The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays, such as glucose, sodium, potassium, and chloride, for clinical use in physician office laboratories or clinical laboratories. 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. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ACE Glucose Reagent is intended for the quantitative determination of glucose in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Ion Selective Electrode (ISE) module on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems is used to measure concentrations of sodium, potassium, and chloride in undiluted serum and lithium heparin plasma. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Device Description

The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of general chemistry assays for clinical use in physician office laboratories or clinical laboratories. The ACE Alera Clinical Chemistry System consists of a bench-top analyzer and an internal computer. The bench-top analyzer includes a single pipettor (syringe module/fluid arm/probe), a temperature-controlled reagent compartment, a reaction wheel and a holographic diffraction grating spectrophotometer.

In the ACE Glucose Reagent assay, glucose in serum or heparin plasma reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.

The ACE Ion Selective Electrode (ISE) Module, as part of the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, uses a potentiometric method via ion-specific electrodes to simultaneously measure sodium, potassium and chloride in undiluted serum. Ion-specific membranes measure the difference in ionic concentrations between an inner electrolyte solution and the sample. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. A two-point calibration utilizes ACE CAL A and CAL B undiluted ISE Calibration Solutions with precisely known ion concentrations. The measured voltage difference of the sample and the CAL A and CAL B solutions determines the ion concentration in the sample on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems.

AI/ML Overview

The device is the ACE Alera Clinical Chemistry System, ACE Glucose Reagent, and ACE Ion Selective Electrode (ISE) Module. The study assesses the performance of these components, focusing on the quantitative measurement of glucose, sodium, potassium, and chloride.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets that the device must meet in a formal, quantifiable way (e.g., "Accuracy must be > 95%"). Instead, the study aims to demonstrate substantial equivalence to predicate devices, showing that the performance of the ACE Alera system is comparable to established systems. The performance data presented focuses on precision (reproducibility) and method comparison with existing devices.

Since specific numerical acceptance criteria were not listed, one reasonable interpretation for implied acceptance criteria for laboratory diagnostic devices typically includes:

Acceptable Precision: Coefficients of Variation (CV) or Standard Deviations (SD) for within-run and total precision across different concentration levels should be within generally accepted laboratory limits for each analyte. For clinical chemistry, these are often defined considering medical usefulness.
Acceptable Method Agreement: Linear regression analysis (slope, intercept, correlation coefficient) and standard error between the new device and a reference method (or predicate device) should indicate good agreement. Slopes close to 1, intercepts close to 0, and high correlation coefficients (e.g., >0.975) are generally desired.
No Significant Interference: The device should not be significantly affected by common interfering substances (icterus, hemolysis, lipemia, ascorbic acid) at clinically relevant levels.

Here's the performance data as reported, which serves as the evidence that these implicit acceptance criteria are met:

