date on reagent.
Assay Range	Serum, Plasma : 20 - 720 mg/dLUrine: 10 - 720 mg/dL	Serum, Plasma, Urine : 1.98 - 720mg/dL
Instrument	Selectra Series Analyzers	Cobas C111
Reference	Serum/ Plasma :	Serum / Plasma :74 - 109 mg/dL (4.11 - 6.05 mmol/L)
Parameter	New DeviceELITech Clinical SystemsGLUCOSE HK SL	Predicate DeviceROCHE DIAGNOSTICS GLUCOSE HK,K951595
Values	74 - 106 mg/dL4.1 - 5.9 mmol/LUrine :<0.5 g/day 1-15 mg/dL<2.78 mmol/day 0.1 - 0.8 mmol/L	Urine :1st Morning Urine: 6 - 20 mg/dL (0.3 –1.1 mmol/L)24 Hour Urine: 6 - 17 mg/dL (0.3 – 0.96mmol/L)(Average of 1350 mL Urine/24 h)
Controls	Recommended quality controlmaterial (not included):ELITech Clinical Systems ELITROL I(Normal control)ELITech Clinical Systems ELITROL II(Pathologic control)	Recommended quality control material(not included):Precinorm U or Precinorm U plus andPrecipath U or Precipath U plus
Calibrator	Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2	Recommended calibration material (notincluded):Calibrator f.a.s
Limit ofDetection	Serum: 0.3 mg/dL (0.02 mmol/L)Urine: 0.2 mg/dL (0.01 mmol/L)	Serum, Plasma & Urine: 1.98 mg/dL(0.11 mmol/L)
Interferences-Serum	Unconjugated bilirubin: Nosignificant interference up to30.0 mg/dL (513 µmol/L).Conjugated bilirubin: No significantinterference up to 29.5 mg/dL(504 µmol/L).Hemoglobin: No significantinterference up to 500 mg/dL.Triglycerides: No significantinterference up to 600 mg/dL (5.95mmol/L). At a level of ~1300mg/dL ofTriglycerides, a negative bias of 32%is observed at 50 mg/dL of glucose,and a negative bias of 19% isobserved at 120mg/dL of glucoseAscorbic acid: No significantinterference up to 20.0 mg/dL.(1136 µmol/L)Uric acid: No significant interferenceup to 20.0 mg/dL.(1190 µmol/L)Methyl dopa: No significantinterference up to 2.0 mg/dL.L-dopa: No significant interferenceup to 30.0 mg/dL.Tolazamide: No significantinterference up to 50.0 mg/dL.Acetaminophen: No significantinterference up to 30 mg/dL.(1.98 mmol/L)	Icterus: No significant interference upto an I index of 60 for conjugated andunconjugated bilirubin approximateconjugated and unconjugated bilirubinconcentration: 1026 µmol/L or60 mg/dL).Hemolysis: No significant interferenceup to an H index of 1000 (approximatehemoglobin concentration: 621 µmol/Lor 1000 mg/dL).Lipemia (Intralipid): No significantinterference up to an L index of 2000.There is poor correlation between the Lindex (corresponds to turbidity) andTriglycerides concentration.Drugs: No interference was found attherapeutic concentrations usingcommon drug panels.
Parameter	New DeviceELITech Clinical SystemsGLUCOSE HK SL	Predicate DeviceROCHE DIAGNOSTICS GLUCOSE HK,K951595
Interferences -Urine	Conjugated bilirubin: No significantinterference up to 29.5 mg/dL(504 µmol/L).Hemoglobin: No significantinterference up to 500 mg/dLUric Acid: No significant interferenceup to 100 mg/dL.(5.95 mmol/L)Urea: No significant interference upto 6000 mg/dL.(999 mmol/L)pH: No significant interferencebetween 2.5 to 12.0Specific gravity: No significantinterference between 1.000 to 1.030	No data
Calibrationfrequency	Calibration frequency: 28 daysRecalibrate when reagent lotschange, when quality control resultsfall outside the established range,and after a maintenance operation.	Each lot and as required followingquality control procedures.

