(356 days)
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No
The device description and performance studies focus on a standard enzymatic chemical reaction and photometric measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in vitro diagnostic reagent used to measure glucose concentration, which aids in the diagnosis and treatment of carbohydrate metabolism disorders. It does not directly provide therapy or treatment to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma." This indicates the device is used for diagnostic purposes.
No
The device described is a reagent (GLUH) used in conjunction with a hardware system (UniCel® DxC 600/800 SYNCHRON System(s)) for the quantitative determination of glucose. It is a chemical component of a larger in vitro diagnostic system, not a standalone software 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 device is "intended for the quantitative determination of glucose concentration in human serum. plasma, urine or cerebrospinal fluid (CSF)." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health.
- Diagnosis and Treatment: The intended use also mentions that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma." This further confirms its role in clinical decision-making based on in vitro analysis.
- Device Description: The "Device Description" details the chemical reaction and the process by which the glucose concentration is measured in the sample. This describes the in vitro analytical method.
- Performance Studies: The "Summary of Performance Studies" describes various tests performed on the reagent and system using biological samples (serum, plasma, urine, CSF) to evaluate its performance characteristics. This is typical for the validation of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K883181; Beckman Coulter GLU assay) indicates that this device is being compared to a previously cleared IVD, which is a common regulatory pathway for new IVDs.
All these points strongly indicate that the UniCel DxC SYNCHRON Systems Glucose reagent (GLUH), when used as described, is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
CFR
Device Description
GLUH reagent is used to measure the glucose concentration by a timed endpoint method. In the reaction, hexokinase (HK) catalyses the transfer of a phosphate group from adenosine triphosphate (ATP) to glucose to form adenosine diphosphate (ADP) and glucose-6phosphate. The glucose-6-phosphate is then oxidized to 6-phosphogluconate with the concomitant reduction of ß-nicotinamide adenine dinucleotide (NAD) to reduced ßnicotinamide adenine dinucleotide (NADH) by the catalytic action of glucose-6-phosphate dehydrogenase (G6PDH).
The UniCel® DxC 600/800 SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 100 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of glucose in the sample and is used by the System to calculate and express glucose concentration.
The GLUH uses the following chemical reaction scheme:
Glucose + ATP -> HK glucose-6-phosphate + ADP
Glucose-6-phosphate + NAD+ -> G6PDH 6-phosphogluconate + NADH + H+
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of studies were performed to evaluate the following non-clinical performance characteristics for the GLUH Reagent: method comparison, anticoagulant, precision, sensitivity, linearity, interferences, sample stability, sample dilution, reagent stability, reference range, and calibration stability experiments.
Method Comparison
Methods comparison experiments were designed using CLSI Procedure EP9-A2: "Method Comparison and Bias Estimation Using Patients Samples". The patient correlation studies were conducted using the SYNCHRON Glucose (GLU) (Method X) and the candidate UniCel DxC SYNCHRON Systems Glucose (GLUH) (Method Y) for serum and CSF matrices. Patient correlation studies were conducted using the SYNCHRON modular Glucose (GLUCm) (Method X) and the candidate Beckman Coulter UniCel DxC SYNCHRON Systems Glucose (GLUH) (Method Y) for urine samples. A minimum of 100 samples were tested for each matrix.
UniCel DxC 600
- Serum: N=120, Slope=0.982, Intercept=-1.02, R=1.000
- CSF: N=100, Slope=0.978, Intercept=1.25, R=1.000
- Urine: N=117, Slope=0.989, Intercept=2.08, R=1.000
UniCel DxC 800
- Serum: N=120, Slope=0.999, Intercept=-1.60, R=1.000
- CSF: N=100, Slope=1.002, Intercept=-0.61, R=1.000
- Urine: N=117, Slope=0.973, Intercept=2.86, R=1.000
Anticoagulant Studies
Anticoagulant experiments were designed using CLSI Procedure EP14-A2: "Evaluation of Matrix Effects: Approved Guidelines - Second Edition". For each anticoagulant tested, paired plasma and serum samples from healthy volunteers were drawn. Over 50 patient specimens with glucose concentrations spanning the analytical range were obtained and tested internally.
