The ACE Axcel 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 constituents in blood and other fluids.

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.

AI/ML Overview

This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.

Reagent	Metric	Acceptance Criteria (Implicit)	Reported Device Performance (ACE Axcel System)
ACE Carbon Dioxide (CO2-LC) Reagent
Precision - Within-run CV (22 days, 4 levels)	1.6 - 8.7%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.6 - 8.7%
Precision - Total CV (22 days, 4 levels)	4.3 - 12.2%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	4.3 - 12.2%
Precision - Within-run CV (5 days, 3 POL sites)	1.0 - 2.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.0 - 2.6%
Precision - Total CV (5 days, 3 POL sites)	1.8 - 5.7%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.8 - 5.7%
Accuracy - Correlation Coefficient (main study, n=120)	Not explicitly stated, but high correlation with predicate expected	0.9758
Accuracy - Correlation Coefficient (POL studies, 3 sites)	Not explicitly stated, but high correlation with predicate expected	0.9819 to 0.9952
Detection Limit	Not explicitly stated but expected to be clinically acceptable	1.2 mEq/L
ACE Direct Bilirubin Reagent
Precision - Within-run CV (22 days, 4 levels)	0.8 - 16.5%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.8 - 16.5%
Precision - Total CV (22 days, 4 levels)	1.5 - 16.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.5 - 16.6%
Precision - Within-run CV (5 days, 3 POL sites)	0.0 - 4.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.0 - 4.6%
Precision - Total CV (5 days, 3 POL sites)	0.0 - 4.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.0 - 4.6%
Accuracy - Correlation Coefficient (main study, n=116)	Not explicitly stated, but high correlation with predicate expected	0.9996
Accuracy - Correlation Coefficient (POL studies, 3 sites)	Not explicitly stated, but high correlation with predicate expected	0.9996 to 0.9997
Detection Limit	Not explicitly stated but expected to be clinically acceptable	0.1 mg/dL
ACE Total Bilirubin Reagent
Precision - Within-run CV (22 days, 4 levels)	0.6 - 10.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.6 - 10.6%
Precision - Total CV (22 days, 4 levels)	1.1 - 10.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.1 - 10.6%
Precision - Within-run CV (5 days, 3 POL sites)	0.9 - 22.1%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.9 - 22.1%
Precision - Total CV (5 days, 3 POL sites)	0.0 - 3.3%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	0.0 - 3.3%
Accuracy - Correlation Coefficient (main study, n=117)	Not explicitly stated, but high correlation with predicate expected	0.9997
Accuracy - Correlation Coefficient (POL studies, 3 sites)	Not explicitly stated, but high correlation with predicate expected	0.9993 to 1.0000
Detection Limit	Not explicitly stated but expected to be clinically acceptable	0.2 mg/dL
ACE Magnesium Reagent
Precision - Within-run CV (22 days, 4 levels)	2.7 - 5.9%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	2.7 - 5.9%
Precision - Total CV (22 days, 4 levels)	4.1 - 7.6%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	4.1 - 7.6%
Precision - Within-run CV (5 days, 3 POL sites)	1.2 - 4.1%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	1.2 - 4.1%
Precision - Total CV (5 days, 3 POL sites)	2.0 - 6.9%	Not explicitly stated but expected to be comparable to predicate/clinically acceptable	2.0 - 6.9%
Accuracy - Correlation Coefficient (main study, n=108)	Not explicitly stated, but high correlation with predicate expected	0.9690
Accuracy - Correlation Coefficient (POL studies, 3 sites)	Not explicitly stated, but high correlation with predicate expected	0.9858 to 0.9930
Detection Limit	Not explicitly stated but expected to be clinically acceptable	0.2 mg/dL

The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.

2. Sample sizes used for the test set and the data provenance

The studies conducted are primarily accuracy (correlation) and precision studies.