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Control Sera

1. Predicate Device Name:
Roche Diagnostics Precinorm U and Precipath U
1. K041227
1. Comparison with predicate

Similarities and Differences

ltem	ELITech Clinical Systems DeviceELITROL I and ELITROL II	PredicateRoche Diagnostics Precinorm U andPrecipath U (K041227)
IntendedUse/Indications forUse	ELITech Clinical Systems ELITROL I andELITROL II are multi-parametric controlsera for in vitro diagnostic use in qualitycontrol of quantitative ELITech ClinicalSystems methods on ELITech ClinicalSystems Analyzers.	Precinorm U is for use in quality controlby monitoring accuracy and precision forthe quantitative methods as specified inthe value sheets.Precipath U is for use in quality controlby monitoring accuracy and precision forthe quantitative methods as specified inthe value sheets.
Format	Lyophilized human sera with constituentsadded as required to obtain definedcomponent levels	Same
Levels	Two Levels (Level I and Level II)	Same
Stability	Lyophilized:To store at 2-8°C and protected from lightuntil the expiry dateAfter reconstitution, the stabilities are :- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C (whenfrozen once)	Same

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Calibrator

1. Predicate Device Name:
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
1. K033501
1. Comparison with predicate

Similarities and Differences

Item	ELITech Clinical Systems DeviceELICAL 2	PredicateRoche Calibrator for AutomatedSystems (C.f.a.s.) K033501
IntendedUse/Indications forUse	ELITech Clinical Systems ELICAL 2 is amultiparametric calibrator for in vitrodiagnostic use in the calibration ofquantitative ELITech Clinical Systemsmethods on ELITech Clinical SystemsAnalyzers.	Calibrator for automated systems(C.f.a.s.) is for use in the calibration ofquantitative Roche methods on Rocheclinical chemistry analyzers asspecified in the value sheets.
Format	Lyophilized calibrator based on humanserum with constituents added asrequires to obtain desired componentlevels	Same
Level	Single Level	Same
Stability	Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are:- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C (whenfrozen once)	Same

9. Standard/Guidance Document Reference

CLSI EP5-A2 (Evaluation of precision performance of Quantitative . MeasurementMethods: Approved Guideline - Second Edition). CLSI protocol EP6-A (Evaluation of the Linearity of Quantitative Measurement Procedure: A Statistical Approach; Approved Guideline).
CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
. CLSI protocol EP7-A2 (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition) used for recommended sample concentrations.
CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient . Samples ; Approved Guideline - Second edition).
. NF EN 13640:2002 "Stability testing of in vitro diagnostic reagents
Test Principle: 10.

The reaction of glucose with ATP produces Glucose –6-phosphate which in presence of NAD+ will produce D-Gluconate-6-phosphate + NADH + H*

The increase of absorbance is directly proportional to the glucose concentration.

Performance Characteristics - Analytical Performance 11.

a. Precision/Reproducibility

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Precision

The precision of the device was determined in accordance to CLSI EP05-A2 protocol (Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition).

Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 4 levels of samples on 2 instruments during twenty operating days according to CLSI EP05-A2 protocol. The results are presented in the table below:

Level	n	Mean (mg/dL)	Precision %
			Within-run CV%	Total CV%
Level 1	80	45.5	1.1	2.0
Level 2	80	119.5	0.9	1.7
Level 3	80	251.5	0.9	2.0
Level 4	80	522.5	0.4	1.8

Serum Level 1,2 and 4 are human sera, level 3 is a control sera

Urine

Level 1 ,2 and 3 are urine pool

Level	n	Mean (mg/dL)	Precision %
			Within-run CV%	Total CV%
Level 1	80	18.0	0.9	2.0
Level 2	80	204.4	0.7	1.7
Level 3	80	497.4	0.6	1.7

b. Linearity/assay reportable range

The linearity study of ELITech Clinical Systems GLUCOSE HK SL was performed according to CLSI protocol EP06-A (Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline).

Serum:

The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (726.6 mg/dL) and a sample with low value (20.0 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.