Analyte	Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (ACE Alera)
Glucose	Precision (SD, %CV)	Low CVs and SDs across different concentrations.	Serum Low (62 mg/dL): Within-Run SD 0.6, CV 0.9%; Total SD 0.8, CV 1.3% Serum Mid (121 mg/dL): Within-Run SD 1.2, CV 1.0%; Total SD 1.5, CV 1.3% Serum High (366 mg/dL): Within-Run SD 6.4, CV 1.8%; Total SD 6.9, CV 1.9%
	POL Precision	Similar precision across different lab settings.	In-House Sample 1 (63.5 mg/dL): Within-Run SD 1.2, CV 1.9%; Total SD 1.3, CV 2.1% POL 1 Sample 1 (64.3 mg/dL): Within-Run SD 1.1, CV 1.7%; Total SD 1.5, CV 2.3% (Similar data for other POLs and samples)
	Method Comparison	Slope close to 1, Intercept close to 0, R > 0.975.	POL 1: Slope 1.015, Intercept 0.1, R 0.9993 POL 2: Slope 1.005, Intercept 3.1, R 0.9995 POL 3: Slope 0.988, Intercept 3.2, R 0.9993
Sodium	Precision (SD, %CV)	Low CVs and SDs across different concentrations.	Serum Low (111.2 mmol/L): Within-Run SD 0.59, CV 0.5%; Total SD 0.93, CV 0.8% Serum Mid (139.0 mmol/L): Within-Run SD 0.80, CV 0.6%; Total SD 0.87, CV 0.6% Serum High (159.9 mmol/L): Within-Run SD 0.38, CV 0.2%; Total SD 0.90, CV 0.6%
	POL Precision	Similar precision across different lab settings.	In-House Sample 1 (107.5 mmol/L): Within-Run SD 0.80 CV 0.7%; Total SD 1.50 CV 1.4% POL 1 Sample 1 (108.4 mmol/L): Within-Run SD 0.93 CV 0.9%; Total SD 1.44 CV 1.3% (Similar data for other POLs and samples)
	Method Comparison	Slope close to 1, Intercept close to 0, R > 0.975.	POL 1: Slope 1.025, Intercept -1.74, R 0.9974 POL 2: Slope 1.021, Intercept -2.92, R 0.9958 POL 3: Slope 1.044, Intercept -6.27, R 0.9979
Potassium	Precision (SD, %CV)	Low CVs and SDs across different concentrations.	Serum Low (2.2 mmol/L): Within-Run SD 0.04, CV 1.6%; Total SD 0.05, CV 2.4% Serum Mid (4.0 mmol/L): Within-Run SD 0.07, CV 1.8%; Total SD 0.07, CV 1.8% Serum High (7.9 mmol/L): Within-Run SD 0.07, CV 0.9%; Total SD 0.11, CV 1.4%
	POL Precision	Similar precision across different lab settings.	In-House Sample 1 (3.70 mmol/L): Within-Run SD 0.06 CV 1.6%; Total SD 0.06 CV 1.7% POL 1 Sample 1 (3.73 mmol/L): Within-Run SD 0.07 CV 1.8%; Total SD 0.08 CV 2.2% (Similar data for other POLs and samples)
	Method Comparison	Slope close to 1, Intercept close to 0, R > 0.975.	POL 1: Slope 1.032, Intercept -0.108, R 0.9983 POL 2: Slope 1.008, Intercept -0.054, R 0.9971 POL 3: Slope 0.984, Intercept 0.150, R 0.9942
Chloride	Precision (SD, %CV)	Low CVs and SDs across different concentrations.	Serum Low (75.0 mmol/L): Within-Run SD 0.80, CV 1.1%; Total SD 1.50, CV 2.0% Serum Mid (99.2 mmol/L): Within-Run SD 0.80, CV 0.8%; Total SD 0.90, CV 0.9% Serum High (119.3 mmol/L): Within-Run SD 0.50, CV 0.4%; Total SD 1.10, CV 0.9%
	POL Precision	Similar precision across different lab settings.	In-House Sample 1 (77.3 mmol/L): Within-Run SD 0.50 CV 0.6%; Total SD 1.20 CV 1.6% POL 1 Sample 1 (78.1 mmol/L): Within-Run SD 0.76 CV 1.0%; Total SD 1.30 CV 1.7% (Similar data for other POLs and samples)
	Method Comparison	Slope close to 1, Intercept close to 0, R > 0.975.	POL 1: Slope 1.004, Intercept 0.96, R 0.9972 POL 2: Slope 1.000, Intercept 0.29, R 0.9956 POL 3: Slope 1.006, Intercept 0.16, R 0.9946
Interference	No significant interference	Thresholds for common interferents.	GLU: No significant interference at or below 26 mg/dL Icterus, 1000 mg/dL Hemolysis, 104 mg/dL Lipemia (Intralipid), 525 mg/dL Lipemia (Triglycerides), 6 mg/dL Ascorbic Acid.(Similar thresholds for Na, K, Cl)

The study essentially acts as a validation against these implied criteria, demonstrating that the ACE Alera system's performance is acceptable for its intended use, comparable to the predicate devices.