DxC600
- Sodium Heparin: N=79, Deming Regression Analysis: y= 0.983 + 0.849, R= 0.999
- Lithium Heparin: N=79, Deming Regression Analysis: y= 0.994 + 0.393, R= 0.999
- Sodium Fluoride/Potassium Oxalate: N=79, Deming Regression Analysis: y= 0.995 + 1.007, R= 0.999
DxC800
- Sodium Heparin: N=58, Deming Regression Analysis: y= 0.998 - 0.172, R= 0.999
- Lithium Heparin: N=58, Deming Regression Analysis: y= 1.02 - 2.476, R= 1.000
- Sodium Fluoride/Potassium Oxalate: N=58, Deming Regression Analysis: y= 1.012 - 0.302, R= 0.999
Precision
Precision studies were conducted in accordance with CLSI EP5-A2. Multiple levels of samples were tested 4 times a day for 20 days. The user of a UniCel DxC 600/800 SYNCHRON System(s) should expect the instrument to produce imprecision values less than or equal to the claimed maximum performance limits (S.D. or % CV). The claimed within run SD is 2.0 mo/dL, and the claimed total SD is 3.0 mg/dL. The claimed within run %CV is 2.0, and the claimed total %CV is 3.0. The changeover value is 100.0 mg/dL.
Within Run DxC 600 (N=80 data points for each sample type)
- Serum Control 1: Mean=43 mg/dL, SD=0.7, %CV=1.6
- Serum Control 2: Mean=219 mg/dL, SD=2.3, %CV=1.0
- Serum Control 3: Mean=390 mg/dL, SD=5.7, %CV=1.5
- Serum Pool 1: Mean=9 mg/dL, SD=0.3, %CV=3.6
- Serum Pool 2: Mean=101 mg/dL, SD=1.1, %CV=1.1
- Serum Pool 3: Mean=660 mg/dL, SD=6.4, %CV=1.0
- Urine Pool 1: Mean=10 mg/dL, SD=0.3, %CV=3.2
- Urine Pool 2: Mean=95 mg/dL, SD=0.9, %CV=1.0
- Urine Pool 3: Mean=670 mg/dL, SD=5.2, %CV=0.8
- CSF Pool 1: Mean=11 mg/dL, SD=0.3, %CV=3.0
- CSF Pool 2: Mean=100 mg/dL, SD=1.3, %CV=1.2
- CSF Pool 3: Mean=677 mg/dL, SD=7.0, %CV=1.0
Total DxC 600 (N=80 data points for each sample type)
- Serum Control 1: Mean=43 mg/dL, SD=0.8, %CV=1.9
- Serum Control 2: Mean=219 mg/dL, SD=2.6, %CV=1.2
- Serum Control 3: Mean=390 mg/dL, SD= undisclosed, %CV=1.7
- Serum Pool 1: Mean=9 mg/dL, SD=0.6, %CV= unspecified
- Serum Pool 2: Mean=101 mg/dL, SD=1.6, %CV=1.6
- Serum Pool 3: Mean= unidentified mg/dL, SD=8.4, %CV=1.3
- Urine Pool 1: Mean=10 mg/dL, SD=0.6, %CV=5.7
- Urine Pool 2: Mean= unspecified mg/dL, SD=1.4, %CV=1.5
- Urine Pool 3: Mean=670 mg/dL, SD=6.1, %CV=0.9
- CSF Pool 1: Mean=11 mg/dL, SD=0.6, %CV=5.3
- CSF Pool 2: Mean=109 mg/dL, SD=1.6, %CV=1.5
- CSF Pool 3: Mean=677 mg/dL, SD=8.6, %CV=1.3
Within Run DxC 800 (N=80 data points for each sample type)
- Serum Control 1: Mean=43 mg/dL, SD=0.5, %CV=1.2
- Serum Control 2: Mean=219 mg/dL, SD=2.7, %CV=1.2
- Serum Control 3: Mean=389 mg/dL, SD=6.3, %CV=1.6
- Serum Pool 1: Mean=9 mg/dL, SD=0.3, %CV=3.2
- Serum Pool 2: Mean=101 mg/dL, SD=1.1, %CV=1.1
- Serum Pool 3: Mean=662 mg/dL, SD=7.5, %CV=1.1
