(260 days)
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No
The summary describes a standard clinical chemistry analyzer and reagent kit using photometric detection. There is no mention of AI, ML, or any computational methods beyond basic data processing for calculating analyte concentrations.
No.
The device is used for the quantitation of glucose in human body fluids, which is used in the diagnosis and treatment of carbohydrate metabolism disorders. It is an in vitro diagnostic device, not a therapeutic device.
Yes
Explanation: The Alinity c Glucose Reagent Kit and the Alinity c System are explicitly stated to be "used in the diagnosis and treatment of carbohydrate metabolism disorders". The Alinity c System is also described as a "clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids," which is characteristic of diagnostic devices.
No
The device description clearly outlines physical components including reagent kits, calibrator kits, and a fully automated chemistry analyzer with robotic sample handling and photometric detection technology. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Alinity c Glucose Reagent Kit is used for the "in vitro determination of analytes in body fluids" and for the "quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF)". This clearly indicates testing performed outside of the living body on biological samples.
- Device Description: The description details a "clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids."
- Performance Studies: The performance studies involve testing human serum, plasma, urine, and CSF samples, which are biological specimens.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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.
The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.
Product codes
CFR, JJE
Device Description
Alinity c Glucose Reagent Kit: The kit contains Reagent 1 (R1) with active ingredients ATP·2Na, NAD, G-6-PDH, Hexokinase, and preservative sodium azide. Volumes per cartridge are either 26.5 mL for 400 tests or 66.4 mL for 1100 tests. Each kit contains 10 cartridges. The reagent container is made of polypropylene and is black in color, with a High Density Polyethylene black closure.
Alinity c Multiconstituent Calibrator Kit: This kit contains human-based matrix calibrators (Cal 1 and Cal 2) with multiple analytes including glucose. Sodium azide is present as a preservative. The calibrators are standardized using NIST SRM 965 and the ID-GC/MS reference method for glucose.
Alinity c System: The Alinity c System is a fully automated chemistry analyzer designed for random and continuous access, as well as priority and automated retest processing. It uses photometric and potentiometric detection technology to measure sample absorbance for the quantification of analyte concentration. It features a robotic sample handler for transport with random and continuous access, autoretest capability, and priority and batch sample loading. The system also has an on-board storage area cooler for evaporation control and continuous reagent access.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Within-Laboratory Precision (20-Day)
- Alinity Glucose Reagent Kit - Serum Samples: Precision was evaluated based on CLSI document EP05-A2. Samples included Control Level 1 (n=264), Control Level 2 (n=264/263), Control Level 3 (n=264/260), Panel A (n=527), Panel B (n=528), and Panel C (n=523). Within-laboratory imprecision (within-run, between-run, and between-day) was acceptable at ≤ 5 %CV for samples targeted between 80 to 281 mg/dL.
- Alinity Glucose Reagent Kit - Urine Samples: Precision was evaluated based on CLSI document EP05-A2. Samples included Control Level 1 (n=264/263), Control Level 2 (n=260/264), Panel A (n=527), Panel B (n=526), Panel C (n=528), and Panel D (n=525). Within-laboratory imprecision was acceptable at ≤ 6 %CV for urine samples targeted between 30 to 306 mg/dL.
- Alinity Glucose Reagent Kit - Cerebrospinal Fluid (CSF) Samples: Precision was evaluated based on CLSI document EP05-A2. Samples included Control Level 1 (n=264), Control Level 2 (n=264/263), Panel A (n=527), Panel B (n=528), Panel C (n=527), and Panel D (n=526). Within-laboratory imprecision was acceptable at ≤ 5 %CV for CSF samples targeted between 29 to 60 mg/dL.
Accuracy
- Alinity c Glucose Reagent Kit - Serum: Tested a minimum of 1 level of a NIST standard (SRM 965b, Glucose in Human Serum) at or near the medical decision point. NIST levels tested were 33.08 mg/dL, 75.56 mg/dL, 118.5 mg/dL, and 294.5 mg/dL (n=22 for each level). Bias ranged from 0 to 11 mg/dL, and %Bias from 0.2% to 3.8%. Total Error ranged from 0.8 to 14.0 mg/dL, and % Total Error from 2.1% to 4.7%.
Limit of Blank, Limit of Detection, and Limit of Quantitation
- Alinity c Glucose Reagent Kit - Serum/Plasma, Urine/CSF Samples: Studied based on CLSI document EP17-A2.
