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 TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. 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 Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.

In the ACE Serum Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.

In the ACE Lipase Reagent Assay, serum lipase acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Serum Iron Reagent, and ACE Lipase Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device/Parameter	Acceptance Criteria (Implied)	Reported Device Performance and Confidence Intervals
ACE Direct TIBC Reagent
Precision	Low within-run and total CV for various TIBC levels.	Lab Testing: - Within-run CV: 0.9% to 2.2% - Total CV: 2.0% to 3.3% POL Sites: - Within-run CV: 0.9% to 3.4% - Total CV: 0.9% to 4.1%
Accuracy (Correlation to Predicate)	High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device.	Lab (109 samples): - Correlation Coefficient: 0.9950 - Standard Error Estimate: 9.1 - Confidence Interval Slope: 0.961 to 0.998 - Confidence Interval Intercept: -9.2 to 4.3 POL Sites: - Correlation Coefficients: 0.9902 to 0.9987 - Standard Error Estimates: 6.1 to 11.2 - Confidence Interval Slopes: 0.923 to 1.006 - Confidence Interval Intercepts: -8.2 to 19.4
Detection Limit	Low enough to be clinically useful.	42.21 µg/dL
ACE Serum Iron Reagent
Precision	Low within-run and total CV for various Serum Iron levels.	Lab Testing: - Within-run CV: 1.2% to 5.2% - Total CV: 1.3% to 5.4% POL Sites: - Within-run CV: 1.2% to 4.1% - Total CV: 1.2% to 4.2%
Accuracy (Correlation to Predicate)	High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device.	Lab (130 samples): - Correlation Coefficient: 0.9995 - Standard Error Estimate: 3.3 - Confidence Interval Slope: 1.000 to 1.012 - Confidence Interval Intercept: -2.7 to -1.0 POL Sites: - Correlation Coefficients: 0.9992 to 0.9998 - Standard Error Estimates: 6.1 to 11.2 - Confidence Interval Slopes: 0.997 to 1.041 - Confidence Interval Intercepts: -2.7 to 9.2
Detection Limit	Low enough to be clinically useful.	5.08 µg/dL
ACE Lipase Reagent
Precision	Low within-run and total CV for various lipase levels.	Lab Testing: - Within-run CV: 1.1% to 6.5% - Total CV: 6.0% to 10.7% POL Sites: - Within-run CV: "to 7.3%" (lower bound not specified) - Total CV: 1.9% to 7.3%
Accuracy (Correlation to Predicate)	High correlation coefficient, low standard error, slope near 1, intercept near 0 when compared to predicate device.	Lab (107 samples): - Correlation Coefficient: 0.9980 - Standard Error Estimate: 9.06 - Confidence Interval Slope: 0.970 to 0.994 - Confidence Interval Intercept: 1.97 to 5.97 POL Sites: - Correlation Coefficients: 0.9993 to 0.9997 - Standard Error Estimates: 4.44 to 7.89 - Confidence Interval Slopes: 1.002 to 1.047 - Confidence Interval Intercepts: -4.74 to 3.41
Detection Limit	Low enough to be clinically useful.	10.63 U/L

Note: The acceptance criteria are "implied" because the document primarily presents the results of the performance data without explicitly stating the pre-defined target values or ranges that were aimed for. However, the context of a 510(k) submission requires demonstrating substantial equivalence, meaning the performance should be comparable to the predicate device. Therefore, the reported data, particularly the high correlation coefficients, slopes near 1, and intercepts near 0 for accuracy, indicate that these outcomes met whatever internal acceptance criteria were set for demonstrating equivalency. For precision, low CVs are generally accepted as good performance.