- Urine Pool 1: Mean=10 mg/dL, SD=0.3, %CV=3.0
- Urine Pool 2: Mean=94 mg/dL, SD=1.2, %CV=1.2
- Urine Pool 3: Mean=668 mg/dL, SD=7.9, %CV=1.2
- CSF Pool 1: Mean=11 mg/dL, SD=0.3, %CV=2.3
- CSF Pool 2: Mean=108 mg/dL, SD=1.1, %CV=1.0
- CSF Pool 3: Mean=680 mg/dL, SD=6.7, %CV=1.0
Total DxC 800 (N=80 data points for each sample type)
- Serum Control 1: Mean=43 mg/dL, SD=0.7, %CV=1.7
- Serum Control 2: Mean=219 mg/dL, SD=3.5, %CV=1.6
- Serum Control 3: Mean=389 mg/dL, SD=7.2, %CV=1.9
- Serum Pool 1: Mean=9 mg/dL, SD=0.3, %CV=3.6
- Serum Pool 2: Mean=101 mg/dL, SD=1.2, %CV=1.2
- Serum Pool 3: Mean=662 mg/dL, SD=9.4, %CV=1.4
- Urine Pool 1: Mean=10 mg/dL, SD=0.4, %CV=3.7
- Urine Pool 2: Mean=94 mg/dL, SD=1.3, %CV=1.3
- Urine Pool 3: Mean=668 mg/dL, SD=8.1, %CV=1.2
- CSF Pool 1: Mean=11 mg/dL, SD=0.4, %CV=3.6
- CSF Pool 2: Mean=108 mg/dL, SD=1.7, %CV=1.6
- CSF Pool 3: Mean=680 mg/dL, SD=8.1, %CV=1.2
Analytical Sensitivity (Limits of detection)
Limit of blank (LoB), limit of detection (LoD), and Limit of Quantitation (LoQ) data analyses were performed in accordance with the CLSI EP17-A2 guideline. Multiple urine, CSF and serum pools were run over multiple days to establish and verify the analytical sensitivity claims. The claimed LoB, LoD and LoQ values are ≤5mg/dL.
- Serum: LoB = 0.19 mg/dL (0.011 mmol/L), LoD = 1.74 mg/dL (0.097 mmol/L), LoQ = 3.78 mg/dL (0.210 mmol/L)
- CSF: LoB = 0.17 mg/dL (0.009 mmol/L), LoD = 1.68 mg/dL (0.093 mmol/L), LoQ = 3.67 mg/dL (0.204 mmol/L)
- Urine: LoB = 0.19 mg/dL (0.011 mmol/L), LoD = 1.78 mg/dL (0.099 mmol/L), LoQ = 3.69 mg/dL (0.205 mmol/L)
Linearity
The study followed CLSI EP-6A. The data substantiates GLUH test is linear between 5 and 700 mg/dL.
DxC 600:
- Serum: y= 1.01016x + 1.0881
- CSF: y = 1.0075x + 1.5157
- Urine: y= 1.0011x + 0.4464
DxC 800:
- Serum: y=1.0035x + 2.1977
- CSF: v = 1.0081x + 1.5778
- Urine: y= 0.9991x -+ 1.068
Interferences
Interference studies were designed from CLSI Guideline EP7-A: "Interference Testing in Clinical Chemistry - Approved Guideline" and used to assess common or known substances which could interfere with the UniCel DxC SYNCHRON Systems GLUH assay. Results are provided for Hemoglobin, Bilirubin, Lipemia, Ascorbic Acid, Urea, Uric Acid, EDTA, and Creatinine at low, mid, and high glucose levels. A properly operating UniCel DxC 600/800 SYNCHRON System(s) should exhibit interference values less than or equal to: ± 6 mg/dL or 10%, with a crossover value of 60 mg/dL. All tested substances demonstrated recovery within acceptable limits.
Sample dilution
Saline was chosen as the appropriate diluent. There was no issue or effect observed when verifying saline as an appropriate sample diluent.