- Serum/Plasma: LoB = 0.33 mg/dL, LoD = 0.55 mg/dL, LoQ = 2.25 mg/dL.
- Urine/CSF: LoB = 0.23 mg/dL, LoD = 0.40 mg/dL, LoQ = 0.86 mg/dL.
- LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.
- LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.
- LoQ is the lowest concentration at which a maximum allowable precision of 20 %CV was met (n ≥ 60 replicates of low-analyte level samples).
Linearity
- Alinity c Glucose Reagent Kit - Serum/Plasma, Urine/CSF Samples: Determined based on CLSI document EP06-A.
- Serum/Plasma: Mean observed linear range concentrations ranged from 0 to 828 mg/dL.
- Urine: Mean observed linear range concentrations ranged from 0 to 843 mg/dL.
- CSF: Mean observed linear range concentrations ranged from 0 to 887 mg/dL.
Measuring Interval
- Serum/Plasma application: 5 mg/dL to 800 mg/dL.
- Urine/Cerebrospinal (CSF) application: 1 mg/dL to 800 mg/dL.
- The measuring interval is defined as the range of values which meets the limits of acceptable performance for linearity, imprecision, and bias.
Interference
- Alinity c Glucose Reagent Kit - Serum Samples: Evaluated based on CLSI document EP07-A2. Considered significant interference if bias >6% or >1 mg/dL. The assay was not susceptible to interference from Unconjugated Bilirubin (≤ 30 mg/dL), Conjugated Bilirubin (≤ 60 mg/dL), Hemoglobin (≤ 2,000 mg/dL), Triglycerides (≤ 2,000 mg/dL), Ascorbic Acid (≤ 6 mg/dL), Acetaminophen (≤ 20 mg/dL), Ibuprofen (≤ 50 mg/dL), Acetylcysteine (≤ 167 mg/dL), Acetylsalicylic Acid (≤ 66 mg/dL), and Sodium Salicylate (≤ 70 mg/dL).
- Alinity c Glucose Reagent Kit - Urine Samples: Evaluated based on CLSI document EP07-A2. Considered significant interference if bias >10% or >1 mg/dL. The assay was not susceptible to interference from Protein (≤ 50 mg/dL), Ascorbate (≤ 200 mg/dL), 8.5 N Acetic Acid (6% or >1 mg/dL significant interference.
- Urine: >10% or >1 mg/dL significant interference.
- Method Comparison (Passing-Bablok Regression):
- Correlation Coefficient for Serum, Urine, and CSF: 1.00.
- Slopes for Serum, Urine, and CSF: 1.00, 0.99, 1.00 respectively.
- Auto Dilution: Mean % difference of -0.4% (range: -5.1% to 2.6%), acceptance within ±10%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2017
ABBOTT LABORATORIES NOAH LERMER, PH.D. REGULATORY AFFAIRS DIRECTOR DEPT. 9AA, BLDG CP01-3, 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064
Re: K170316
Trade/Device Name: Alinity c Glucose Reagent Kit Alinity c System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JJE Dated: September 06, 2017 Received: September 07, 2017
Dear Dr. Noah Lermer:
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 (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
1
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,
Stayce Beck -A
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) K170316
Device Name Alinity c Glucose Reagent Kit
Indications for Use (Describe)
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K170316
Device Name Alinity c System
Indications for Use (Describe)
The Alinity c System is a fully autom/continuous access, clinical chemistry analyzer intended for the in viro determination of analytes in body fluids.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K170613 510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. Applicant Name
Abbott Laboratories Dept. 09AA, Bldg CP1 100 Abbott Park Road Abbott Park, IL 60064
Primary contact person for all communications:
Noah Lermer, PhD ADD, Director, Regulatory Affairs Phone: (224)-668-7613 Fax: (224) 667-4836 Email: Noah.Lermer@abbott.com
Secondary contact person for all communications:
Amy Ghering, PhD ADD, Associate Director, Regulatory Affairs Phone: (224) 668-6934 Fax: (224) 667-4836 Email: Amy.Ghering@abbott.com
Date Summary Prepared: January 31, 2017.