ACE Carbon Dioxide (CO2-LC) Reagent:
- Accuracy (correlation study): 120 samples.
- Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
- Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
ACE Direct Bilirubin Reagent:
- Accuracy (correlation study): 116 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
- Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
ACE Total Bilirubin Reagent:
- Accuracy (correlation study): 117 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
- Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
ACE Magnesium Reagent:
- Accuracy (correlation study): 108 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
- Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.

Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.

4. Adjudication method for the test set

Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human adjudication.

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 a clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.

7. The type of ground truth used

The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of this device.

Summary

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UL 2 2012

510(k) SUMMARY K K 11 3 4 3 5

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:	June 25, 2012
Device:	Trade Name: ACE Axcel Clinical Chemistry SystemClassification: Class 1Common/Classification Name: Analyzer, Chemistry (Photometric, Discrete),For Clinical Use(21 C. F.R. § 862.2610)Product Code JJE
	Trade Name: ACE Carbon Dioxide (CO2-LC) ReagentClassification: Class 2Common/Classification Name: Enzymatic, Carbon-Dioxide(21 C. F.R. § 862.1160)Product Code KHS
	Trade Name: ACE Direct Bilirubin ReagentClassification: Class 2Common/Classification Name: Diazo Colorimetry, Bilirubin(21 C. F.R. § 862.1110)Product Code CIG
	Trade Name: ACE Total Bilirubin ReagentClassification: Class 2Common/Classification Name: Diazo Colorimetry, Bilirubin(21 C. F.R. § 862.1110)Product Code CIG

	Trade Name:	ACE Magnesium Reagent
	Classification:	Class 1
	Common/Classification Name:	Photometric Method, Magnesium(21 C. F.R. § 862.1495)Product Code JGJ
PredicateDevices:	Manufacturer for analyzer/reagent system predicate:	Alfa Wassermann ACE Clinical Chemistry SystemACE Reagents (K931786)
DeviceDescriptions:		The ACE Axcel Clinical Chemistry System consists of two major components,the chemistry instrument and an integrated Panel PC. The instrument accepts thephysical patient samples, performs the appropriate optical or potentiometricmeasurements on those samples and communicates that data to an integral PanelPC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
		In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (inthe form of bicarbonate) reacts with phosphoenolpyruvate in the presence ofphosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid andphosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxi-dized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nmwhereas its oxidized form does not. The rate of decrease in absorbance,monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
		In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acidforms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts withdiazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm.The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
		In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid.forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to formazobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) inthe reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
		Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A

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Intended Use:	Indications for Use:
Intended Use:	The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top,random access analyzer that is intended for in vitro diagnostic use in thequantitative determination of constituents in blood and other fluids.
Intended Use:	The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitativedetermination of carbon dioxide concentration in serum using the ACE AxcelClinical Chemistry System. Bicarbonate/carbon dioxide measurements are usedin the diagnosis and treatment of numerous potentially serious disordersassociated with changes in body acid-base balance. This test is intended for use inclinical laboratories or physician office laboratories. For in vitro diagnostic useonly.
Intended Use:	The ACE Direct Bilirubin Reagent is intended for the quantitative determinationof direct bilirubin concentration in serum using the ACE Axcel ClinicalChemistry System. Measurements of the levels of bilirubin, an organic compoundformed during the normal and abnormal destruction of red blood cells, is used inthe diagnosis and treatment of liver, hemolytic, hematological and metabolicdisorders, including hepatitis and gall bladder block. This test is intended for usein clinical laboratories or physician office laboratories. For in vitro diagnostic useonly.
Intended Use:	The ACE Total Bilirubin Reagent is intended for the quantitative determinationof total bilirubin concentration in serum using the ACE Axcel Clinical ChemistrySystem. Measurements of the levels of bilirubin, an organic compound formedduring the normal and abnormal destruction of red blood cells, is used in thediagnosis and treatment of liver, hemolytic, hematological and metabolicdisorders, including hepatitis and gall bladder block. This test is intended for usein clinical laboratories or physician office laboratories. For in vitro diagnostic useonly.
Intended Use:	The ACE Magnesium Reagent is intended for the quantitative determination ofmagnesium concentration in serum using the ACE Axcel Clinical ChemistrySystem. Magnesium measurements are used in the diagnosis and treatment ofhypomagnesemia (abnormally low serum levels of magnesium) andhypermagnesemia (abnormally high serum levels of magnesium). This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only.