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

Precision Studies: The document does not explicitly state the number of individual sample replicates for the core (non-POL) precision studies. However, for the POL Precision studies, for each analyte (Glucose, Sodium, Potassium, Chloride), there were 3 samples tested in each of 4 labs (In-House and 3 POLs). The tables show means, within-run, and total standard deviations/CVs, which typically imply multiple replicates per sample (e.g., 20 or more replicates are common in such studies).
Method Comparison Studies:
- Glucose: n = 46 samples for each of the three POL comparisons.
- Sodium: n = 42 samples for each of the three POL comparisons.
- Potassium: n = 43 samples for each of the three POL comparisons.
- Chloride: n = 41 samples for each of the three POL comparisons.
Data Provenance: The method comparison data is identified as "(2012 Data)" and collected from an "In-House" lab comparing against "ACE Alera system POL" data from three different Physician Office Laboratories (POLs 1, 2, 3), suggesting multi-center evaluation within the United States. The data is retrospective in the sense that it's reported for a 510(k) submission, but the studies themselves would have been conducted prospectively as a part of the device validation. The term "POL" indicates that these are real-world, clinical laboratory settings.

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

There were no human experts establishing ground truth in the context of interpretation for these types of in vitro diagnostic devices. The "ground truth" or reference values for chemical assays like glucose, sodium, potassium, and chloride are established by:

Reference Methods: Often, a more established or gold-standard laboratory analyzer (in this case, the predicate ACE system in the In-House lab) is used to generate the "reference" values for comparison.
Certified Reference Materials: Calibrators and controls with precisely known concentrations are used to calibrate and verify the accuracy of the instruments.

The qualifications of personnel operating these instruments are typically trained medical technologists or clinical laboratory scientists, but they do not establish "ground truth" in the way an expert radiologist might interpret an image.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1 consensus) are used for subjective interpretations, such as medical image analysis, where human experts might disagree. For quantitative chemical measurements, the comparison is directly between numerical results from different instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human interpretation of "cases" or "reads" in the way an MRMC study would evaluate.

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

Yes, the studies presented are essentially standalone performance evaluations of the ACE Alera Clinical Chemistry System, the ACE Glucose Reagent, and the ACE Ion Selective Electrode (ISE) Module. The tables show the performance characteristics (precision, method comparison, interference) of the device itself in generating quantitative results. Human involvement is limited to operating the instrument, performing quality control, and routine maintenance, not subjective interpretation of results. The output (e.g., glucose concentration) is a direct numerical value from the instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the test set (the samples used in the method comparison studies) was established by comparison against a legally marketed predicate device, the Alfa Wassermann ACE system (specifically the ACE plus ISE/Clinical Chemistry System, K930140, K933862), effectively treating the predicate device's measurements as the reference standard. This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning algorithm. For clinical chemistry analyzers, the "training" analogous to machine learning would be:

Instrument Calibration: The device is calibrated using commercially available calibrator solutions with known concentrations. The specific number of calibration points is not detailed but is typically specified by the manufacturer.
Reagent Development and Optimization: The reagents themselves (like ACE Glucose Reagent) undergo extensive development and optimization, which involves testing on numerous samples to establish their performance characteristics (e.g., linearity, stability, interference). The exact sample sizes used during this development are not provided in this regulatory summary.

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

As above, for an IVD analyzer, the "ground truth" for calibration or reagent development typically relies on:

Certified Reference Materials: These are materials with highly accurate and traceable analyte concentrations, used to set the instrument's measurement scale.
Validated Reference Methods: Established laboratory methods, often more complex or time-consuming, that are known to be highly accurate and precise for measuring the analyte.

The document implies that the ground truth for comparison samples was the predicate ACE system, and it is reasonable to assume that the calibration and internal controls for the ACE Alera system would rely on industry-standard reference materials and methods to establish accurate known values.

