The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.

The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.

The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.

The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ACE Reagents

The provided 510(k) summary (K113374) describes the performance of four reagents: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, when used with the Alfa Wassermann ACE Axcel Clinical Chemistry System. The study establishes the substantial equivalence of these devices to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "CV must be < X%"). Instead, the performance is reported and compared to the established performance of the predicate device (implied through correlation studies). The key performance metrics are precision (within-run CV and total CV), accuracy (correlation coefficient, standard error estimate, confidence intervals for slope and intercept from regression analysis against a predicate device), and detection limit.

Note: For each analyte, the "acceptance criteria" can be inferred from the reported performance, which demonstrates that the new device performs comparably to the predicate device and within acceptable analytical limits for clinical use. The confidence intervals for the slope and intercept being close to 1 and 0 respectively for accuracy, and low CVs for precision, suggest good performance. A direct numerical acceptance criterion for each metric is not specifically stated in this summary but is inherent in the demonstration of substantial equivalence.

Performance Metric	ACE Albumin Reagent	ACE Total Protein Reagent	ACE Calcium-Arsenazo Reagent	ACE Inorganic Phosphorus U.V. Reagent
Precision
Within-run CV (Lab)	0.9 to 1.7% (at 4 levels)	0.8 to 2.4% (at 4 levels)	1.3 to 2.3% (at 4 levels)	1.4 to 1.9% (at 4 levels)
Total CV (Lab)	1.2 to 2.0% (at 4 levels)	1.0 to 2.9% (at 4 levels)	1.4 to 2.3% (at 4 levels)	1.5 to 2.5% (at 4 levels)
Within-run CV (POL)	0.0 to 1.6% (at 3 sites, 3 levels)	0.7 to 1.3% (at 3 sites, 3 levels)	0.8 to 1.4% (at 3 sites, 3 levels)	0.6 to 3.2% (at 3 sites, 3 levels)
Total CV (POL)	0.0 to 2.3% (at 3 sites, 3 levels)	0.8 to 1.6% (at 3 sites, 3 levels)	1.1 to 2.9% (at 3 sites, 3 levels)	1.0 to 3.9% (at 3 sites, 3 levels)
Accuracy
Correlation Study
Sample Size	118 samples	121 samples	111 samples	110 samples
Range	0.4 to 6.4 g/dL	0.4 to 13.5 g/dL	0.7 to 14.5 mg/dL	0.6 to 19.6 mg/dL
Correlation Coeff.	0.9959	0.9977	0.9935	0.9983
Std Error Est.	0.08	0.12	0.22	0.16
CI Slope	0.980 to 1.013	0.978 to 1.002	0.998 to 1.042	0.994 to 1.017
CI Intercept	-0.04 to 0.10	-0.12 to 0.06	-0.50 to -0.08	-0.06 to 0.05
Patient Corr. (POL)
Correlation Coeff.	0.9894 to 0.9966 (3 sites)	0.9932 to 0.9987 (3 sites)	0.9895 to 0.9977 (3 sites)	0.9977 to 0.9996 (3 sites)
Std Error Est.	0.08 to 0.13 (3 sites)	0.09 to 0.24 (3 sites)	0.16 to 0.23 (3 sites)	0.11 to 0.19 (3 sites)
CI Slope	0.946 to 1.037 (3 sites)	0.973 to 1.047 (3 sites)	0.969 to 1.075 (3 sites)	1.014 to 1.067 (3 sites)
CI Intercept	-0.14 to 0.39 (3 sites)	-0.41 to 0.19 (3 sites)	-0.43 to 0.42 (3 sites)	-0.33 to 0.09 (3 sites)
Detection Limit	0.09 g/dL	0.15 g/dL	0.11 mg/dL	0.07 mg/dL

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

The studies are retrospective in nature, as they involve testing samples on both the new device (ACE Axcel System with new reagents) and a predicate device (Alfa Wassermann ACE Clinical Chemistry System).

The data provenance is not explicitly stated regarding country of origin, but the testing was conducted at "three separate Physician Office Laboratory (POL) sites" in addition to the primary laboratory testing. This suggests the data is from a clinical laboratory environment.

Test Set Sample Sizes:

ACE Albumin Reagent: 118 samples (correlation study)
ACE Total Protein Reagent: 121 samples (correlation study)
ACE Calcium-Arsenazo Reagent: 111 samples (correlation study)
ACE Inorganic Phosphorus U.V. Reagent: 110 samples (correlation study)

These sample sizes were used for the accuracy/correlation studies comparing the new device to the predicate. The precision studies involved testing at 4 levels for 22 days in the main lab and at 3 levels over 5 days at the three POL sites, without specifying the exact number of individual samples for precision.

