LogoFDA 510(k) Search
K Number
K123018
Device Name
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
Manufacturer
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
Date Cleared
2013-04-23

(207 days)

Product Code
CFRCEMCGZJGSJJE
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

K113253, K930140, K933862

Not Found

No
The summary describes a standard automated clinical chemistry analyzer using established photometric and potentiometric methods. There is no mention of AI or ML in the device description, intended use, or performance studies.

No.
The ACE Alera Clinical Chemistry System is an in vitro diagnostic device used for quantitative measurements of various analytes in clinical chemistry. It is intended for diagnostic purposes (diagnosis and treatment of diseases) and does not provide therapy or treatment.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use" and describes how the measured analytes (glucose, sodium, potassium, chloride) are used in the "diagnosis and treatment of carbohydrate metabolism disorders," "diseases involving electrolyte imbalance," and other conditions. The "Device Description" also reiterates that it is "intended for in vitro diagnostic use."

No

The device description clearly states that the ACE Alera Clinical Chemistry System consists of a "bench-top analyzer and an internal computer." The description of the bench-top analyzer details physical components like a pipettor, reagent compartment, reaction wheel, and spectrophotometer. This indicates a significant hardware component, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the ACE Alera Clinical Chemistry System is "intended for in vitro diagnostic use".
  • Nature of the Tests: The device performs quantitative measurements of general chemistry assays (glucose, sodium, potassium, chloride) in biological samples (serum and plasma). These types of tests are inherently in vitro diagnostic procedures, as they analyze samples taken from the body outside of the body itself to aid in diagnosis and treatment.
  • Intended Use in Clinical Settings: The device is intended for use in "physician office laboratories or clinical laboratories" for "clinical use," which are typical settings for IVD devices.
  • Reagent and Module Descriptions: The descriptions of the ACE Glucose Reagent and the ACE Ion Selective Electrode (ISE) module also explicitly state "For in vitro diagnostic use only."

All of these points clearly indicate that the ACE Alera Clinical Chemistry System is an In Vitro Diagnostic device.

N/A

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 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.

Product codes (comma separated list FDA assigned to the subject device)

CFR, JGS, CEM, CGZ, JJE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician office laboratories or clinical laboratories.

Description of the training set, sample size, data source, and annotation protocol

Not Found

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)

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry System includes Precision data (Within-Run, Total) for Glucose, Sodium, Potassium, and Chloride at various concentration levels.

Glucose:
Serum Low: ACE Mean 58, Within-Run 0.6 SD, 1.1% CV; Total 0.8 SD, 1.4% CV. Alera Mean 62, Within-Run 0.6 SD, 0.9% CV; Total 0.8 SD, 1.3% CV.
Serum Mid: ACE Mean 158, Within-Run 1.4 SD, 0.9% CV; Total 2.6 SD, 1.7% CV. Alera Mean 121, Within-Run 1.2 SD, 1.0% CV; Total 1.5 SD, 1.3% CV.
Serum High: ACE Mean 273, Within-Run 2.5 SD, 0.9% CV; Total 3.1 SD, 1.2% CV. Alera Mean 366, Within-Run 6.4 SD, 1.8% CV; Total 6.9 SD, 1.9% CV.

Sodium:
Serum Low: ACE Mean 111.4, Within-Run 0.63 SD, 0.6% CV; Total 0.93 SD, 0.8% CV. Alera Mean 111.2, Within-Run 0.59 SD, 0.5% CV; Total 0.93 SD, 0.8% CV.
Serum Mid: ACE Mean 139.1, Within-Run 1.14 SD, 0.8% CV; Total 1.14 SD, 0.8% CV. Alera Mean 139.0, Within-Run 0.80 SD, 0.6% CV; Total 0.87 SD, 0.6% CV.
Serum High: ACE Mean 159.7, Within-Run 0.56 SD, 0.4% CV; Total 0.74 SD, 0.5% CV. Alera Mean 159.9, Within-Run 0.38 SD, 0.2% CV; Total 0.90 SD, 0.6% CV.

Potassium:
Serum Low: ACE Mean 2.1, Within-Run 0.02 SD, 1.0% CV; Total 0.04 SD, 1.6% CV. Alera Mean 2.2, Within-Run 0.04 SD, 1.6% CV; Total 0.05 SD, 2.4% CV.
Serum Mid: ACE Mean 3.9, Within-Run 0.08 SD, 2.0% CV; Total 0.08 SD, 2.0% CV. Alera Mean 4.0, Within-Run 0.07 SD, 1.8% CV; Total 0.07 SD, 1.8% CV.
Serum High: ACE Mean 7.9, Within-Run 0.07 SD, 0.9% CV; Total 0.09 SD, 1.2% CV. Alera Mean 7.9, Within-Run 0.07 SD, 0.9% CV; Total 0.11 SD, 1.4% CV.