Summary

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510(k) Summary

APR 2 3 2013

510(k) Summary
510(k) Owner:	Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006
	Contact:	Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237
Date SummaryPrepared:	April 8, 2013
Device:	Trade Name:	ACE Alera Clinical Chemistry System
	Classification:	Class 1
	Common/Classification Name:	Analyzer, Chemistry (Photometric, Discrete), ForClinical Use(21 C.F.R. § 862.2160)Product Code JJE
	Trade Name:	ACE Glucose Reagent
	Classification:	Class 2
	Common/Classification Name:	Hexokinase, Glucose(21 C.F.R. § 862.1345)Product Code CFR
	Trade Name:	ACE Ion Selective Electrode (ISE) Module
	Classification:	Class 2
	Common/Classification Name:Electrode, Ion Specific, Sodium, Potassium,Chloride(21 C.F.R. § 862.1665, 862.1600, 862.1170)Product Codes JGS, CEM, CGZ
PredicateDevices:		Manufacturer for reagent system predicates:
		Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Reagents (K930140, K933862)

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DeviceDescriptions:	The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of general chemistry assays for clinical use in physician office laboratories or clinical laboratories. The ACE Alera Clinical Chemistry System consists of a bench-top analyzer and an internal computer. The bench-top analyzer includes a single pipettor (syringe module/fluid arm/probe), a temperature-controlled reagent compartment, a reaction wheel and a holographic diffraction grating spectrophotometer.In the ACE Glucose Reagent assay, glucose in serum or heparin plasma reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.The ACE Ion Selective Electrode (ISE) Module, as part of the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, uses a potentiometric method via ion-specific electrodes to simultaneously measure sodium, potassium and chloride in undiluted serum. Ion-specific membranes measure the difference in ionic concentrations between an inner electrolyte solution and the sample. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. A two-point calibration utilizes ACE CAL A and CAL B undiluted ISE Calibration Solutions with precisely known ion concentrations. The measured voltage difference of the sample and the CAL A and CAL B solutions determines the ion concentration in the sample on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems.
Intended Use:	Indications for Use:The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays, such as glucose, sodium, potassium, and chloride, for clinical use in physician office laboratories or clinical laboratories. 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. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.




	ACE Glucose Reagent is intended for the quantitative determination of glucose inserum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel ClinicalChemistry Systems. Glucose measurements are used in the diagnosis and treatment ofcarbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia,and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. This test isintended for use in clinical laboratories and physician office laboratories. For in vitrodiagnostic use only.
	The ACE Ion Sélective Electrode (ISE) module on the ACE, ACE Alera, and ACEAxcel Clinical Chemistry Systems is used to measure concentrations of sodium,potassium, and chloride in undiluted serum and lithium heparin plasma.
	Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
	This test is intended for use in clinical laboratories and physician office laboratories.For in vitro diagnostic use only.
TechnologicalCharacteristics:	The ACE Glucose Reagent consists of a single reagent bottle. The reagent containsnicotinamide adenine dinucleotide (NAD), adenosine 5'-triphosphate (ATP),magnesium, hexokinase and glucose-6-phosphate dehydrogenase.
	ACE ISE Module CAL A and CAL B Undiluted ISE Calibration Solution containknown levels of sodium, potassium and chloride.

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Device . . ... Comparison with Predicate

ACE Alera Clinical Chemistry System

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Comparison of similarities and differences:

	Candidate Device	Predicate DeviceK113253 (ACE Axcel System)
Intended Use/Indications forUse	Clinical chemistry analyzer intendedfor the quantitative measurements ofgeneral chemistry assays. For use inclinical laboratories or physicianoffice laboratories.	Same
InstrumentPlatform	ACE Alera ClinicalChemistry System	ACE Axcel ClinicalChemistry System
Method ofmeasurements	Potentiometric (ISE) andphotometric chemistries	Same
Calibration	same	Automatic
CalibrationStability	same	3 hrs. STAT READY, as required after3 hrs. STANDBY. When solution lotnumbers are changed, new electrodesare installed, major service isperformed or a control shift warrants
Sample Volume	same	156 µL
ISE Type	same	Direct (undiluted)

ACE Ion Selective Electrode (ISE) Module

Comparison of similarities and differences:

