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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the "claimed" limits for some performance characteristics, implying these are the acceptance criteria. For others, the criteria are implied by the study design (e.g., linearity within a range, interference values less than or equal to a certain threshold).

Performance Characteristic	Acceptance Criteria (Claimed/Implied)	Reported Device Performance (GLUH Reagent)
Method Comparison	High correlation (e.g., R-value ~1.000), small bias (slope ~1, intercept ~0) when compared to predicate GLU/GLUCm methods.	UniCel DxC 600: - Serum: Slope 0.982, Intercept -1.02, R 1.000 - CSF: Slope 0.978, Intercept 1.25, R 1.000 - Urine: Slope 0.989, Intercept 2.08, R 1.000UniCel DxC 800: - Serum: Slope 0.999, Intercept -1.60, R 1.000 - CSF: Slope 1.002, Intercept -0.61, R 1.000 - Urine: Slope 0.973, Intercept 2.86, R 1.000 (All reported R-values are 1.000, indicating excellent correlation)
Anticoagulant Effects	Minimal impact on glucose measurements (Deming Regression slope ~1, intercept ~0, R ~1).	DxC600: - Sodium Heparin: y= 0.983 + 0.849, R= 0.999 - Lithium Heparin: y= 0.994 + 0.393, R= 0.999 - Sodium Fluoride/Potassium Oxalate: y= 0.995 + 1.007, R= 0.999DxC800: - Sodium Heparin: y= 0.998 - 0.172, R= 0.999 - Lithium Heparin: y= 1.02 - 2.476, R= 1.000 - Sodium Fluoride/Potassium Oxalate: y= 1.012 - 0.302, R= 0.999 (All R-values are 0.999 or 1.000, indicating strong correlation)
Precision	Within run SD ≤ 2.0 mg/dL, Total SD ≤ 3.0 mg/dL. Within run %CV ≤ 2.0%, Total %CV ≤ 3.0% (at or above changeover value of 100.0 mg/dL).	Within Run (DxC 600 & 800): Max SD observed was 7.5 mg/dL (Serum Pool3 DxC 800) and max %CV was 3.6% (Serum Pool 1 DxC 600 & 800, Urine Pool 1 DxC 600, CSF Pool 1 DxC 600). Most values for samples >=100 mg/dL are well within claimed limits.Total (DxC 600 & 800): Max SD observed was 9.4 mg/dL (Serum Pool3 DxC 800) and max %CV was 5.7% (Urine Pool 1 DxC 600). Most values for samples >=100 mg/dL are well within claimed limits. (Performance across various sample types and concentrations generally meets or comes close to the claimed limits, with some low-concentration samples showing higher %CV as expected.)
Analytical Sensitivity	LoB, LoD, LoQ values ≤ 5 mg/dL.	LoB: Serum 0.19 mg/dL, CSF 0.17 mg/dL, Urine 0.19 mg/dLLoD: Serum 1.74 mg/dL, CSF 1.68 mg/dL, Urine 1.78 mg/dLLoQ: Serum 3.78 mg/dL, CSF 3.67 mg/dL, Urine 3.69 mg/dL (All reported values are well below the 5 mg/dL criterion, indicating high sensitivity.)
Linearity	Linear between 5 and 700 mg/dL.	The data "substantiates GLUH test is linear between 5 and 700 mg/dL." Linear equations for DxC 600 and DxC 800 for Serum, CSF, and Urine demonstrate good linearity (slopes near 1 and small intercepts).
Interferences	Interference values ≤ ± 6 mg/dL or 10% (crossover value 60 mg/dL).	For low-level glucose pools, the mg/dL difference from target and % recovery (relative to 10% tolerance from 60 mg/dL) are generally within acceptable limits. For mid and high-level pools, % recovery values are consistently between 96.5% and 103.5%, mostly within 10% of target. e.g., Hemoglobin (500 mg/dL), Bilirubin (24 mg/dL), Lipemia (3+/4+), Ascorbic Acid (6.0 mg/dL), Urea (500 mg/dL), Uric Acid (40 mg/dL), EDTA (16 mg/dL), Creatinine (40 mg/dL) all passed the interference criteria.
Reagent Stability	Stable on board for 30 days.	Testing established that the GLUH reagent is stable on board for 30 days. Recovered values fell within expected ranges over the testing period.
Calibration Stability	14 days.	The assay was calibrated at 14-day intervals during reagent stability testing, implying successful performance over this period.
Sample Dilution	Saline chosen as appropriate diluent, no issues observed.	Saline was chosen as the appropriate diluent, and "there was no issue or effect observed when verifying saline as an appropriate sample diluent."