Chloride:
Serum Low: ACE Mean 74.7, Within-Run 0.50 SD, 0.7% CV; Total 1.00 SD, 1.3% CV. Alera Mean 75.0, Within-Run 0.80 SD, 1.1% CV; Total 1.50 SD, 2.0% CV.
Serum Mid: ACE Mean 99.1, Within-Run 0.70 SD, 0.7% CV; Total 0.80 SD, 0.8% CV. Alera Mean 99.2, Within-Run 0.80 SD, 0.8% CV; Total 0.90 SD, 0.9% CV.
Serum High: ACE Mean 119.3, Within-Run 0.50 SD, 0.4% CV; Total 0.80 SD, 0.7% CV. Alera Mean 119.3, Within-Run 0.50 SD, 0.4% CV; Total 1.10 SD, 0.9% CV.

POL Precision data for Glucose, Sodium, Potassium, and Chloride from In-House and POL labs 1, 2, and 3. Results show various mean concentrations, within-run SD/%CV, and total SD/%CV for both ACE and ACE Alera systems.

Method Comparison data for Glucose, Sodium, Potassium, and Chloride comparing ACE system In-House data vs. ACE Alera system POL data (2012 Data). Each comparison includes 'n' (sample size), Range, Slope, Intercept, Correlation Coefficient, Std. Error, CI Slope, and CI Intercept for POL 1, POL 2, and POL 3.
Glucose: n=46, Range 22-625 mg/dL. Slopes: 1.015 (POL1), 1.005 (POL2), 0.988 (POL3). Intercepts: 0.1 (POL1), 3.1 (POL2), 3.2 (POL3). Correlation Coefficients: 0.9993 (POL1), 0.9995 (POL2), 0.9993 (POL3).
Sodium: n=42, Range 51-202 mmol/L. Slopes: 1.025 (POL1), 1.021 (POL2), 1.044 (POL3). Intercepts: -1.74 (POL1), -2.92 (POL2), -6.27 (POL3). Correlation Coefficients: 0.9974 (POL1), 0.9958 (POL2), 0.9979 (POL3).
Potassium: n=43, Range 1.8-13.7 mmol/L. Slopes: 1.032 (POL1), 1.008 (POL2), 0.984 (POL3). Intercepts: -0.108 (POL1), -0.054 (POL2), 0.150 (POL3). Correlation Coefficients: 0.9983 (POL1), 0.9971 (POL2), 0.9942 (POL3).
Chloride: n=41, Range 59-187 mmol/L. Slopes: 1.004 (POL1), 1.000 (POL2), 1.006 (POL3). Intercepts: 0.96 (POL1), 0.29 (POL2), 0.16 (POL3). Correlation Coefficients: 0.9972 (POL1), 0.9956 (POL2), 0.9946 (POL3).

Interference studies for Icterus, Hemolysis, Lipemia (Intralipid) (Turbidity), Lipemia (Triglycerides) (Avian), and Ascorbic Acid for GLU, NA, K, and CL tests on the ACE Alera. No significant interference found at or below specified concentrations for each analyte and interferent.
Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence.

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.

K113253, K930140, K933862

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.

Not Found

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.

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510(k) Summary

APR 2 3 2013

510(k) SummaryAPR 2 3 2013
510(k) Owner:Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006
Contact:Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237
Date Summary
Prepared:April 8, 2013
Device:Trade Name:ACE Alera Clinical Chemistry System
Classification:Class 1
Common/Classification Name:Analyzer, Chemistry (Photometric, Discrete), For
Clinical 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
Predicate
Devices:Manufacturer for reagent system predicates:
Alfa Wassermann ACE plus ISE/Clinical Chemistry System
ACE Reagents (K930140, K933862)

1

| Device
Descriptions: | 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 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 Sélective 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. |
| Technological
Characteristics: | The ACE Glucose Reagent consists of a single reagent bottle. The reagent contains
nicotinamide 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 contain
known levels of sodium, potassium and chloride. |

