ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE

Q: Who is the manufacturer of ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE?

Alfa Wassermann Diagnostic Technologies, Inc. filed the 510(k) submission for ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018).

Q: What is the FDA product code for ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE?

CFR. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE?

ACE Axcel Clinical Chemistry System (K113253); ACE plus ISE/Clinical Chemistry System (K930140, K933862); ACE Glucose Reagent (K930104).

Q: Who can help prepare an FDA 510(k) submission like ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K123018 · Alfa Wassermann Diagnostic Technologies, Inc. · CFR · Apr 23, 2013 · Clinical Chemistry

Device Facts

Record ID	K123018
Device Name	ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
Applicant	Alfa Wassermann Diagnostic Technologies, Inc.
Product Code	CFR · Clinical Chemistry
Decision Date	Apr 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2
Attributes	Pediatric

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 Story

Automated, discrete, bench-top, random access clinical chemistry analyzer; includes internal computer, single pipettor, temperature-controlled reagent compartment, reaction wheel, and holographic diffraction grating spectrophotometer. Inputs: serum or lithium heparin plasma samples. Glucose assay: hexokinase/G6PDH enzymatic reaction; NADH production measured bichromatically (340/378 nm). ISE module: potentiometric measurement of Na, K, Cl using ion-specific electrodes and two-point calibration. Used in clinical/physician office labs by laboratory personnel. Output: quantitative concentration values for analytes. Results assist clinicians in diagnosing/monitoring metabolic and electrolyte disorders.

Clinical Evidence

Bench testing only. Precision/reproducibility studies (n=88 per level) and method comparison studies (n=41-46 per analyte) conducted at in-house and physician office laboratory (POL) sites. Linearity confirmed (r2 > 0.999). Matrix comparison (serum vs. lithium heparin plasma) showed high correlation (r > 0.98). Interference testing performed per CLSI EP-7A.

Technological Characteristics

Bench-top analyzer; photometric (holographic diffraction grating) and potentiometric (ISE) sensing. ISE membranes: crown ether (Na), valinomycin (K), quaternary ammonium salts polymer (Cl). Connectivity: on-board computer/monitor. Reagents: liquid-stable in plastic bottles with dot code identification. Automated sample dilution for glucose. Sterilization: not applicable.

Indications for Use

Indicated for quantitative measurement of glucose, sodium, potassium, and chloride in serum and lithium heparin plasma for diagnosis and treatment of metabolic and electrolyte disorders (e.g., diabetes, hypoglycemia, cystic fibrosis, acidosis) in clinical and physician office laboratories.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

ACE Axcel Clinical Chemistry System (K113253)
ACE plus ISE/Clinical Chemistry System (K930140, K933862)
ACE Glucose Reagent (K930104)