and the state of the state

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Technological	The following is a description of the major features of the ACE Axcel Clinical
Characteristics:	Chemistry System: System throughput is approximately 160 test results per hour for routine,single reagent chemistries. System throughput will be higher when the test
	workload includes ISE's. The instrument has a capacity of 40 reagent containers on board. A reagent
	cooling system maintains the reagents at 12°C during instrument operation. Reagent containers are identified by computer coded labels to simplify
	system operation. All reagents in the system must include an identificationlabel on the container. Sample and reagent sensing notify the operator of a depleted conditionduring operation.
	The system performs analysis at a reaction temperature of 37°C.
	An electrolyte subsystem capable of measuring sodium, potassium andchloride concentrations is included.
	Primary draw tubes may be introduced one at a time into the system for
	closed tube sampling. Positive tube identification can be achieved with an
	optional barcode scanner. An aliquot volume sufficient for all tests ordered
	is transferred and stored and the closed tube is returned to the user.Sample cups are introduced to the system one at a time or by sample ring
	segment.
	Disposable cuvettes are loaded in bulk and then automatically injected as
	needed by a cuvette hopper system. The ACE Axcel clinical chemistry
	optical system is capable of monitoring a maximum of 48 cuvettes at onetime.
	The absorbance optical system is capable of absorbance measurements in a
	linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen
	wavelengths are measured simultaneously using a photodiode array.

	The ACE Carbon Dioxide (CO2-LC) Reagent consists of a single reagent bottle.
	The reagent contains Phosphoenolpyruvate, nicotinamide adenine dinucleotide,analog, reduced, phosphoenol pyruvate carboxylase and malate dehydrogenase.

	The ACE Direct Bilirubin Reagent is composed of two reagent bottles (Direct
	Bilirubin Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilic
	Acid, hydrochloric acid, and sodium nitrite.

	The ACE Total Bilirubin Reagent is composed of two reagent bottles (Total
	Bilirubin Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilicacid, hydrochloric Acid, DMSO and sodium Nitrite.
	The ACE Magnesium Reagent is composed of a single reagent bottle. The
	reagent contains Xylidyl blue-1 and EGTA.

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Performance Data:	Performance data for the Alfa Wassermann ACE Reagents run on the AlfaWassermann ACE Axcel Clinical Chemistry System included precision,accuracy, and detection limit data.
	ACE Carbon Dioxide (CO2-LC) Reagent
	Precision: In testing conducted at four CO2 levels for 22 days, the within-run CVranged from 1.6 to 8.7%, and total CV ranged from 4.3 to 12.2%. In precisionstudies at three separate Physician Office Laboratory (POL) sites over 5 days, thewithin-run CV ranged from 1.0 to 2.6% and total CV ranged from 1.8 to 5.7%.
	Accuracy: In the correlation study, 120 samples with CO2 values ranging from3.2 to 47.6 mEq/L were assayed on the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System(x). Least squares regression analysis yielded a correlation coefficient of 0.9758,a standard error estimate of 1.31, a confidence interval slope of 0.946 to 1.025,and a confidence interval intercept of -1.15 to 0.73. In patient correlation studiesat three separate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System(x), least-squares regression analysis yielded correlation coefficients of 0.9819 to0.9952, standard error estimates of 0.80 to 1.21, confidence interval slopes of0.951 to 1.081, and a confidence interval intercepts of -1.99 to 1.65.
	Detection limit: The detection limit was 1.2 mEq/L.
	ACE Direct Bilirubin Reagent
	Precision: In testing conducted at four direct bilirubin levels for 22 days, thewithin-run CV ranged from 0.8 to 16.5%, and total CV ranged from 1.5 to 16.6%.In precision studies at three separate Physician Office Laboratory (POL) sitesover 5 days, the within-run CV ranged from 0.0 to 4.6% and total CV rangedfrom 0.0 to 4.6%.
	Accuracy: In the correlation study, 116 samples with direct bilirubin valuesranging from 0.2 to 12.5 mg/dL were assayed on the Alfa Wassermann ACEAxcel Clinical Chemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x). Least squares regression analysis yielded a correlationcoefficient of 0.9996, a standard error estimate of 0.05, a confidence intervalslope of 0.967 to 0.978, and a confidence interval intercept of -0.01 to 0.01. Inpatient correlation studies at three separate POL sites, using the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACEClinical Chemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9996 to 0.9997, standard error estimates of 0.07 to0.09, confidence interval slopes of 0.984 to 1.025, and a confidence intervalintercepts of -0.03 to 0.03.
	Detection limit: The detection limit was 0.1 mg/dL.