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1000 - 1000

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3

Device . . ... Comparison with Predicate

ACE Alera Clinical Chemistry System

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Comparison of similarities and differences:

| | Candidate Device | Predicate Device
K113253 (ACE Axcel System) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | Clinical chemistry analyzer intended
for the quantitative measurements of
general chemistry assays. For use in
clinical laboratories or physician
office laboratories. | Same |
| Instrument
Platform | ACE Alera Clinical
Chemistry System | ACE Axcel Clinical
Chemistry System |
| Method of
measurements | Potentiometric (ISE) and
photometric chemistries | Same |
| Calibration | same | Automatic |
| Calibration
Stability | same | 3 hrs. STAT READY, as required after
3 hrs. STANDBY. When solution lot
numbers are changed, new electrodes
are installed, major service is
performed 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 Device
ACE Clinical Chemistry Syste
With ISE (K933862) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | For the quantitative
measurements of sodium,
potassium, and chloride in
human serum and lithium
heparin plasma | Same |
| Method | Potentiometric: Ion-selective
electrode | Same |
| Sample Type | Serum and lithium heparin
plasma | Serum |
| Expected
Values | Na: 136-145 mmol/L
K: 3.5-5.1 mmol/L
Cl: 98-107 mmol/L | Same |
| Measuring
range | Na 40-205 mmol/L
K 1.5-15 mmol/L
Cl 50-200 mmol/L | Same |

4

ACE Glucose Reagent

Comparison of similarities and differences:

| GLUCOSE | Candidate Device | Predicate Device
K930104
(ACE Glucose Reagent) |
|----------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended
Use/Indications
for Use | For the quantitative measurement of
glucose in human serum and lithium
heparin plasma | Same |
| Method | Photometric | Same |
| Sample Type | Serum and lithium heparin
plasma | Serum |
| Expected value | 70-105 mg/dL | Serum |
| Measuring range | 4-750 mg/dL | 3-750 mg/dL |

'

5

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)
GlucoseACE MeanWithin-RunTotalAlera MeanWithin-RunTotal
mg/dL
Serum Low580.6, 1.1%0.8, 1.4%620.6, 0.9%0.8, 1.3%
Serum Mid1581.4, 0.9%2.6, 1.7%1211.2, 1.0%1.5, 1.3%
Serum High2732.5, 0.9%3.1, 1.2%3666.4, 1.8%6.9, 1.9%
SodiumACE MeanWithin-RunTotalAlera MeanWithin-RunTotal
mmol/L
Serum Low111.40.63, 0.6%0.93, 0.8%111.20.59, 0.5%0.93, 0.8%
Serum Mid139.11.14, 0.8%1.14, 0.8%139.00.80, 0.6%0.87, 0.6%
Serum High159.70.56, 0.4%0.74, 0.5%159.90.38, 0.2%0.90, 0.6%
PotassiumACE MeanWithin-RunTotalAlera MeanWithin-RunTotal
mmol/L
Serum Low2.10.02, 1.0%0.04, 1.6%2.20.04, 1.6%0.05, 2.4%
Serum Mid3.90.08, 2.0%0.08, 2.0%4.00.07, 1.8%0.07, 1.8%
Serum High7.90.07, 0.9%0.09, 1.2%7.90.07, 0.9%0.11, 1.4%
ChlorideACE MeanWithin-RunTotalAlera MeanWithin-RunTotal
mmol/L
Serum Low74.70.50, 0.7%1.00, 1.3%75.00.80, 1.1%1.50, 2.0%
Serum Mid99.10.70, 0.7%0.80, 0.8%99.20.80, 0.8%0.90, 0.9%
Serum High119.30.50, 0.4%0.80, 0.7%119.30.50, 0.4%1.10, 0.9%

. ..

6

POL Precision
GlucoseACE
SD (mg/dL) or %CVACE Alera
SD (mg/dL) or %CV
LabSampleMeanWithin-RunTotalMeanWithin-RunTotal
In-House163.51.0 SD
1.6%1.2 SD
1.9%62.51.2 SD
1.9%1.3 SD
2.1%
POL 1162.70.6 SD
1.0%1.1 SD
1.7%64.31.1 SD
1.7%1.5 SD
2.3%
POL 2162.50.8 SD
1.3%1.3 SD
2.1%65.30.6 SD
0.9%0.9 SD
1.3%
POL 3163.20.8 SD
1.3%1.1 SD
1.8%64.70.5 SD
0.8%1.0 SD
1.5%
In-House2305.71.3 SD
0.4%2.4 SD
0.8%300.02.4 SD
0.8%4.0 SD
1.3%
POL 12292.83.7 SD
1.3%4.7 SD
1.6%292.14.7 SD
1.6%6.6 SD
2.3%
POL 22298.42.6 SD
0.9%4.9 SD
1.6%296.64.6 SD
1.6%8.1 SD
2.7%
POL 32289.42.0 SD
0.7%4.5 SD
1.6%294.22.1 SD
0.7%4.3 SD
1.5%
In-House3541.15.0 SD
0.9%7.3 SD
1.3%529.85.2 SD
1.0%12.6 SD
2.4%
POL 13508.49.2 SD
1.8%13.1 SD
2.6%500.711.5 SD
2.3%13.8 SD
2.8%
POL 23522.38.7 SD
1.7%11.8 SD
2.3%513.612.4 SD
2.4%13.9 SD
2.7%
POL 33506.83.1 SD
0.6%8.4 SD
1.7%508.84.2 SD
0.8%6.5 SD
1.3%