Regression analysis of the results yielded the following: y = 1.025x - 2.0 mg/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.0 mg/dL

From this study, a measuring range from 20 - 720 mg/dL has been determined.

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Urine:

The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (724.9 mg/dL) and a sample with low value (10.1 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.

Regression analysis of the results yielded the following: y = 1.0155x - 1.6 mg/dL. r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 3.5 mg/dL

From this study, a measuring range from 10 - 720 mg/dL has been determined.

Auto-dilution 1 to 5 allows the use of the ELITech Clinical Systems GLUCOSE HK SL with analyte activities up to 3600 mg/dL.

c. Traceability

For calibration, a multi-parametric calibrator, most recently cleared under K151552, named ELITech Clinical Systems ELICAL 2 (manufactured by ELITech Clinical Systems SAS under product code CALI-0580) must be used. Traceability of the assigned value for all constituents in this calibrator, including the qlucose value assigned to calibrate ELITech Clinical Systems GLUCOSE HK SL. is included in its labeling. ELITech Glucose Hexokinase method is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).

d. Stability

On board stability for the ELITech Clinical Systems GLUCOSE HK SL was established by real time studies on the ELITech Clinical Systems Selectra ProM Analyzer. The on-board stability of the reagent is 28 days. The shelf-life of GLUCOSE HK SL reagent has been followed in real time for 36 months on 3 different batches; a real-time stability of 27 months is claimed.

Serum control material is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems ELITROL I and ELITROL II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.

Calibrator material is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling states that the Elical 2 should be stored tightly capped and protected from light when not in use.

Value Assignment

Elitrol I and II are value assigned using multiple ELITech Clinical Systems Selectra ProM Series Analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.

Elical 2 is tested against predetermined values on one ELITech Clinical Systems Selectra ProM Series Analyzers using the GLUCOSE HK SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.

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e. Detection limit

Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).

Serum

Limit of Detection:

The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCI 0.9% to obtain a concentration of approximately 5 mg/dL.

The data are not Gaussian, so LoD= LoB + Dsg (where Dsg is determined by calculating the median minus the 5th percentile of the low activity sample distribution).

Limit of Detection = 0.3 mg/dL.

Limit of Quantification:

The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.

Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.32 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.

Limit of Quantification = 5.00 mg/dL.

Urine

Limit of Detection:

The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.

The data are not Gaussian, so LoD= LoB + Ds (where Ds & is determined by calculating the median minus the 5th percentile of the low activity sample distribution).

Limit of Detection = 0.2 mg/dL.

Limit of Quantification

Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.8 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.

Limit of Quantification =5.00 mg/dL.

f. Interference/analytical specificity

Serum

Interferences due to unconjugated bilirubin, conjugated bilirubin, hemoglobin, triglycerides, ascorbic acid, uric acid, methyl dopa, L-dopa, Tolazamide and acetaminophen were investigated following the recommended sample levels in CLSI EP07-A2 protocol

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(Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).

For each potential interferent tested, 2 serum sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 we
-1* pool: low activity at nominal 50.0 mg/d
-200 pool: high activity at nominal 120.0 mg/ those specified in Appendix B of EP7-A2 were prepared:

1st pool: low activity at nominal 50.0 mg/dL

pool: high activity at nominal 120.0 mg/dL

Aliquots of each of the serum sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.

Interferent	Test range	Number of differentconcentrations tested
Triglycerides	up to 3000 mg/dL	9
Unconjugated bilirubin	up to 30.0 mg/dL	7
Conjugated bilirubin	up to 29.5 mg/dL	7
Hemoglobin	up to 500 mg/dL	9
Uric acid	up to 20.0 mg/dL	7
L-dopa	up to 30 mg/dL	7
Ascorbic acid	up to 20 mg/dL	7
Methyl dopa	up to 2.0 mg/dL	6
Tolazamide	up to 50 mg/dL	6
Acetaminophen	up to 30 mg/dL	7

Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the calibration.

For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (50.0 mg/dL) or high (120.0 mg/dL) nominal activity.