Related Devices

K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · May 17, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 100 - 100 , い ## 510(k) Summary APR 2 3 2013 | 510(k) Summary | | | | APR 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. | , 1000 - 1000 . . . . : - : . . {2}------------------------------------------------ . : : : . and the control control control controlled in the controlled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {3}------------------------------------------------ ## Device . . ... Comparison with Predicate ## ACE Alera Clinical Chemistry System ・ベイ・ ## 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) | | | | | | |------------|----------|------------|---------------------|------------|------------|------------|--|--| | 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% | | | . .. {6}------------------------------------------------ | POL Precision | | | | | | | | |---------------|--------------------------|-------|----------------|--------------------------------|-------|-----------------|-----------------| | Glucose | ACE SD (mg/dL) or %CV | | | ACE Alera SD (mg/dL) or %CV | | | | | | | | | | | | | | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | | In-House | 1 | 63.5 | 1.0 SD 1.6% | 1.2 SD 1.9% | 62.5 | 1.2 SD 1.9% | 1.3 SD 2.1% | | POL 1 | 1 | 62.7 | 0.6 SD 1.0% | 1.1 SD 1.7% | 64.3 | 1.1 SD 1.7% | 1.5 SD 2.3% | | POL 2 | 1 | 62.5 | 0.8 SD 1.3% | 1.3 SD 2.1% | 65.3 | 0.6 SD 0.9% | 0.9 SD 1.3% | | POL 3 | 1 | 63.2 | 0.8 SD 1.3% | 1.1 SD 1.8% | 64.7 | 0.5 SD 0.8% | 1.0 SD 1.5% | | In-House | 2 | 305.7 | 1.3 SD 0.4% | 2.4 SD 0.8% | 300.0 | 2.4 SD 0.8% | 4.0 SD 1.3% | | POL 1 | 2 | 292.8 | 3.7 SD 1.3% | 4.7 SD 1.6% | 292.1 | 4.7 SD 1.6% | 6.6 SD 2.3% | | POL 2 | 2 | 298.4 | 2.6 SD 0.9% | 4.9 SD 1.6% | 296.6 | 4.6 SD 1.6% | 8.1 SD 2.7% | | POL 3 | 2 | 289.4 | 2.0 SD 0.7% | 4.5 SD 1.6% | 294.2 | 2.1 SD 0.7% | 4.3 SD 1.5% | | In-House | 3 | 541.1 | 5.0 SD 0.9% | 7.3 SD 1.3% | 529.8 | 5.2 SD 1.0% | 12.6 SD 2.4% | | POL 1 | 3 | 508.4 | 9.2 SD 1.8% | 13.1 SD 2.6% | 500.7 | 11.5 SD 2.3% | 13.8 SD 2.8% | | POL 2 | 3 | 522.3 | 8.7 SD 1.7% | 11.8 SD 2.3% | 513.6 | 12.4 SD 2.4% | 13.9 SD 2.7% | | POL 3 | 3 | 506.8 | 3.1 SD 0.6% | 8.4 SD 1.7% | 508.8 | 4.2 SD 0.8% | 6.5 SD 1.3% | and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co : · - , ・ . . . . . : . . . . . . . . · - ﻴ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , {7}------------------------------------------------ | | 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 | ACE SD (mmol/L) or %CV | | | ACE Alera SD (mmol/L) or %CV | | | | | | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | | | In-House | 1 | 3.72 | 0.05 SD 1.2% | 0.05 SD 1.3% | 3.70 | 0.06 SD 1.6% | 0.06 SD 1.7% | | | POL 1 | 1 | 3.78 | 0.09 SD 2.4% | 0.09 SD 2.5% | 3.73 | 0.07 SD 1.8% | 0.08 SD 2.2% | | | POL 2 | 1 | 3.71 | 0.02 SD 0.6% | 0.02 SD 0.6% | 3.77 | 0.06 SD 1.7% | 0.07 SD 1.8% | | | POL 3 | 1 | 3.76 | 0.07 SD 1.8% | 0.07 SD 1.8% | 3.73 | 0.05 SD 1.3% | 0.06 SD 1.6% | | | In-House | 2 | 6.52 | 0.13 SD 2.0% | 0.13 SD 2.0% | 6.56 | 0.13 SD 2.0% | 0.14 SD 2.1% | | | POL 1 | 2 | 6.68 | 0.08 SD 1.2% | 0.09 SD 1.4% | 6.89 | 0.13 SD 1.8% | 0.16 SD 2.4% | | | POL 2 | 2 | 6.49 | 0.05 SD 0.8% | 0.05 SD 0.8% | 6.70 | 0.08 SD 1.2% | 0.09 SD 1.3% | | | POL 3 | 2 | 6.74 | 0.07 SD 1.0% | 0.07 SD 1.0% | 6.67 | 0.05 SD 0.8% | 0.10 SD 1.4% | | | In-House | 3 | 9.56 | 0.11 SD 1.1% | 0.17 SD 1.8% | 9.73 | 0.09 SD 0.9% | 0.19 SD 2.0% | | | POL 1 | 3 | 9.90 | 0.21 SD 2.2% | 0.22 SD 2.2% | 10.36 | 0.08 SD 0.8% | 0.19 SD 1.8% | | | POL 2 | 3 | 9.56 | 0.07 SD 0.8% | 0.11 SD 1.2% | 10.04 | 0.04 SD 0.4% | 0.19 SD 1.9% | | | POL 3 | 3 | 10.08 | 0.06 SD 0.6% | 0.11 SD 1.1% | 9.92 | 0.15 SD 1.5% | 0.22 SD 2.2% | ・ . • : ・ : : · . : . --- · {8}------------------------------------------------ ১. ::: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : . ・ : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : . -- . {9}------------------------------------------------ | | | | 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 SD 0.5% | 0.69 SD 0.9% | | 77.3 | 0.50 SD 0.6% | 1.20 SD 1.6% | | | | | POL 1 | 1 | 79.2 | 1.40 SD 1.8% | 1.70 SD 2.1% | | 78.1 | 0.76 SD 1.0% | 1.30 SD 1.7% | | | | | POL 2 | 1 | 78.1 | 0.60 SD 0.8% | 0.70 SD 0.9% | | 78.4 | 0.89 SD 1.1% | 1.24 SD 1.6% | | | | | POL 3 | 1 | 79.1 | 0.90 SD 1.1% | 1.20 SD 1.5% | | 78.1 | 0.48 SD 0.6% | 0.54 SD 0.7% | | | | | In-House | 2 | 108.2 | 1.33 SD 1.2% | 1.40 SD 1.3% | | 108.3 | 1.20 SD 1.1% | 1.30 SD 1.2% | | | | | POL 1 | 2 | 108.1 | 0.70 SD 0.7% | 0.80 SD 0.7% | | 109.0 | 1.42 SD 1.3% | 1.42 SD 1.3% | | | | | POL 2 | 2 | 107.3 | 0.40 SD 0.4% | 0.50 SD 0.5% | | 107.7 | 0.69 SD 0.6% | 0.85 SD 0.8% | | | | | POL 3 | 2 | 108.2 | 0.80 SD 0.7% | 1.10 SD 1.0% | | 108.2 | 0.60 SD 0.6% | 0.67 SD 0.6% | | | | | In-House | 3 | 142.0 | 1.59 SD 1.1% | 1.81 SD 1.3% | | 143.4 | 1.70 SD 1.2% | 1.80 SD 1.3% | | | | | POL 1 | 3 | 140.5 | 1.50 SD 1.1% | 1.60 SD 1.2% | | 142.8 | 1.11 SD 0.8% | 2.04 SD 1.4% | | | | | POL 2 | 3 | 139.8 | 0.70 SD 0.5% | 1.10 SD 0.8% | | 141.2 | 0.73 SD 0.5% | 1.69 SD 1.2% | | | | | POL 3 | 3 | 140.1 | 0.60 SD 0.5% | 1.10 SD 0.8% | | 142.2 | 0.61 SD 0.4% | 0.75 SD 0.5% | | | | ، ・ , . ... . : . 1 . · ・ . : {10}------------------------------------------------ | Interferences | | | | | | |---------------|-----------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------| | ACE Alera | Icterus | Hemolysis | Lipemia (Intralipid) (Turbidity) | Lipemia (Triglycerides) (Avian) | Ascorbic Acid | | GLU | No significant interference at or below 26 mg/dL | No significant interference at or below 1000 mg/dL | No significant interference at or below 104 mg/dL | No significant interference at or below 525 mg/dL | No significant interference at or below 6 mg/dL | | NA | No significant interference at or below 50 mg/dL | No significant interference at or below 1000 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 656 mg/dL | No significant interference at or below 6 mg/dL | | K | No significant interference at or below 50 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 420 mg/dL | No significant interference at or below 6 mg/dL | | CL | No significant interference at or below 50 mg/dL | No significant interference at or below 1000 mg/dL | No significant interference at or below 125 mg/dL | No significant interference at or below 420 mg/dL | No significant interference at or below 6 mg/dL | and the same of the same of the same of the same : : : ・・・・ジ : : : · {11}------------------------------------------------ | Method Comparison Data-Ace vs. Alera POL's | | | | | | |-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------|--------------------|----------------|-----------------------------------------------------------------------------------------| | Glucose | mg/dL | ACE Alera | | | | | | | POL 1 | POL 2 | POL 3 | | | Method Comparison: ACE system In-House vs. | n | 46 | 46 | 46 | | | | Range (mg/dL) | 22-625 | 22-625 | 22-625 | | | | Slope | 1.015 | 1.005 | 0.988 | | | ACE Alera system POL (2012 Data) | Intercept | 0.1 | 3.1 | 3.2 | | | | Correlation Coefficient | 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 | | | Method Comparison: ACE system In-House vs. ACE Alera system 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 | | | | Correlation Coefficient | 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 | | | Method Comparison: ACE system In-House vs. ACE Alera system 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 | | | | Correlation Coefficient | 0.9983 | 0.9971 | 0.9942 | | | | Chloride mmol/L | | ACE Alera POL 1 | POL 2 | POL 3 | | | Method Comparison: ACE system In-House vs. ACE Alera system 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 | | | | Correlation Coefficient | 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: 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 Devic…