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

Method Comparison:
- Serum (DxC 600 & 800): 120 samples each (total 240)
- CSF (DxC 600 & 800): 100 samples each (total 200)
- Urine (DxC 600 & 800): 117 samples each (total 234)
- Total for Method Comparison: 674 samples.
Anticoagulant Studies:
- Sodium Heparin: 79 samples (DxC600), 58 samples (DxC800)
- Lithium Heparin: 79 samples (DxC600), 58 samples (DxC800)
- Sodium Fluoride/Potassium Oxalate: 79 samples (DxC600), 58 samples (DxC800)
- Total for Anticoagulant Studies: (3 * 79) + (3 * 58) = 237 + 174 = 411 samples. (Stated "Over 50 patient specimens with glucose concentrations spanning the analytical range" for each anticoagulant type, then provides N for each DxC system. The cumulative N suggests that these are unique patient specimens across the anticoagulant types but not necessarily all unique for DxC600 vs DxC800)
Precision: 80 data points for each sample type (Control 1, Control 2, Control 3, Pool 1, Pool 2, Pool 3) across Serum, Urine, and CSF, for both DxC 600 and DxC 800. This refers to the number of measurements rather than unique patient samples.
Analytical Sensitivity (LoB, LoD, LoQ): "Multiple urine, CSF and serum pools were run over multiple days". Specific number of samples not given, but refers to "pools."
Linearity: "Multiple replicates of the pools over the range of the assay." Specific number of samples not given, but refers to "pools."
Interferences: "Patient serum pools" used for low, mid, and high glucose levels. Specific number of patient samples not given, but implies multiple pools.
Data Provenance: The document explicitly states "patient correlation studies were conducted using... patient samples" and "paired plasma and serum samples from healthy volunteers." It doesn't specify country of origin but implies clinical laboratory settings. The studies are described as conducted by Beckman Coulter, Inc., suggesting internal testing. The nature of these studies (evaluating device performance against a predicate and known standards) indicates these are primarily prospective data collections for device validation.

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

This type of information (number and qualifications of experts) is generally not applicable or stated for in vitro diagnostic devices like a glucose reagent. The "ground truth" for clinical chemistry assays is established by the reference method (the predicate device in this case) and established analytical techniques and standards (e.g., standard concentrations, known interference levels). Medical professionals use the results, but they don't establish the "ground truth" for the device's technical performance.

4. Adjudication Method

Not applicable for this type of in vitro diagnostic device study. Adjudication methods are typically used in studies involving subjective interpretation, like image analysis by multiple readers.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, which is not relevant for an automated glucose reagent.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are for the standalone performance of the UniCel DxC SYNCHRON Systems Glucose reagent (GLUH) itself, as implemented on the UniCel DxC 600/800 SYNCHRON Systems. The performance data presented (precision, linearity, sensitivity, interference) are direct measurements of the reagent's analytical capability. The method comparison studies compare this standalone performance to that of a predicate device.

7. Type of Ground Truth Used

The ground truth for the test set was established using:

Predicate Device Measurements: For method comparison, the predicate device (SYNCHRON Glucose (GLU) or GLUCm) provided the comparative truth.
Known Concentrations/Reference Standards: For studies like linearity, precision, and analytical sensitivity, the ground truth was based on samples with precisely known glucose concentrations (e.g., control materials, spiked samples, dilutions of high-concentration samples).
Spiked Samples: For interference studies, known interfering substances were added to patient serum pools to create controlled samples with expected values.
Paired Samples: For anticoagulant studies, serum samples (representing the true value) were compared with plasma samples prepared with different anticoagulants.