The results of testing interferences are the following:

Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL conjugated bilirubin, -500 mg/dL hemoglobin, 600 mg/dL triglycerides (At a level of ~1300mg/dL of Triglycerides, a negative bias of 32% is observed at 50 mg/dL of glucose, and a negative bias of 19% is observed at 120mg/dL of glucose), 20.0 mg/dL ascorbic acid, 20.0 mg/dL uric acid. 2.0 mg/dL methyl dopa, 30.0 Tolazamide and 30 mg/dL acetaminophen do not show any significant interference for each substance.
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.

The following statement will also be included in the labeling:

Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).

Young, D. S., Effects of drugs on clinical laboratory tests, 4th Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin Belg., (2004), 59, 263.

Urine

Interferences due to Conjugated bilirubin, Hemoglobin, Uric Acid and Urea were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). Also tested were pH and specific gravity.

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For each potential interferent tested, 2 urine sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 were prepared:

-18t pool: low activity at nominal 18.0 mg/dL
-20d pool: high activity at nominal 200.0 mg/dL

Aliquots of each of the urine sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.

Interferent	Test range	Number of differentconcentrations tested
Conjugated bilirubin	up to 29.5 mg/dL	7
Hemoglobin	up to 500 mg/dL	9
Uric acid	up to 100 mg/dL	6
Urea	up to 6000 mg/dL	6
pH	between 2.5 to 12.0	7
Specific Gravity	between 1.000 to 1.030	6

Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the reagents.

For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (18.0 mg/dL) or high (200.0 mg/dL) nominal activity.

The results of testing interferences are the following:

Concentration up to 29.5 mg/dL conjugated bilirubin, 500 mg/dL hemoglobin, 100 mg/dL uric acid and 6000 mg/dL urea do not significant interference for each substance.

The following statement will also be included in the labeling:

Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).

-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995).

Performance Characteristics - Comparison Studies 11.

a. Method comparison

Serum

A correlation study was performed between ELITech Clinical Systems GLUCOSE HK SL reagent on a Selectra ProM Analyzer and GLUC2 (Glucose HK) reagent on Cobas C111 analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

This study was performed using 100 serum patient samples from 20.5 to 707.5 mg/dL over a span of 5 days.

Regression analysis of the results vielded the following: v = 1.008 x + 0.4 ma/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.7 mg/dL.

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Urine

This study was performed using 40 urine patient samples (with glacial acetic acid as preservative) from 10.1 to 703.9 mg/dL over a span of 2 days.

Regression analysis of the results yielded the following: y = 0.996 x - 0.4 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 3.5 mg/dL

b. Comparison study: Matrix comparison

40 plasma patients (in lithium heparin samples, ranging from 24.3 to 710.1 mg/dL), were tested on ELITech Clinical Systems Selectra ProM Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

Regression analysis of the results yielded the following:

y = 1.001x - 0.7 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 1.9 mg/dL

40 plasma patients (in sodium fluoride/ oxalate, ranging from 21.2 to 701.4 mg/dL), were tested on ELITech Clinical Systems Selectra ProM Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

Regression analysis of the results yielded the following:

y = 1.016x - 0.9 mg/dL r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 7.0 mg/dL

c. Expected values/Reference Range

As indicated in the instructions for use for ELITech Clinical Systems GLUCOSE HK SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.

Serum/ Plasma :

74 - 106 mg/dL 4.1 – 5.9 mmol/L

Urine :

<0.5 g/day 1-15 mg/dL <2.78 mmol/day 0.1 - 0.8 mmol/L

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These reference values are from:

Wu, A. H. B., Clinical quide to laboratory tests, 4006 Ed., (W.B. Saunders eds. Philadelphia USA), (2006), 444

d. Clinical Studies:

Not applicable

e. Clinical Cut-off:

Not applicable

12. Conclusion

Versus the predicate, the new device has the same indications for use on the same specimen types. The information on the principle and performance of the test device shown in the above table, gained in laboratory evaluation of the device and contained in this premarket notification, shows no deviation in safety or effectiveness, and supports a decision that the test device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.