Date Summary Revised: October 19, 2017
5
II. Device Name
Alinity c Glucose Reagent Kit Alinity c System
Alinity c Glucose Reagent Kit
Device Classification: Class II Classification Name: Hexokinase, glucose Governing Regulation: CFR 862.1345 Product Code: CFR
Alinity c System
Device Classification: Class I Classification Name: Discrete photometric chemistry analyzer for clinical use Governing Regulation: CFR 862.2160 Product Code: JJE
III. Predicate Device
Reagent Glucose (K060383)
Instrument
AEROSET/ARCHITECT c System family members (K980367)
6
IV. Description of Device
A. Alinity c Glucose Reagent Kit
Kit Contents
Volumes (mL) listed in the table below indicate the volume per cartridge.
| Ref | 07P5520 | 07P5530 |
|---|---|---|
| Tests per cartridge | 400 | 1100 |
| Number of cartridges per kit | 10 | 10 |
| Tests per kit | 4000 | 11,000 |
| Reagent 1 (R1) | 26.5 mL | 66.4 mL |
| Reagent | Reactive Ingredients | Concentration |
|---|---|---|
| Reagent 1 | ATP •2Na | 9.0 mg/mL |
| NAD | 5.0 mg/mL | |
| G-6-PDH | 3000 U/L | |
| Hexokinase | 15,000 U/L |
7
B. Alinity c Multiconstituent Calibrator Kit
The Alinity c Multiconstituent Calibrator contains:
| Number of Bottles × Volume | ||
|---|---|---|
| Component | 08P6001 | |
| Cal 1 | 3 × 2.9 mL | |
| Cal 2 | 3 × 2.9 mL |
The Alinity c Multiconstituent calibrators are prepared from a human-based matrix containing multiple analytes, including glucose. Sodium azide is present as a preservative.
The Alinity c Multiconstituent calibrators are prepared and standardized, for glucose, as described in the table below:
| Analyte | Reference Material | Reference Method |
|---|---|---|
| Glucose | NIST SRM 965 | ID-GC/MS |
NIST- National Institute of Standards and Technology SRM- Standard Reference Materials
ID-GC/MS- Isotope Dilution- Gas Chromatography Mass Spectrophotometry
C. Alinity c System
The Alinity c System is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c System uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration.
8
D. Principles of the Procedure
Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
Methodology: Enzymatic (Hexokinase/ G-6-PDH)
V. Intended Use of the Device
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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.
The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.
VI. Comparison of Technological Characteristics
The Alinity c Glucose Reagent Kit is used for the quantitative analysis of glucose in human serum/plasma, urine or cerebrospinal fluid on the Alinity c analyzer.
The similarities and differences of the candidate assay (Alinity c Glucose Reagent Kit, LN 07P55) to the predicate assay (Glucose assay, LN 3L82) are presented in Table 1 starting on page 7 and Table 2 starting on page 8, respectively.
The similarities and differences between the Alinity c System and the AEROSET/ARCHITECT c System (K980367) are presented in Table 3 on page 9 and Table 4 on page 10, respectively.
9
Table 1: Reagent Similarities
| Characteristics | Candidate Assay
Alinity c Glucose Reagent Kit
(LN 07P55) | Predicate Assay (K060383)
Glucose
(LN 3L82) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Technical Characteristics | | |
| Reagent Formulation | R1: Active ingredients: ATP• 2Na (9.0 mg/mL), NAD
(5.0 mg/mL), G-6-PDH (3000 U/L), Hexokinase (15 000 U/L),
Preservative: sodium azide (0.05%). | Same |
| Analyte Measured | Glucose | Same |
| Intended Use | The Alinity c Glucose assay is used for the quantitation of
glucose in human serum, plasma, urine, or cerebrospinal fluid
(CSF). | Same |
| Indications for Use | 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. | Same |
| Assay Principle | Glucose is phosphorylated by hexokinase (HK) in the presence
of adenosine triphosphate (ATP) and magnesium ions to
produce glucose-6-phosphate (G-6-P) and adenosine
diphosphate (ADP). Glucose-6-phosphate dehydrogenase
(G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate
with the concurrent reduction of nicotinamide adenine
dinucleotide (NAD) to nicotinamide adenine dinucleotide
reduced (NADH). One micromole of NADH is produced for
each micromole of glucose consumed. The NADH produced
absorbs light at 340 nm and can be detected
spectrophotometrically as an increased absorbance. | Same |
| Detection of Analyte | End-point colorimetric. | Same |
| Specimen Type | Human serum, plasma, urine, or CSF. | Same |
| | Candidate Assay
Alinity c Glucose Reagent Kit
(LN 07P55) | Predicate Assay (K060383)
Glucose
(LN 3L82) |
| Characteristics | | |
| Performance Characteristics | | |
| Assay Range | Serum/Plasma
5 to 800 mg/dL (0.28 to 44.40 mmol/L).