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7

ACEACE Alera
SodiumSD (mmol/L) or %CVSD (mmol/L) or %CV
LabSampleMeanWithin-RunTotalMeanWithin-RunTotal
In-House1108.10.72 SD0.95 SD107.50.80 SD1.50 SD
0.7%0.9%0.7%1.4%
1.20 SD1.80 SD0.93 SD1.44 SD
POL 11108.71.1%1.6%108.40.9%1.3%
0.90 SD1.70 SD0.94 SD1.16 SD
POL 211080.9%1.6%108.10.9%1.1%
0.60 SD0.90 SD0.56 SD0.98 SD
POL 31109.60.6%0.8%107.00.5%0.9%
0.53 SD0.65 SD0.60 SD0.70 SD
In-House2149.20.4%0.4%149.20.4%0.5%
1.20 SD1.20 SD1.41 SD1.72 SD
POL 12146.90.8%0.8%148.70.9%1.2%
1.00 SD1.00 SD0.56 SD0.80 SD
POL 22149.40.7%0.7%146.10.4%0.5%
1.00 SD1.30 SD0.95 SD0.95 SD
POL 32147.60.7%0.9%147.60.6%0.6%
2.07 SD2.58 SD1.80 SD2.10 SD
In-House3196.41.1%1.3%197.10.9%1.1%
1.70 SD1.90 SD1.33 SD2.74 SD
POL 13190.20.9%1.0%193.70.7%1.4%
1.20 SD2.60 SD0.80 SD1.31 SD
POL 23197.40.6%1.3%189.40.4%0.7%
0.80 SD1.70 SD1.09 SD1.09 SD
POL 33190.60.40%0.9%192.70.6%0.6%
PotassiumACE
SD (mmol/L) or %CVACE Alera
SD (mmol/L) or %CV
LabSampleMeanWithin-RunTotalMeanWithin-RunTotal
In-House13.720.05 SD
1.2%0.05 SD
1.3%3.700.06 SD
1.6%0.06 SD
1.7%
POL 113.780.09 SD
2.4%0.09 SD
2.5%3.730.07 SD
1.8%0.08 SD
2.2%
POL 213.710.02 SD
0.6%0.02 SD
0.6%3.770.06 SD
1.7%0.07 SD
1.8%
POL 313.760.07 SD
1.8%0.07 SD
1.8%3.730.05 SD
1.3%0.06 SD
1.6%
In-House26.520.13 SD
2.0%0.13 SD
2.0%6.560.13 SD
2.0%0.14 SD
2.1%
POL 126.680.08 SD
1.2%0.09 SD
1.4%6.890.13 SD
1.8%0.16 SD
2.4%
POL 226.490.05 SD
0.8%0.05 SD
0.8%6.700.08 SD
1.2%0.09 SD
1.3%
POL 326.740.07 SD
1.0%0.07 SD
1.0%6.670.05 SD
0.8%0.10 SD
1.4%
In-House39.560.11 SD
1.1%0.17 SD
1.8%9.730.09 SD
0.9%0.19 SD
2.0%
POL 139.900.21 SD
2.2%0.22 SD
2.2%10.360.08 SD
0.8%0.19 SD
1.8%
POL 239.560.07 SD
0.8%0.11 SD
1.2%10.040.04 SD
0.4%0.19 SD
1.9%
POL 3310.080.06 SD
0.6%0.11 SD
1.1%9.920.15 SD
1.5%0.22 SD
2.2%