: .

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ACE Total Bilirubin Reagent

Precision: In testing conducted at four total bilirubin levels for 22 days, the within-run CV ranged from 0.6 to 10.6%, and total CV ranged from 1.1 to 10.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 to 22.1% and total CV ranged from 0.0 to 3.3%.

Accuracy: In the correlation study, 117 samples with total bilirubin values ranging from 0.2 to 34.8 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9997, a standard error estimate of 0.13, a confidence interval slope of 0.961 to 0.970, and a confidence interval intercept of -0.02 to 0.03. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9993 to 1.0000, standard error estimates of 0.08 to 0.25, confidence interval slopes of 1.012 to 1.056, and a confidence interval intercepts of -0.12 to 0.05.

Detection limit: The detection limit was 0.2 mg/dL.

ACE Magnesium Reagent

Precision: In testing conducted at four magnesium levels for 22 days, the withinrun CV ranged from 2.7 to 5.9%, and total CV ranged from 4.1 to 7.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.2 to 4.1% and total CV ranged from 2.0 to 6.9%.

Accuracy: In the correlation study, 108 samples with magnesium values ranging from 0.6 to 5.5 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9690, a standard error estimate of 0.14, a confidence interval slope of 0.950 to 1.046, and a confidence interval intercept of -0.07 to 0.12. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9858 to 0.9930, standard error estimates of 0.11 to 0.18, confidence interval slopes of 0.920 to 1.089, and a confidence interval intercepts of -0.39 to 0.22.

Detection limit: The detection limit was 0.2 mg/dL.

Based on the foregoing data, the device is safe and effective. These data also Conclusions: indicate substantial equivalence to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Alfa Wassermann Diagnostic Technologies, Inc c/o Hyman Katz Ph.D. 4 Henderson Drive West Caldwell, NJ 07006

Re: K113435

Trade Name: ACE Carbon Dioxide (CO2-LC) Reagent ACE Direct Bilirubin Reagent ACE Total Bilirubin Reagent ACE Magnesium Reagent Regulation Number: 21 CFR §862.1160 Regulation Name: Bicarbonate/Carbon-Dioxide test system Regulatory Class: Class II Product Codes: KHS, CIG, JGJ Dated: May 11, 2012 Received: May 14, 2012

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

2 2012 JUL

Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in black and white.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 prease note the regarding postmarket surveillance, please contact CDRH3s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours.

S. H. Liu, Ph.D.

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K113435 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACE Carbon Dioxide (CO2-LC) Reagent

Indications for Use:

Device Name: ACE Direct Bilirubin Reagent

Indications for Use:

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 Diagnostic Devices (OIVD)

Bute Cum

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113435

Page 1 of 2

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACE Total Bilirubin Reagent

Indications for Use:

Device Name: ACE Magnesium Reagent

Indications for Use:

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 Diagnostic Devices (OIVD)

Butte chim

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

k 113435 510(k)

Page 2 of 2

Regulation Number and Section

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.