Urine/ CSF
1 to 800 mg/dL (0.06 to 44.40 mmol/L). | Same |
| Measuring Interval | Serum/ Plasma
The measuring interval of the serum/plasma application is 5 to
800 mg/dL (0.28 to 44.40 mmol/L).
Urine/ CSF
The measuring interval of the urine/CSF application is 1 to
800 mg/dL (0.06 to 44.40 mmol/L). | Same |
| Tube Types | Serum
Serum tubes (with or without gel barrier).
Plasma
Collection tubes
Acceptable anticoagulants are: Lithium heparin (with or without
gel barrier), Sodium heparin, Sodium fluoride/ potassium
oxalate, EDTA. | Same |
| Use of Calibrators | Yes | Same |
| Use of Controls | Yes; Commercially available controls | Same |
10
r
11
| Characteristics | Alinity c Glucose Reagent Kit
(LN 07P55) | Predicate Assay (K060383)
Glucose
(LN 3L82) |
|-------------------|---------------------------------------------|-----------------------------------------------------------|
| Reagent Container | Polypropylene | High Density Polyethylene |
| | Black color | White colorant |
| Closure Material | High Density Polyethylene | F217 cap liner |
| | Black color | Polyethylene Foam between Low-Density Polyethylene liners |
| | | Green color |
Table 2: Reagent Differences
12
| Characteristics | Candidate Device
Alinity c System | Predicate Device
AEROSET/ARCHITECT c System (K980367) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Intended Use/Indication for Use | The Alinity c System is a fully automated, random/continuous
access, clinical chemistry analyzer intended for the in vitro
determination of analytes in body fluids. | Same |
| Detection Technology | Potentiometric/Photometric | Same |
| Sample Handling | Robotic sample handler (RSH). Transport system that has random and continuous access to samples. Autoretest Capability
Priority and batch sample loading | Same |
| Reagent Handling | The on-board storage area cooler provides evaporation control.
Continuous Reagent Access. | Same |
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Table 4: Instrument Differences
| Characteristics | Alinity c System | AEROSET / ARCHITECT c System |
|---|---|---|
| Calibrator / Control Automation | Direct aspiration from the calibrator/control bottles | No. |
| Reagent Access | Continuous Reagent Access. | Scheduled Reagent Access. |
| Bulk Solutions Replenishment | Continuous Bulk Solution Access. | Scheduled Bulk Solution Access. |
| Priority Sample Loading | All carrier positions are available to have a priority sample loading | |
| designation. | Select positions available for priority loading. |
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VII. Summary of Nonclinical Performance
Within-Laboratory Precision (20-Day)
Alinity Glucose Reagent Kit- Serum Samples
Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2.
A summary of results is presented below:
| Sample | Control
Lot | n | Mean
(mg/dL) | Within-Run
(Repeatability) | | Within-Laboratorya | |
|-----------------|----------------|-----|-----------------|-------------------------------|-----|--------------------|------------------|
| | | | | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) |
| Control Level 1 | 1 | 264 | 55 | 0.6 | 1.1 | 0.7
(0.5-0.8) | 1.2
(1.0-1.4) |
| | 2 | 264 | 55 | 0.5 | 0.9 | 0.6
(0.5-0.7) | 1.1
(0.9-1.2) |
| Control Level 2 | 1 | 264 | 128 | 1.1 | 0.8 | 1.3
(1.1-1.4) | 1.0
(0.9-1.1) |
| | 2 | 263 | 128 | 0.9 | 0.7 | 1.3
(1.1-1.4) | 1.0
(0.9-1.1) |
| Control Level 3 | 1 | 264 | 315 | 2.2 | 0.7 | 2.8
(2.5-3.1) | 0.9
(0.8-1.0) |
| | 2 | 260 | 311 | 2.1 | 0.7 | 2.5
(2.1-2.9) | 0.8
(0.7-0.9) |
| Panel A | N/A | 527 | 7 | 0.1 | 1.9 | 0.1
(0.0-0.2) | 1.9
(0.0-2.8) |
| Panel B | N/A | 528 | 106 | 0.8 | 0.8 | 1.0
(0.8-1.2) | 0.9
(0.7-1.2) |
| Panel C | N/A | 523 | 728 | 5.6 | 0.8 | 5.9
(4.4-7.6) | 0.8
(0.6-1.1) |
4 Includes within-run, between-run, and between-day variability.
b Minimum and maximum SD or %CV for each reagent lot and instrument combination.