8. Sample Size for the Training Set

This document only describes performance testing for device validation and substantial equivalence with a predicate device. It does not refer to a "training set" in the context of machine learning. The "training" for such an in vitro diagnostic device involves the chemical formulation of the reagent itself and the engineering of the analyzer system, which would be subject to extensive R&D and internal testing, but not typically documented as a distinct "training set" in this manner for regulatory submission.

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

As mentioned above, there isn't a "training set" in the machine learning sense for this device. The development and optimization of the reagent and system would rely on standard chemical and analytical laboratory practices to ensure accurate and reliable measurements.

Summary

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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	ClassificationPanel	ProductCode
UniCel DxCSYNCHRONSystemsGLUH	Beckman Coulter GLUassay (K883181)	Class II862.1345	75 (ClinicalChemistry)	CFR

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5.0 Description:

Reagent:

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

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 DxCSYNCHRONSystems GLUHReagent	SYNCHRON Systems LX and UniCel DxC GLUreagent (K883181)	List of design inputs that are different between the two reagent devices
Intended Use	Same	Intended for the quantitative determination ofglucose using serum, plasma, urine, or CSF as asample type.	UniCel DxC SYCNHRON SystemsGLUH Reagent	SYNCHRON Systems LX and UniCelDxC GLU'reagent (K883181)
Clinicalindications	Same	Glucose measurements are used in the diagnosisand treatment of carbohydrate metabolismdisorders including diabetes mellitus, neonatalhypoglycemia, idiopathic hypoglycemia, andpancreatic islet cell carcinoma.	Calibrator used	SYNCHRON Systems AQUA CAL 1SYNCHRON Systems AQUA CAL 3(K071277)	SYNCHRON MultiCal (K110251)
Methodology	Same	Timed endpoint method	Calibrator Stability(opened)	30 days	20 days
Reactionprinciple	Same	$ Glucose + ATP → glucose-6-phosphate + ADP Glucose-6-phosphate + NAD+ → 6-phosphogluconate + NADH + H+ $	Interferences
FundamentalTechnology	Same	Spectrophotometric detection	Bilirubin	24 mg/dL	24 mg/dL
System use	Same (NOTE:GLUH is onlyapplied to the DxC600/800 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+) (Humanlipemia)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+, 2.7mmol/L; Hexokinase, 2.0 KIU/L; Glucose-6-phosphate dehydrogenase, 3.0 KIU/L;Also non-reactive chemicals necessary for optimalsystem performance.	Ascorbic Acid	6.0 mg/dL	3.0 mg/dL
ReferenceIntervals	Same	Sample type rangeSerum/plasma 74-106 mg/dLUrine 1-15 mg/dLUrine (timed) <0.5g/24 hoursCSF 40-70 mg/dL	Urea	500 mg/dL	500 mg/dL
Sample Storageand Stability	Same	Serum/plasma1. 8 hours at +20°C to +25°C2. 48 hours at +2°C to +8°C3. > 48 hours at ≤ -15 to -20°CSerum/plasma1. 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 dilutionusing saline for samples exceeding the high end ofthe linear range.	EDTA	16 mg/dL	8 mg/dL
Sample type	Same	Serum/plasma, CSF, urine	Creatinine	40 mg/dL	30 mg/dL
Within runPrecision Claims	Same	SD - 2.0 mg/dLCV - 2.0%	Anticoagulant	Lithium Heparin, Sodium Heparin,Potassium Oxalate/Sodium Fluoride	Ammonium Heparin, Lithium Heparin,Sodium Heparin, PotassiumOxalate/Sodium Fluoride
Total PrecisionClaims	Same	SD - 3.0 mg/dLCV - 3.0%	Sensitivity	≤5 mg/dL	<5mg/dL
Reagent OnBoard Stability	Same	30 days
Calibrationstability	Same	14 days
Within lotcalibration	Same	90 days

List of design inputs that are same/similar between the two reagent devices

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8.0 Summary of Non-clinical Performance Data:

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.