	Candidate Device	Predicate DeviceACE Clinical Chemistry SysteWith ISE (K933862)
IntendedUse/Indicationsfor Use	For the quantitativemeasurements of sodium,potassium, and chloride inhuman serum and lithiumheparin plasma	Same
Method	Potentiometric: Ion-selectiveelectrode	Same
Sample Type	Serum and lithium heparinplasma	Serum
ExpectedValues	Na: 136-145 mmol/LK: 3.5-5.1 mmol/LCl: 98-107 mmol/L	Same
Measuringrange	Na 40-205 mmol/LK 1.5-15 mmol/LCl 50-200 mmol/L	Same

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ACE Glucose Reagent

Comparison of similarities and differences:

GLUCOSE	Candidate Device	Predicate DeviceK930104(ACE Glucose Reagent)
IntendedUse/Indicationsfor Use	For the quantitative measurement ofglucose in human serum and lithiumheparin plasma	Same
Method	Photometric	Same
Sample Type	Serum and lithium heparinplasma	Serum
Expected value	70-105 mg/dL	Serum
Measuring range	4-750 mg/dL	3-750 mg/dL

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Performance Data:

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry System includes the following data:

			Precision (SD, %CV)
Glucose	ACE Mean	Within-Run	Total	Alera Mean	Within-Run	Total
mg/dL
Serum Low	58	0.6, 1.1%	0.8, 1.4%	62	0.6, 0.9%	0.8, 1.3%
Serum Mid	158	1.4, 0.9%	2.6, 1.7%	121	1.2, 1.0%	1.5, 1.3%
Serum High	273	2.5, 0.9%	3.1, 1.2%	366	6.4, 1.8%	6.9, 1.9%
Sodium	ACE Mean	Within-Run	Total	Alera Mean	Within-Run	Total
mmol/L
Serum Low	111.4	0.63, 0.6%	0.93, 0.8%	111.2	0.59, 0.5%	0.93, 0.8%
Serum Mid	139.1	1.14, 0.8%	1.14, 0.8%	139.0	0.80, 0.6%	0.87, 0.6%
Serum High	159.7	0.56, 0.4%	0.74, 0.5%	159.9	0.38, 0.2%	0.90, 0.6%
Potassium	ACE Mean	Within-Run	Total	Alera Mean	Within-Run	Total
mmol/L
Serum Low	2.1	0.02, 1.0%	0.04, 1.6%	2.2	0.04, 1.6%	0.05, 2.4%
Serum Mid	3.9	0.08, 2.0%	0.08, 2.0%	4.0	0.07, 1.8%	0.07, 1.8%
Serum High	7.9	0.07, 0.9%	0.09, 1.2%	7.9	0.07, 0.9%	0.11, 1.4%
Chloride	ACE Mean	Within-Run	Total	Alera Mean	Within-Run	Total
mmol/L
Serum Low	74.7	0.50, 0.7%	1.00, 1.3%	75.0	0.80, 1.1%	1.50, 2.0%
Serum Mid	99.1	0.70, 0.7%	0.80, 0.8%	99.2	0.80, 0.8%	0.90, 0.9%
Serum High	119.3	0.50, 0.4%	0.80, 0.7%	119.3	0.50, 0.4%	1.10, 0.9%

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POL Precision
Glucose	ACESD (mg/dL) or %CV			ACE AleraSD (mg/dL) or %CV

Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	63.5	1.0 SD1.6%	1.2 SD1.9%	62.5	1.2 SD1.9%	1.3 SD2.1%
POL 1	1	62.7	0.6 SD1.0%	1.1 SD1.7%	64.3	1.1 SD1.7%	1.5 SD2.3%
POL 2	1	62.5	0.8 SD1.3%	1.3 SD2.1%	65.3	0.6 SD0.9%	0.9 SD1.3%
POL 3	1	63.2	0.8 SD1.3%	1.1 SD1.8%	64.7	0.5 SD0.8%	1.0 SD1.5%
In-House	2	305.7	1.3 SD0.4%	2.4 SD0.8%	300.0	2.4 SD0.8%	4.0 SD1.3%
POL 1	2	292.8	3.7 SD1.3%	4.7 SD1.6%	292.1	4.7 SD1.6%	6.6 SD2.3%
POL 2	2	298.4	2.6 SD0.9%	4.9 SD1.6%	296.6	4.6 SD1.6%	8.1 SD2.7%
POL 3	2	289.4	2.0 SD0.7%	4.5 SD1.6%	294.2	2.1 SD0.7%	4.3 SD1.5%
In-House	3	541.1	5.0 SD0.9%	7.3 SD1.3%	529.8	5.2 SD1.0%	12.6 SD2.4%
POL 1	3	508.4	9.2 SD1.8%	13.1 SD2.6%	500.7	11.5 SD2.3%	13.8 SD2.8%
POL 2	3	522.3	8.7 SD1.7%	11.8 SD2.3%	513.6	12.4 SD2.4%	13.9 SD2.7%
POL 3	3	506.8	3.1 SD0.6%	8.4 SD1.7%	508.8	4.2 SD0.8%	6.5 SD1.3%

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	ACE			ACE Alera
Sodium		SD (mmol/L) or %CV		SD (mmol/L) or %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	108.1	0.72 SD	0.95 SD	107.5	0.80 SD	1.50 SD
			0.7%	0.9%		0.7%	1.4%
			1.20 SD	1.80 SD		0.93 SD	1.44 SD
POL 1	1	108.7	1.1%	1.6%	108.4	0.9%	1.3%
			0.90 SD	1.70 SD		0.94 SD	1.16 SD
POL 2	1	108	0.9%	1.6%	108.1	0.9%	1.1%
			0.60 SD	0.90 SD		0.56 SD	0.98 SD
POL 3	1	109.6	0.6%	0.8%	107.0	0.5%	0.9%
			0.53 SD	0.65 SD		0.60 SD	0.70 SD
In-House	2	149.2	0.4%	0.4%	149.2	0.4%	0.5%
			1.20 SD	1.20 SD		1.41 SD	1.72 SD
POL 1	2	146.9	0.8%	0.8%	148.7	0.9%	1.2%
			1.00 SD	1.00 SD		0.56 SD	0.80 SD
POL 2	2	149.4	0.7%	0.7%	146.1	0.4%	0.5%
			1.00 SD	1.30 SD		0.95 SD	0.95 SD
POL 3	2	147.6	0.7%	0.9%	147.6	0.6%	0.6%
			2.07 SD	2.58 SD		1.80 SD	2.10 SD
In-House	3	196.4	1.1%	1.3%	197.1	0.9%	1.1%
			1.70 SD	1.90 SD		1.33 SD	2.74 SD
POL 1	3	190.2	0.9%	1.0%	193.7	0.7%	1.4%
			1.20 SD	2.60 SD		0.80 SD	1.31 SD
POL 2	3	197.4	0.6%	1.3%	189.4	0.4%	0.7%
			0.80 SD	1.70 SD		1.09 SD	1.09 SD
POL 3	3	190.6	0.40%	0.9%	192.7	0.6%	0.6%
	Potassium	ACESD (mmol/L) or %CV			ACE AleraSD (mmol/L) or %CV
	Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
	In-House	1	3.72	0.05 SD1.2%	0.05 SD1.3%	3.70	0.06 SD1.6%	0.06 SD1.7%
	POL 1	1	3.78	0.09 SD2.4%	0.09 SD2.5%	3.73	0.07 SD1.8%	0.08 SD2.2%
	POL 2	1	3.71	0.02 SD0.6%	0.02 SD0.6%	3.77	0.06 SD1.7%	0.07 SD1.8%
	POL 3	1	3.76	0.07 SD1.8%	0.07 SD1.8%	3.73	0.05 SD1.3%	0.06 SD1.6%
	In-House	2	6.52	0.13 SD2.0%	0.13 SD2.0%	6.56	0.13 SD2.0%	0.14 SD2.1%
	POL 1	2	6.68	0.08 SD1.2%	0.09 SD1.4%	6.89	0.13 SD1.8%	0.16 SD2.4%
	POL 2	2	6.49	0.05 SD0.8%	0.05 SD0.8%	6.70	0.08 SD1.2%	0.09 SD1.3%
	POL 3	2	6.74	0.07 SD1.0%	0.07 SD1.0%	6.67	0.05 SD0.8%	0.10 SD1.4%
	In-House	3	9.56	0.11 SD1.1%	0.17 SD1.8%	9.73	0.09 SD0.9%	0.19 SD2.0%
	POL 1	3	9.90	0.21 SD2.2%	0.22 SD2.2%	10.36	0.08 SD0.8%	0.19 SD1.8%
	POL 2	3	9.56	0.07 SD0.8%	0.11 SD1.2%	10.04	0.04 SD0.4%	0.19 SD1.9%
	POL 3	3	10.08	0.06 SD0.6%	0.11 SD1.1%	9.92	0.15 SD1.5%	0.22 SD2.2%