Reagent stability
The testing establishes that the GLUH reagent is stable on board for 30 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized circular graphic to the left of the company name. The company name is written in a bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Summary of Safety & Effectiveness UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
1.0 Submitted By:
Yvette Lloyd Consultant Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E1.SE.01 Brea, CA 92821 Phone: (714) 307-3469 FAX: (714) 961-4234 email: yrlloyd@beckman.com
2.0 Date Submitted:
April 4, 2014
3.0 Device Name(s):
3.1 Proprietary Names UniCel DxC SYNCHRON Systems Glucose reagent (GLUH)
3.2 Classification Name
Glucose test system (21 CFR 862.1345, Product Code CFR)
4.0 Predicate Devices:
| CANDIDATE | PREDICATE (K#) | Classification
— Regulation | Classification
Panel | Product
Code |
|-------------------------------------------|----------------------------------------|--------------------------------|----------------------------|-----------------|
| UniCel DxC
SYNCHRON
Systems
GLUH | Beckman Coulter GLU
assay (K883181) | Class II
862.1345 | 75 (Clinical
Chemistry) | CFR |
1
5.0 Description:
Reagent:
GLUH reagent is used to measure the glucose concentration by a timed endpoint method. In the reaction, hexokinase (HK) catalyses the transfer of a phosphate group from adenosine triphosphate (ATP) to glucose to form adenosine diphosphate (ADP) and glucose-6phosphate. The glucose-6-phosphate is then oxidized to 6-phosphogluconate with the concomitant reduction of ß-nicotinamide adenine dinucleotide (NAD) to reduced ßnicotinamide adenine dinucleotide (NADH) by the catalytic action of glucose-6-phosphate dehydrogenase (G6PDH).
The UniCel® DxC 600/800 SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 100 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of glucose in the sample and is used by the System to calculate and express glucose concentration.
The GLUH uses the following chemical reaction scheme:
| Glucose + ATP | HK glucose-6-phosphate + ADP |
|---|---|
| Glucose-6-phosphate + NAD + | G6PDH 6-phosphogluconate + NADH + H+ |
6.0 Intended Use:
INTENDED USE
UniCel DxC SYNCHRON Systems Glucose reagent (GLUH), when used in conjunction with UniCel® DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum. plasma, urine or cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
7.0 Comparison to Predicate(s):
The following tables show the similarities and differences between the modified device and the predicate device identified in Section 4.0 of this summary.
| Characteristics | UniCel DxC
SYNCHRON
Systems GLUH
Reagent | SYNCHRON Systems LX and UniCel DxC GLU
reagent (K883181) | List of design inputs that are different between the two reagent devices | | |
|---------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Same | Intended for the quantitative determination of
glucose using serum, plasma, urine, or CSF as a
sample type. | UniCel DxC SYCNHRON Systems
GLUH Reagent | SYNCHRON Systems LX and UniCel
DxC GLU'reagent (K883181) | |
| Clinical
indications | Same | Glucose measurements are used in the diagnosis
and treatment of carbohydrate metabolism
disorders including diabetes mellitus, neonatal
hypoglycemia, idiopathic hypoglycemia, and
pancreatic islet cell carcinoma. | Calibrator used | SYNCHRON Systems AQUA CAL 1
SYNCHRON Systems AQUA CAL 3
(K071277) | SYNCHRON MultiCal (K110251) |
| Methodology | Same | Timed endpoint method | Calibrator Stability
(opened) | 30 days | 20 days |
| Reaction
principle | Same | $ Glucose + ATP → glucose-6-phosphate + ADP Glucose-6-phosphate + NAD+ → 6-phosphogluconate + NADH + H+ $ | Interferences | | |
| Fundamental
Technology | Same | Spectrophotometric detection | Bilirubin | 24 mg/dL | 24 mg/dL |
| System use | Same (NOTE:
GLUH is only
applied to the DxC
600/800 systems) | For use on clinical chemistry analyzers | Hemoglobin | 500 mg/dL | 400 mg/dL |