The precision of the Alinity c Glucose assay was considered acceptable if the within-laboratory imprecision (within-run, between-run, and between-day) was ≤ 5 %CV for serum samples targeted between 80 to 281 mg/dL.
The Alinity c Glucose assay demonstrated acceptable precision.
15
Alinity Glucose Reagent Kit- Urine Samples
Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2.
A summary of results is presented below:
| | | | | Within-Run
(Repeatability) | | Within-Laboratorya | |
|-----------------|----------------|-----|-----------------|-------------------------------|-----|--------------------|------------------|
| Sample | Control
Lot | n | Mean
(mg/dL) | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) |
| Control Level 1 | 1 | 264 | 38 | 0.4 | 1.0 | 0.5
(0.5-0.5) | 1.3
(1.3-1.3) |
| | 2 | 263 | 38 | 0.3 | 0.9 | 0.6
(0.5-0.6) | 1.4
(1.4-1.5) |
| Control Level 2 | 1 | 260 | 359 | 2.9 | 0.8 | 3.4
(2.9-4.0) | 1.0
(0.8-1.1) |
| | 2 | 264 | 353 | 2.4 | 0.7 | 3.0
(2.5-3.3) | 0.8
(0.7-0.9) |
| Panel A | N/A | 527 | 3 | 0.1 | 3.8 | 0.1
(0.0-0.2) | 3.8
(0.0-6.4) |
| Panel B | N/A | 526 | 60 | 1.0 | 1.6 | 1.2
(1.1-1.5) | 2.1
(1.8-2.5) |
| Panel C | N/A | 528 | 110 | 2.4 | 2.2 | 3.1
(2.5-4.2) | 2.8
(2.3-3.8) |
| Panel D | N/A | 525 | 712 | 6.2 | 0.9 | 8.1
(7.4-8.7) | 1.1
(1.0-1.2) |
4 Includes within-run, between-run, and between-day variability.
b Minimum and maximum SD or %CV for each reagent lot and instrument combination.
The precision of the Alinity c Glucose assay was considered acceptable if the within-laboratory imprecision (within-run, between-run, and between-day) was ≤ 6 %CV for urine samples targeted between 30 to 306 mg/dL.
The Alinity c Glucose assay demonstrated acceptable precision.
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Alinity Glucose Reagent Kit- Cerebrospinal Fluid (CSF) Samples
Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2.
A summary of results is presented below:
| | | | | Within-Run
(Repeatability) | | Within-Laboratorya | |
|-----------------|----------------|-----|-----------------|-------------------------------|-----|--------------------|------------------|
| Sample | Control
Lot | n | Mean
(mg/dL) | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) |
| Control Level 1 | 1 | 264 | 60 | 0.5 | 0.9 | 0.6
(0.6-0.7) | 1.1
(1.0-1.1) |
| | 2 | 264 | 61 | 0.5 | 0.7 | 0.6
(0.6-0.6) | 1.0
(1.0-1.0) |
| Control Level 2 | 1 | 264 | 30 | 0.3 | 0.9 | 0.3
(0.3-0.4) | 1.1
(0.9-1.2) |
| | 2 | 263 | 31 | 0.4 | 1.1 | 0.4
(0.2-0.5) | 1.3
(0.8-1.6) |
| Panel A | N/A | 527 | 3 | 0.1 | 4.8 | 0.1
(0.1-0.2) | 4.8
(2.9-7.5) |
| Panel B | N/A | 528 | 57 | 0.4 | 0.8 | 0.5
(0.4-0.6) | 0.9
(0.8-1.0) |
| Panel C | N/A | 527 | 107 | 0.7 | 0.7 | 0.8
(0.7-1.0) | 0.8
(0.6-1.0) |
| Panel D | N/A | 526 | 700 | 3.8 | 0.5 | 4.8
(4.3-5.3) | 0.7
(0.6-0.8) |
4 Includes within-run, between-run, and between-day variability.
b Minimum and maximum SD or %CV for each reagent lot and instrument combination.