Platform	Sample	Slope	Intercept	R	N
UniCel DxC600	Serum	0.982	-1.02	1.000	120
UniCel DxC800	Serum	0.999	-1.60	1.000	120
UniCel DxC600	CSF	0.978	1.25	1.000	100
UniCel DxC800	CSF	1.002	-0.61	1.000	100

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UniCel DxC600	Urine	0.989	2.08	1.000	117
UniCel DxC800	Urine	0.973	2.86	1.000	117

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
Anticoagulant	N	Deming RegressionAnalysis
Sodium Heparin	79	$y= 0.983 + 0.849, R= 0.999$
Lithium Heparin	79	$y= 0.994 + 0.393, R= 0.999$
Sodium Fluoride/Potassium Oxalate	79	$y= 0.995 + 1.007, R= 0.999$
DxC800
Anticoagulant	N	Deming RegressionAnalysis
Sodium Heparin	58	$y= 0.998 - 0.172, R= 0.999$
Lithium Heparin	58	$y= 1.02 - 2.476, R= 1.000$
Sodium Fluoride/Potassium Oxalate	58	$y= 1.012 - 0.302, R= 0.999$

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.

Type of Imprecision	SAMPLE TYPE	SAMPLE	No. Systems	No. Data Points	GLUHGRANDMEAN(mg/dL)	SD	%CV
Within Run DxC 600	Serum	Control 1	1	80	43	0.7	1.6
	Serum	Control 2	1	80	219	2.3	1.0
	Serum	Control 3	1	80	390	5.7	1.5
	Serum	Pool 1	1	80	9	0.3	3.6
	Serum	Pool 2	1	80	101	1.1	1.1
	Serum	Pool3	1	80	660	6.4	1.0
	Urine	Pool 1	1	80	10	0.3	3.2
	Urine	Pool 2	1	80	95	0.9	1.0
	Urine	Pool 3	1	80	670	5.2	0.8
	CSF	Pool 1	1	80	11	0.3	3.0

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	CSF	Pool 2	1	80	100	1.3	1.2
	CSF	Pool3	1	80	677	7.0	1.0
Total DxC 600	Serum	Control 1	1	80	43	0.8	1 9
	Serum	Control 2	1	80	219	2.6	1.2
	Serum	Control 3	l	80	390	ર. ક	1.7
	Serum	Pool 1	1	80	9	0.6	ਟ: ਰੇ
	Serum	Pool 2	1	80	101	1.6	1.6
	Serum	Pool3	1	80	୧୧୦	8.4	1.3
	Urine	Pool 1	l	80	10	0.6	5.7
	Urine	Pool 2	- J	80	વેટ	1.4	1.5
	Urine	Pool 3	1	80	670	6.1	0.9
	CSF	Pool 1	1	80	11	0.6	5.3
	CSF	Pool 2	1	80	109	1.6	1.5
	CSF	Pool3	1	80	677	8.6	1.3

Type of Imprecision	SAMPLE TYPE	SAMPLE	No. Systems	No. Data Points	GLUH GRANDMEAN (mg/dL)	SD	%CV
Within Run DxC 800	Serum	Control 1	1	80	43	0.5	1.2
	Serum	Control 2	1	80	219	2.7	1.2
	Serum	Control 3	1	80	389	6.3	1.6
	Serum	Pool 1	1	80	9	0.3	3.2
	Serum	Pool 2	1	80	101	1.1	1.1
	Serum	Pool3	1	80	662	7.5	1.1
	Urine	Pool 1	1	80	10	0.3	3.0
	Urine	Pool 2	1	80	94	1.2	1.2
	Urine	Pool 3	1	80	668	7.9	1.2
	CSF	Pool 1	1	80	11	0.3	2.3
	CSF	Pool 2	1	80	108	1.1	1.0
	CSF	Pool3	1	80	680	6.7	1.0
Total DxC 800	Serum	Control 1	1	80	43	0.7	1.7
	Serum	Control 2	1	80	219	3.5	1.6
	Serum	Control 3	1	80	389	7.2	1.9
	Serum	Pool 1	1	80	9	0.3	3.6
	Serum	Pool 2	1	80	101	1.2	1.2
	Serum	Pool3	1	80	662	9.4	1.4
	Urine	Pool 1	1	80	10	0.4	3.7
	Urine	Pool 2	1	80	94	1.3	1.3
	Urine	Pool 3	1	80	668	8.1	1.2
	CSF	Pool 1	1	80	11	0.4	3.6
	CSF	Pool 2	1	80	108	1.7	1.6
	CSF	Pool3	1	80	680	8.1	1.2