| Analytic Range | Same | 5-700 mg/dL | Lipemia | Low pool: Serum index = >6 (3+) (Human
lipemia)
Mid/High Pool: Serum index = 10(4+)
(Human Lipemia) | 400 mg/dL (4+) (Intralipid) |
| Reagent | Same | SYNCHRON Systems Glucose reagent,
REAGENT CONSTITUENTS:
Adenosine Triphosphate, 3.8 mmol/L; NAD+, 2.7
mmol/L; Hexokinase, 2.0 KIU/L; Glucose-6-
phosphate dehydrogenase, 3.0 KIU/L;
Also non-reactive chemicals necessary for optimal
system performance. | Ascorbic Acid | 6.0 mg/dL | 3.0 mg/dL |
| Reference
Intervals | Same | Sample type range
Serum/plasma 74-106 mg/dL
Urine 1-15 mg/dL
Urine (timed) 48 hours at ≤ -15 to -20°C
Serum/plasma
- 1 freeze/thaw cycle (when stored at -15 to -
20°C) | Uric Acid | 40 mg/dL | 20 mg/dL |
| Linearity | Same | Analytical range = 5-700mg/dL, with sample dilution
using saline for samples exceeding the high end of
the linear range. | EDTA | 16 mg/dL | 8 mg/dL |
| Sample type | Same | Serum/plasma, CSF, urine | Creatinine | 40 mg/dL | 30 mg/dL |
| Within run
Precision Claims | Same | SD - 2.0 mg/dL
CV - 2.0% | Anticoagulant | Lithium Heparin, Sodium Heparin,
Potassium Oxalate/Sodium Fluoride | Ammonium Heparin, Lithium Heparin,
Sodium Heparin, Potassium
Oxalate/Sodium Fluoride |
| Total Precision
Claims | Same | SD - 3.0 mg/dL
CV - 3.0% | Sensitivity | ≤5 mg/dL | 10 | 189.1 | 184.6 | 97.6 |
| Ascorbic Acid | NA | 6.0 mg/dL | 167.7 | 166.4 | 99.2 |
| Urea | NA | 500 mg/dL | 207.1 | 208.9 | 100.9 |
| Uric Acid | NA | 40 mg/dL | 166.8 | 168.4 | 101 |
| EDTA | NA | 16 mg/dL | 167 | 168.1 | 100.7 |
| Creatinine | NA | 40 mg/dL | 173.8 | 173.4 | 99.8 |
| High Level Glucose Pool | | | | | |
| Substance | Source | Maximum Level Tested | Target (mg/dL) | Recovered (mg/dL) | % recovery* |
| Hemoglobin | RBC hemolysate | 500 mg/dL | 410.7 | 406.1 | 98.9 |
| Bilirubin | Bovine | 24 mg/dL | 407.2 | 404.8 | 99.4 |
| Lipemia | Human | (4+)
Serum Index =>10 | 461.7 | 453.1 | 98.1 |
| Ascorbic Acid | NA | 6.0 mg/dL | 396.2 | 394.6 | 99.6 |
| Urea | NA | 500 mg/dL | 476 | 477.4 | 100.3 |
| Uric Acid | NA | 40 mg/dL | 397.1 | 405 | 102 |
| EDTA | NA | 16 mg/dL | 402.6 | 404.4 | 100.4 |
| Creatinine | NA | 40 mg/dL | 409.4 | 411.5 | 100.5 |
7
Listings of drugs, diseases and other pre-analytical variables known to affect glucose measurements when analyzing Serum, Urine and CSF are described in References (1,2,3). Visually turbid urine specimens should be centrifuged prior to analysis.
References:
-
Young, D. S., Effects of Drugs on Clinical Laboratory Tests, 5th Edition, AACC Press, Washington, D. C. (2000).
-
Friedman, R. B., Young, D. S.,Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC Press, Washington, D.C. (2001).
.
8
- Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 3rd Edition, AACC Press, Washington, D. C. (2007).
Sample dilution
The objective of this testing is to determine and verify the appropriate sample diluent to use when diluting out of range samples using the UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent. Saline was chosen as the appropriate diluent. There was no issue or effect observed when verifying saline as an appropriate sample diluent.
Reagent stability
The UniCel DxC SYNCHRON Systems Glucose (GLUH) Reagent was tested to verify the onboard stability claim on the UniCel DxC 600/800 SYNCHRON System(s) family of Clinical Chemistry analyzers. The performance assessment involves assaying multiple levels of pooled sera at regular intervals throughout the testing period. The assay was calibrated at 14 day intervals. To be considered acceptable, recovered values must fall within the expected ranges. The testing establishes that the GLUH reagent is stable on board for 30 days.
Reference range
Samples reference intervals are based on published literature references.
| Sample | Literature reference |
|---|---|
| Serum/Plasma | 74-106 mg/dL |
| Urine | 1-15 mg/dL |
| Urine (timed) | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
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