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

ACE Direct Total Iron-Binding Capacity (TIBC) Reagent:
- Sample Size:
  - Accuracy (correlation study): 109 samples
  - Precision (lab): 4 TIBC levels tested for 22 days.
  - Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified, but likely multiple runs per site per day).
- Data Provenance: Not explicitly stated, but the testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. It is not specified if the data is retrospective or prospective, nor the country of origin.
ACE Serum Iron Reagent:
- Sample Size:
  - Accuracy (correlation study): 130 samples
  - Precision (lab): 4 Serum Iron levels tested for 22 days.
  - Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
- Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.
ACE Lipase Reagent:
- Sample Size:
  - Accuracy (correlation study): 107 samples
  - Precision (lab): 3 lipase levels tested for 22 days.
  - Precision (POL sites): 3 separate POL sites, testing over 5 days (number of samples not specified).
- Data Provenance: Not explicitly stated, but testing occurred at "Physician Office Laboratory (POL) sites" and an unnamed central lab. Retrospective or prospective nature and country of origin are not specified.

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

This information is not provided in the given text. The ground truth for these types of in vitro diagnostic tests is typically established by measurements from a reference method or a predicate device. The text indicates that the "Alfa Wassermann ACE Clinical Chemistry System" was used as the comparator (predicate device) (referred to as 'x' in the regression analyses).

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as by human readers of medical images, to resolve discrepancies in diagnoses. These clinical chemistry devices produce quantitative numerical results, which are then compared statistically to a reference method or predicate device, rather than adjudicated.

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

This information is not applicable as the described devices are in vitro diagnostic clinical chemistry reagents and an automated system (ACE Axcel Clinical Chemistry System), not AI-assisted imaging or diagnostic tools designed for human readers to interpret. Therefore, an MRMC study and effects on human reader performance are not relevant to this submission.

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

Yes, the studies described are standalone performance studies of the device and reagents. The ACE Axcel Clinical Chemistry System is an "automated, discrete, bench-top, random access analyzer." The performance data presented (precision, accuracy, detection limit) are measurements of the system's ability to quantitatively determine analytes directly, without a human interpretation step that would introduce a "human-in-the-loop" component in the result generation itself. The results quantify the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth for these studies was established by comparison to a legally marketed predicate device, the "Alfa Wassermann ACE Clinical Chemistry System" (specifically, the ACE Reagents K000781, K944911 run on the K931786 system). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices in 510(k) submissions. The new device's measurements (y) were correlated against the predicate device's measurements (x).

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the context of these types of in vitro diagnostic submissions for clinical chemistry reagents and analyzers. The device described does not employ a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves rigorous internal calibration procedures and validation during its development and manufacturing, which are distinct from the concept of a "training set" for AI/ML models.

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

As explained in point 8, the concept of a "training set" requiring ground truth establishment in this manner is not applicable to this type of device and submission. The device's operational parameters are set through design, engineering, and calibration processes, not machine learning model training.

Summary

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510(k) SUMMARY

Alfa Wassermann Diagnostic Technologies, LLC 510(k) Owner: 4 Henderson Drive West Caldwell, NJ 07006 Contact: Hyman Katz, Ph.D. Phone: 973-852-0158 973-852-0237 Fax: Date Summary March 29, 2012 Updated: Trade Name: ACE Axcel Clinical Chemistry Device: System Classification: Class 1 Common/Classification Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (21 C.F.R. § 862.2610) Product Code JJE Trade Name: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent Classification: Class 1 Common/Classification Name: Direct Total Iron-Binding Capacity (TIBC) (21 C.F.R. § 862.1415) Product Code JMO Trade Name: ACE Serum Iron Reagent Classification: Class 1 Common/Classification Name: Photometric Method, Iron (Non-Heme) (21 C.F.R. § 862.1410) Product Code JIY Trade Name: ACE Lipase Reagent Classification: Class 1 Lipase-Esterase, Enzymatic, Common/Classification Name: Photometric, Lipase (21 C.F.R. § 862.1465)