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

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9

ACEACE Alera
ChlorideSD (mmol/L) or %CVSD (mmol/L) or %CV
LabSampleMeanWithin-RunTotalMeanWithin-RunTotal
In-House177.60.37 SD
0.5%0.69 SD
0.9%77.30.50 SD
0.6%1.20 SD
1.6%
POL 1179.21.40 SD
1.8%1.70 SD
2.1%78.10.76 SD
1.0%1.30 SD
1.7%
POL 2178.10.60 SD
0.8%0.70 SD
0.9%78.40.89 SD
1.1%1.24 SD
1.6%
POL 3179.10.90 SD
1.1%1.20 SD
1.5%78.10.48 SD
0.6%0.54 SD
0.7%
In-House2108.21.33 SD
1.2%1.40 SD
1.3%108.31.20 SD
1.1%1.30 SD
1.2%
POL 12108.10.70 SD
0.7%0.80 SD
0.7%109.01.42 SD
1.3%1.42 SD
1.3%
POL 22107.30.40 SD
0.4%0.50 SD
0.5%107.70.69 SD
0.6%0.85 SD
0.8%
POL 32108.20.80 SD
0.7%1.10 SD
1.0%108.20.60 SD
0.6%0.67 SD
0.6%
In-House3142.01.59 SD
1.1%1.81 SD
1.3%143.41.70 SD
1.2%1.80 SD
1.3%
POL 13140.51.50 SD
1.1%1.60 SD
1.2%142.81.11 SD
0.8%2.04 SD
1.4%
POL 23139.80.70 SD
0.5%1.10 SD
0.8%141.20.73 SD
0.5%1.69 SD
1.2%
POL 33140.10.60 SD
0.5%1.10 SD
0.8%142.20.61 SD
0.4%0.75 SD
0.5%

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10

Interferences
ACE AleraIcterusHemolysisLipemia
(Intralipid)
(Turbidity)Lipemia
(Triglycerides)
(Avian)Ascorbic
Acid
GLUNo significant
interference at
or below
26 mg/dLNo significant
interference at
or below
1000 mg/dLNo
significant
interference
at or below
104 mg/dLNo significant
interference at
or below
525 mg/dLNo
significant
interference
at or below
6 mg/dL
NANo significant
interference at
or below
50 mg/dLNo significant
interference at
or below
1000 mg/dLNo
significant
interference
at or below
125 mg/dLNo significant
interference at
or below
656 mg/dLNo
significant
interference
at or below
6 mg/dL
KNo significant
interference at
or below
50 mg/dLNo significant
interference at
or below
125 mg/dLNo
significant
interference
at or below
125 mg/dLNo significant
interference at
or below
420 mg/dLNo
significant
interference
at or below
6 mg/dL
CLNo significant
interference at
or below
50 mg/dLNo significant
interference at
or below
1000 mg/dLNo
significant
interference
at or below
125 mg/dLNo significant
interference at
or below
420 mg/dLNo
significant
interference
at or below
6 mg/dL

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

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11

Method Comparison Data-Ace vs. Alera POL's
Glucosemg/dLACE Alera
POL 1POL 2POL 3
Method
Comparison:
ACE system
In-House vs.n464646
Range (mg/dL)22-62522-62522-625
Slope1.0151.0050.988
ACE Alera
system POL
(2012 Data)Intercept0.13.13.2
Correlation
Coefficient0.99930.99950.9993
Std. Error4.83.94.4
CI Slope1.003 to 1.0270.995 to 1.0150.978 to 0.999
CI Intercept-2.2 to 2.31.3 to 4.91.1 to 5.2
Sodiummmol/LACE Alera
POL 1POL 2POL 3
Method
Comparison:
ACE system
In-House vs.
ACE Alera
system POL
(2012 Data)n424242
Range (mmol/L)51-20251-20251-202
Slope1.0251.0211.044
Intercept-1.74-2.92-6.27
Correlation
Coefficient0.99740.99580.9979
Std. Error2.052.591.87
CI Slope1.001 to 1.0490.991 to 1.0511.022 to 1.06
CI Intercept-5.04 to 1.55-7.08 to 1.24-9.27 to -3.27
Potassiummmol/LACE Alera
POL 1POL 2POL 3
Method
Comparison:
ACE system
In-House vs.
ACE Alera
system POL
(2012 Data)n434343
Range (mmol/L)1.8-13.71.8-13.71.8-13.7
Slope1.0321.0080.984
Intercept-0.108-0.0540.150
Correlation
Coefficient0.99830.99710.9942
Chloride
mmol/LACE Alera
POL 1POL 2POL 3
Method
Comparison:
ACE system
In-House vs.
ACE Alera
system POL
(2012 Data)n414141
Range (mmol/L)59-18759-18759-187
Slope1.0041.0001.006
Intercept0.960.290.16
Correlation
Coefficient0.99720.99560.9946
Std. Error1.692.112.35
CI Slope0.980 to 1.0280.970 to 1.0300.972 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

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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:

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.

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):

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.

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