・

. •

・

: .

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::: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

: .

・

-- .

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			ACE				ACE Alera
Chloride			SD (mmol/L) or %CV				SD (mmol/L) or %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	77.6	0.37 SD0.5%	0.69 SD0.9%	77.3	0.50 SD0.6%	1.20 SD1.6%
POL 1	1	79.2	1.40 SD1.8%	1.70 SD2.1%	78.1	0.76 SD1.0%	1.30 SD1.7%
POL 2	1	78.1	0.60 SD0.8%	0.70 SD0.9%	78.4	0.89 SD1.1%	1.24 SD1.6%
POL 3	1	79.1	0.90 SD1.1%	1.20 SD1.5%	78.1	0.48 SD0.6%	0.54 SD0.7%
In-House	2	108.2	1.33 SD1.2%	1.40 SD1.3%	108.3	1.20 SD1.1%	1.30 SD1.2%
POL 1	2	108.1	0.70 SD0.7%	0.80 SD0.7%	109.0	1.42 SD1.3%	1.42 SD1.3%
POL 2	2	107.3	0.40 SD0.4%	0.50 SD0.5%	107.7	0.69 SD0.6%	0.85 SD0.8%
POL 3	2	108.2	0.80 SD0.7%	1.10 SD1.0%	108.2	0.60 SD0.6%	0.67 SD0.6%
In-House	3	142.0	1.59 SD1.1%	1.81 SD1.3%	143.4	1.70 SD1.2%	1.80 SD1.3%
POL 1	3	140.5	1.50 SD1.1%	1.60 SD1.2%	142.8	1.11 SD0.8%	2.04 SD1.4%
POL 2	3	139.8	0.70 SD0.5%	1.10 SD0.8%	141.2	0.73 SD0.5%	1.69 SD1.2%
POL 3	3	140.1	0.60 SD0.5%	1.10 SD0.8%	142.2	0.61 SD0.4%	0.75 SD0.5%

・

...

・

. :

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Interferences
ACE Alera	Icterus	Hemolysis	Lipemia(Intralipid)(Turbidity)	Lipemia(Triglycerides)(Avian)	AscorbicAcid
GLU	No significantinterference ator below26 mg/dL	No significantinterference ator below1000 mg/dL	Nosignificantinterferenceat or below104 mg/dL	No significantinterference ator below525 mg/dL	Nosignificantinterferenceat or below6 mg/dL
NA	No significantinterference ator below50 mg/dL	No significantinterference ator below1000 mg/dL	Nosignificantinterferenceat or below125 mg/dL	No significantinterference ator below656 mg/dL	Nosignificantinterferenceat or below6 mg/dL
K	No significantinterference ator below50 mg/dL	No significantinterference ator below125 mg/dL	Nosignificantinterferenceat or below125 mg/dL	No significantinterference ator below420 mg/dL	Nosignificantinterferenceat or below6 mg/dL
CL	No significantinterference ator below50 mg/dL	No significantinterference ator below1000 mg/dL	Nosignificantinterferenceat or below125 mg/dL	No significantinterference ator below420 mg/dL	Nosignificantinterferenceat or below6 mg/dL

and the same of the same of the same of the same

: : :