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	Product Code CHI
Predicate	Manufacturer for analyzer/reagent system predicate:
Devices:	Alfa Wassermann ACE Clinical Chemistry System (K931786)
	ACE Reagents (K000781, K944911)
DeviceDescriptions:	The ACE Axcel Clinical Chemistry System consists of two majorcomponents, the chemistry instrument and an integrated Panel PC. Theinstrument accepts the physical patient samples, performs theappropriate optical or potentiometric measurements on those samplesand communicates that data to an integral Panel PC. The Panel PC useskeyboard or touch screen input to manually enter a variety of data,control and accept data from the instrument, manage and maintainsystem information and generate reports relative to patient status andinstrument performance. The Panel PC also allows remote download ofpatient requisitions and upload of patient results via a standardinterface.
	In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay,Direct TIBC Color Reagent, an acidic buffer containing an iron-bindingdye and ferric chloride, is added to the serum sample. The low pH ofDirect TIBC Color Reagent releases iron from transferrin. The ironthen forms a colored complex with the dye. The colored complex at theend of the first step represents both the serum iron and excess ironalready present in Direct TIBC Color Reagent. Direct TIBC Buffer, aneutral buffer, is then added, shifting the pH and resulting in a largeincrease in the affinity of transferrin for iron. The serum transferrinrapidly binds the iron by abstracting it from the dye-iron complex. Theobserved decrease in absorbance of the colored dye-iron complex isdirectly proportional to the total iron-binding capacity of the serumsample. The absorbance is measured at 647 nm.
	In the ACE Serum Iron Reagent assay, transferrin-bound iron in serumis released at an acidic pH and reduced from ferric to ferrous ions.These ions react with ferrozine to form a violet colored complex, whichis measured bichromatically at 554 nm/692 nm. The intensity of colorproduced is directly proportional to the serum iron concentration.In the ACE Lipase Reagent Assay, serum lipase acts on a naturalsubstrate, 1,2-diglyceride, to liberate 2-monoglyceride. This ishydrolyzed by monoglyceride lipase (a highly specific enzyme formonoglyceride) into glycerol and free fatty acid. Glycerol kinase actson glycerol to form glycerol-3-phosphate, which is in turn acted on byglycerol-3-phosphate oxidase to generate hydrogen peroxide.Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine andTOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into aquinine dye. The rate of formation of the dye, determined
bichromatically at an absorbance of 573 nm/692 nm, is proportional tothe lipase activity in the sample.
Intended Use:	Indications for Use:
	The ACE Axcel Clinical Chemistry System is an automated, discrete,bench-top, random access analyzer that is intended for in vitrodiagnostic use in the quantitative determination of constituents in bloodand other fluids.
	The ACE TIBC Reagent is intended for the quantitative determinationof total iron-binding capacity in serum using the ACE Axcel ClinicalChemistry System. Iron-binding capacity measurements are used in thediagnosis and treatment of anemia. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
	The ACE Serum Iron Reagent is intended for the quantitativedetermination of iron concentration in serum using the ACE AxcelClinical Chemistry System. Iron (non-heme) measurements are used inthe diagnosis and treatment of diseases such as iron deficiency anemia,hemochromatosis (a disease associated with widespread deposit in thetissues of two iron-containing pigments, hemosiderin and hemofuscin,and characterized by pigmentation of the skin), and chronic renaldisease. This test is intended for use in clinical laboratories or physicianoffice laboratories. For in vitro diagnostic use only.
	The ACE Lipase Reagent is intended for the quantitative determinationof lipase activity in serum using the ACE Axcel Clinical ChemistrySystem. Lipase measurements are used in diagnosis and treatment ofdiseases of the pancreas such as acute pancreatitis and obstruction ofthe pancreatic duct. This test is intended for use in clinical laboratoriesor physician office laboratories. For in vitro diagnostic use only.
TechnologicalCharacteristics:	The following is a description of the major features of the ACE AxcelClinical Chemistry System:
	System throughput is approximately 160 test results per hour forroutine, single reagent chemistries. System throughput will behigher 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 duringinstrument operation. Reagent containers are identified by computer coded labels tosimplify system operation. All reagents in the system mustinclude an identification label on the container.
•	Sample and reagent sensing notify the operator of a depleted condition during operation.
•	The system performs analysis at a reaction temperature of 37°C.
•	An electrolyte subsystem capable of measuring sodium, potassium and chloride 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 System optical system is capable of monitoring a maximum of 48 cuvettes at one time.
•	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 Direct TIBC Reagent is composed of two reagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBC Color Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride and acetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer.
The ACE Serum Iron Reagent is composed of two reagent bottles (Buffer and Color Reagent). The Buffer (R1) contains: hydroxylamine hydrochloride, acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine and hydroxylamine hydrochloride.
The ACE Lipase Reagent is composed of two reagent bottles (Lipase Reagent and Lipase Activator Reagent). The Lipase Reagent (R1) contains: 1,2-diglyceride, monoglyceride lipase, glycerol kinase, glycerol-3-phosphate oxidase, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine, ATP, peroxidase and cholic acid. The Lipase Activator
PerformanceData:	Performance data for the Alfa Wassermann ACE Reagents run on theAlfa Wassermann ACE Axcel Clinical Chemistry System includedprecision, accuracy and detection limit data.
	ACE Direct Total Iron-Binding Capacity (TIBC) Reagent
	Precision: In testing conducted at four TIBC levels for 22 days, thewithin-run CV ranged from 0.9 to 2.2% and total CV ranged from 2.0to 3.3%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 0.9to 3.4% and total CV ranged from 0.9 to 4.1%.
	Accuracy: In the correlation study, 109 samples with TIBC valuesranging from 96 to 598 µg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9950, a standard error estimate of9.1, a confidence interval slope of 0.961 to 0.998 and a confidenceinterval intercept of -9.2 to 4.3. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9902 to 0.9987, standard error estimates of6.1 to 11.2, confidence interval slopes of 0.923 to 1.006 and confidenceinterval intercepts of -8.2 to 19.4.
	Detection limit: The detection limit was 42.21 µg/dL.
	ACE Serum Iron Reagent
	Precision: In testing conducted at four Serum Iron levels for 22 days,the within-run CV ranged from 1.2 to 5.2% and total CV ranged from1.3 to 5.4%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 1.2to 4.1% and total CV ranged from 1.2 to 4.2%.
	Accuracy: In the correlation study, 130 samples with Serum Iron valuesranging from 13 to 550 µg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9995, a standard error estimate of3.3, a confidence interval slope of 1.000 to 1.012 and a confidenceinterval intercept of -2.7 to -1.0. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9992 to 0.9998, standard error estimates of6.1 to 11.2, confidence interval slopes of 0.997 to 1.041 and confidence