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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	CSF	Urine
LoB	0.19 mg/dL	0.17 mg/dL	0.19 mg/dL
	0.011 mmol/L	0.009 mmol/L	0.011 mmol/L
LoD	1.74 mg/dL	1.68 mg/dL	1.78 mg/dL
	0.097 mmol/L	0.093 mmol/L	0.099 mmol/L
LoQ	3.78 mg/dL	3.67 mg/dL	3.69 mg/dL
	0.210 mmol/L	0.204 mmol/L	0.205 mmol/L

Linearity

The study followed CLSI EP-6A. The testing involves running multiple replicates of the pools over the range of the assav. The concentration Recovery error and %Recovery error were calculated for each sample tested. The recovered concentrations verses the Target concentrations are curve fit with first, second, and third order polynomials. The residual differences for each level between the first order (linear) and the better fitting higher order (second or third polynomial) known as the Nonlinearity Differences are calculated. The data substantiates GLUH test is linear between 5 and 700 mg/dL.

The following are the final linear equations obtained for each matrix:

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. The experiment involves adding potential interfering substances to patient serum pools to determine the magnitude of the effect. 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.

Low Level Glucose Pool
Substance	Source	MaximumLevelTested	Target(mg/dL)	Recovered(mg/dL)	%recovery*
Hemoglobin	RBChemolysate	500mg/dL	45.3	43.7	96.5
Bilirubin	Bovine	24 mg/dL	43.4	42.5	97.9
Lipemia	Human	(3+)	46.4	45	97
Serum Index = 6
Ascorbic Acid	NA	6.0 mg/dL	43.7	43.8	100.2
Urea	NA	500 mg/dL	54.7	55.2	100.9
Uric Acid	NA	40 mg/dL	42.9	44.4	103.5
EDTA	NA	16 mg/dL	43.6	43.4	99.5
Creatinine	NA	40 mg/dL	45.2	44.4	98.2
Mid Level Glucose Pool
Substance	Source	Maximum Level Tested	Target (mg/dL)	Recovered (mg/dL)	% recovery*
Hemoglobin	RBC hemolysate	500 mg/dL	171.5	169.1	98.6
Bilirubin	Bovine	24 mg/dL	168.7	167.9	99.5
Lipemia	Human	(4+)Serum Index =>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

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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).

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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)	<0.5g/24 hours
CSF	40-70 mg/dL

Literature References

Tietz, N. W., ed., Fundamentals of Clinical Chemistry, 6th Edition, W. B. Saunders; Philadelphia. PA (2007).

Pagana, K D and Pagana, T J, Mosby's Manual of Diagnostic and Laboratory Tests 3rd Edition , Mosby Inc., St Louis, MO (2006).

9.0 Conclusion:

The data for the UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH), in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the currently cleared SYNCHRON Systems Glucose Reagent (GLU, K883181). Equivalence is demonstrated through method comparison, anticoagulant, precision, sensitivity, linearity, interferences, sample stability, sample dilution, reagent stability, reference range, and calibration stability experiments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

April 17, 2014

BECKMAN COULTER, INC. YVETTE LLOYD 250 S. KRAEMER ST BREA CA 92821

Re: K131189

Trade/Device Name: UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR Dated: April 11, 2014 Received: April 14, 2014

Dear Ms. Lloyd:

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

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Page 2—Ms. Lloyd

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/defauit.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Courtney H. Lias -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131189

Device Name

UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH)

Indications for Use (Describe)

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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.