The precision of the Alinity c Glucose assay was considered acceptable if the within-laboratory imprecision (within-run, between-run, and between-day) was ≤ 5 %CV for CSF samples targeted between 29 to 60 mg/dL.
The Alinity c Glucose assay demonstrated acceptable precision.
17
Accuracy
Alinity c Glucose Reagent Kit-Serum
A minimum of 1 level of a NIST standard (SRM 965b, Glucose in Human Serum) at or near the medical decision point of the Alinity c Glucose serum assay was tested.
The results are summarized in the table below.
| Sample Set | Target
(mg/dL) | N | Mean
(mg/dL) | SD | %CV | Bias | %Bias | Total
Error
(mg/dL) | % Total
Error |
|--------------|-------------------|----|-----------------|-----|-----|------|-------|---------------------------|------------------|
| NIST level 1 | 33.08 | 22 | 33 | 0.4 | 1.1 | 0 | 0.2 | 0.8 | 2.3 |
| NIST level 2 | 75.56 | 22 | 76 | 0.5 | 0.7 | 1 | 1.2 | 1.9 | 2.5 |
| NIST level 3 | 118.5 | 22 | 120 | 0.6 | 0.5 | 1 | 1.1 | 2.5 | 2.1 |
| NIST level 4 | 294.5 | 22 | 306 | 1.4 | 0.5 | 11 | 3.8 | 14.0 | 4.7 |
Limit of Blank, Limit of Detection, and Limit of Quantitation
Alinity c Glucose Reagent Kit-Serum/Plasma, Urine/CSF Samples
The LoB, LoD, and LoQ study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
The results are summarized in the table below:
| | Serum/Plasma
(mg/dL) | Urine/CSF
(mg/dL) |
|------|-------------------------|----------------------|
| LoBa | 0.33 | 0.23 |
| LoDb | 0.55 | 0.40 |
| LoQc | 2.25 | 0.86 |
a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.
b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.
C The LoQ was determined from n ≥ 60 replicates of low-analyte level samples and is defined as the lowest concentration at which a maximum allowable precision of 20 %CV was met.
18
Linearity
Alinity c Glucose Reagent Kit- Serum/Plasma, Urine/CSF Samples
Linearity was determined based on guidance from Clinical and Laboratory Standards Institute (CLSI) document EP06-A.
Serum/Plasma: The mean observed linear range concentrations ranged from 0 to 828 mg/dL for the sample set.
Urine: The mean observed linear range concentrations ranged from 0 to 843 mg/dL for the sample set.
CSF: The mean observed linear range concentrations ranged from 0 to 887 mg/dL for the sample set.
Measuring Interval
The measuring interval of the Alinity c Glucose Serum/ Plasma application is 5 mg/dL to 800 mg/dL. The measuring interval of the Alinity c Glucose Urine/Cerebrospinal (CSF) application is 1 mg/dL to 800 mg/dL.
The measuring interval is defined as the range of values which meets the limits of acceptable performance for linearity, imprecision, and bias. The inputs to the measuring interval include imprecision, limit of quantification and linearity.
19
Interference
Alinity c Glucose Reagent Kit– Serum Samples
Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2.
For serum/plasma, a bias of >6% or >1 mg/dL was considered significant interference.
The Alinity c Glucose assay using the serum application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below:
| Interferent | Interferent Level |
|---|---|
| Unconjugated Bilirubin | $\u2264$ 30 mg/dL |
| Conjugated Bilirubin | $\u2264$ 60 mg/dL |
| Hemoglobin | $\u2264$ 2,000 mg/dL |
| Triglycerides | $\u2264$ 2,000 mg/dL |
| Ascorbic Acid | $\u2264$ 6 mg/dL |
| Acetaminophen | $\u2264$ 20 mg/dL |
| Ibuprofen | $\u2264$ 50 mg/dL |
| Acetylcysteine | $\u2264$ 167 mg/dL |
| Acetylsalicylic Acid | $\u2264$ 66 mg/dL |
| Sodium Salicylate | $\u2264$ 70 mg/dL |
20
Alinity c Glucose Reagent Kit– Urine Samples
Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2.
For urine, a bias of >10% or >1 mg/dL was considered significant interference.
The Alinity c Glucose assay using the urine application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below:
| Interferent | Interferent Level |
|---|---|
| Protein | ≤ 50 mg/dL |
| Ascorbate | ≤ 200 mg/dL |
| 8.5 N Acetic Acid |