	interval intercepts of -2.7 to 9.2.
	Detection limit: The detection limit was 5.08 µg/dL.
	ACE Lipase Reagent
	Precision: In testing conducted at three lipase levels for 22 days, thewithin-run CV ranged from 1.1 to 6.5% and total CV ranged from 6.to 10.7%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged fromto 7.3% and total CV ranged from 1.9 to 7.3%.
	Accuracy: In the correlation study, 107 samples with lipase valuesranging from 15.6 to 697.5 U/L were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9980, a standard error estimate9.06, a confidence interval slope of 0.970 to 0.994 and a confidenceinterval intercept of 1.97 to 5.97. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9993 to 0.9997, standard error estimates4.44 to 7.89, confidence interval slopes of 1.002 to 1.047 andconfidence interval intercepts of -4.74 to 3.41.
	Detection limit: The detection limit was 10.63 U/L.
Conclusions:	Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate device.

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the country of the county of the county of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

JUN - 1 2012

Alfa Wassermann Diagnostic Technologies. c/o Hyman Katz, Ph. D. Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006

Re: K113438

Trade/Device Name: ACE Direct Total Iron-Binding capacity (TIBC) Reagent, ACE Serum Iron Reagent, ACE Lipase Reagent

Regulation Number: 21 CFR §862.1415 Iron-Binding Capacity Test Regulation Name: Class I, reserved Regulatory Class: Product Code: JMO, JIY, CHI Dated: May 21, 2012 Received: May 23, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If vou 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 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's 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,

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

510(k) Number (if known): K113438

Device Name: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent

Indications for Use:

Device Name: ACE Serum Iron Reagent

Indications for Use: The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113435

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Indications for Use

510(k) Number (if known): _

Device Name: ACE Lipase 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)

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

.510(k) 113438

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Regulation Number and Section

§ 862.1415 Iron-binding capacity test system.

(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.