・・・・ジ

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Method Comparison Data-Ace vs. Alera POL's
Glucose	mg/dL	ACE Alera
		POL 1	POL 2	POL 3
MethodComparison:ACE systemIn-House vs.	n	46	46	46
	Range (mg/dL)	22-625	22-625	22-625
	Slope	1.015	1.005	0.988
ACE Alerasystem POL(2012 Data)	Intercept	0.1	3.1	3.2
	CorrelationCoefficient	0.9993	0.9995	0.9993
	Std. Error	4.8	3.9	4.4
	CI Slope	1.003 to 1.027	0.995 to 1.015	0.978 to 0.999
	CI Intercept	-2.2 to 2.3	1.3 to 4.9	1.1 to 5.2
Sodium	mmol/L	ACE Alera
		POL 1	POL 2	POL 3
MethodComparison:ACE systemIn-House vs.ACE Alerasystem POL(2012 Data)	n	42	42	42
	Range (mmol/L)	51-202	51-202	51-202
	Slope	1.025	1.021	1.044
	Intercept	-1.74	-2.92	-6.27
	CorrelationCoefficient	0.9974	0.9958	0.9979
	Std. Error	2.05	2.59	1.87
	CI Slope	1.001 to 1.049	0.991 to 1.051	1.022 to 1.06
	CI Intercept	-5.04 to 1.55	-7.08 to 1.24	-9.27 to -3.27
Potassium	mmol/L	ACE Alera
		POL 1	POL 2	POL 3
MethodComparison:ACE systemIn-House vs.ACE Alerasystem POL(2012 Data)	n	43	43	43
	Range (mmol/L)	1.8-13.7	1.8-13.7	1.8-13.7
	Slope	1.032	1.008	0.984
	Intercept	-0.108	-0.054	0.150
	CorrelationCoefficient	0.9983	0.9971	0.9942
	Chloridemmol/L		ACE AleraPOL 1	POL 2	POL 3
	MethodComparison:ACE systemIn-House vs.ACE Alerasystem POL(2012 Data)	n	41	41	41
		Range (mmol/L)	59-187	59-187	59-187
		Slope	1.004	1.000	1.006
		Intercept	0.96	0.29	0.16
		CorrelationCoefficient	0.9972	0.9956	0.9946
		Std. Error	1.69	2.11	2.35
		CI Slope	0.980 to 1.028	0.970 to 1.030	0.972 to 1.040
		CI Intercept	-1.68 to 3.60	-3.02 to 3.60	-3.52 to 3.85

					Based on the foregoing data, the device is safe and effective. These data also indicate

Std. Error

CI Slope

CI Intercept

0.131

1.013 to 1.051

-0.212 to -0.005

0.166

0.984 to 1.032

-0.185 to 0.077

' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '

0.230

0.95 l to 1.018

-0.031 to 0.332

{12}------------------------------------------------

and the comments of the comments of the country of

. .

・

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{13}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

April 23, 2013

Alfa Wasserman Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006

Re: K123018

Trade/Device Name: ACE Alera Clinical Chemistry System

ACE Glucose Reagent

ACE Ion Selective Electrode (ISE) Module

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS, CEM, CGZ, JJE Dated: February 27, 2013 Received: March 5, 2013

Dear Dr. Katz:

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 Part 801); 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.

{14}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -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

{15}------------------------------------------------

Indications for Use

510(k) Number (if known): K123018

Device Name: ACE Alera Clinical Chemistry System, ACE Glucose Reagent, ACE Ion Selective Electrode (ISE) Module

Indications for Use:

. 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.
. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and . · metabolic disorders such as cystic fibrosis and diabetic acidosis.

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

Over-The-Counter Use. (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)

YungWDCchan-S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K123018

Page 1 of 2

{16}------------------------------------------------

Indications for Use

510(k) Number (if known):

Sodium measurements are used in the diagnosis and treatment of diseases involving . electrolyte imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and . treatment of disease conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and . metabolic disorders such as cystic fibrosis and diabetic acidosis.

This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

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

Over-The-Counter Use. (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)

YungW.Chan -S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K123018

Page 2 of 2

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.