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

This type of submission (IVD reagent for clinical chemistry) does not typically involve human experts establishing ground truth for individual measurements in the same way an imaging AI might. The "ground truth" for the test set is established by the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. The performance of this predicate device is assumed to be accurate and clinically acceptable, serving as the comparative standard. Therefore, no external experts are explicitly mentioned for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative chemical assay, not an assessment requiring human interpretation or adjudication. The comparison is between quantitative measurements from two different analytical systems.

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 reagent, not an AI imaging or diagnostic algorithm that involves human readers.

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

Yes, the studies evaluate the standalone performance of the ACE Axcel Clinical Chemistry System using the new reagents. The measurements are automated, and the results are directly compared to those obtained from the predicate device. There is no "human-in-the-loop" aspect to the analytical process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these studies is the quantitative measurements obtained from the legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is validated against an already approved method.

8. The sample size for the training set

Not applicable. These are chemical reagents and an associated analyzer system, not a machine learning or AI model that requires a "training set" in the conventional sense. The performance characteristics were determined through analytical studies.

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 technology.

Summary

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K1B374

510(k) SUMMARY

JUL 1 3 2012

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 Summary Prepared:	July 11, 2012
Device:	Trade/Device Name:	ACE Albumin Reagent
	Regulation Number:	21 C.F.R. § 862.1035
	Regulation Name:	Albumin Test System
	Regulatory Class:	Class 2
	Product Code:	CIX
	Common/Classification Name:	Bromcresol Green Dye-Binding,Albumin
	Trade/Device Name:	ACE Total Protein Reagent
	Regulation Number:	21 C.F.R. § 862.1635
	Regulation Name:	Total Protein Test System
	Regulatory Class:	Class 2, Exempt,meets limits of exemptions per21 CFR § 862.9 (c)(9)
	Product Code:	CEK
	Common/Classification Name:	Biuret (Colorimetric), Total Protein
	Trade/Device Name:	ACE Calcium-Arsenazo Reagent
	Regulation Number:	21 C.F.R. § 862.1145
	Regulation Name:	Calcium Test System
	Regulatory Class:	Class 2
	Product Code:	CJY
	Common/Classification Name:	Azo Dye, Calcium

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Trade/Device Name:	ACE Inorganic Phosphorus U.V.Reagent
Regulation Number:	21 C.F.R. § 862.1580
Regulation Name:	Phosphorus (Inorganic) Test System
Regulatory Class:	Class 1, Reserved
Product Code:	CEO
Common/Classification Name:	Phosphomolybdate (Colorimetric),Inorganic Phosphorus
Predicate Devices:	Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Reagents (K931786)
Device Descriptions:	In the ACE Albumin Reagent assay, Bromcresol green binds specifically toalbumin to form a green colored complex, which is measuredbichromatically at 629 nm/692 nm. The intensity of color produced isdirectly proportional to the albumin concentration in the sample.In the ACE Total Protein Reagent assay, cupric ions react with the peptidebonds of proteins under alkaline conditions to form a violet coloredcomplex which is measured bichromatically at 544 nm/692 nm. Theintensity of color produced is directly proportional to the total proteinconcentration in the sample.In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with ArsenazoIII in an acidic solution to form a blue-purple colored complex, which ismeasured bichromatically at 647 nm/692 nm. The intensity of colorproduced is directly proportional to the calcium concentration in the sample.In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidicconditions, inorganic phosphorus in serum reacts with ammoniummolybdate to form an unreduced phosphomolybdate complex, whichabsorbs strongly at 340 nm. The increase in absorbance, measuredbichromatically at 340 nm/378 nm, is directly proportional to the amount ofphosphorus in the sample.
Intended Use:	Indications for Use:The ACE Albumin Reagent is intended for the quantitative determination ofalbumin concentration in serum using the ACE Axcel Clinical ChemistrySystem. Albumin measurements are used in the diagnosis and treatment ofnumerous diseases involving primarily the liver or kidneys. This test isintended for use in clinical laboratories or physician office laboratories. Forin vitro diagnostic use only

・

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	TechnologicalCharacteristics:	The ACE Albumin Reagent consists of a single reagent bottle. The reagentcontains Bromcresol green and acetate buffer.
		The ACE Total Protein Reagent consists of a single reagent bottle. Thereagent contains copper sulfate, sodium potassium tartrate, potassium iodideand sodium hydroxide.
		The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle.The Reagent contains Arsenazo III.
		The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagentbottle. The reagent contains ammonium molybdate and sulfuric acid.
	PerformanceData:	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 Albumin Reagent
		Precision: In testing conducted at four albumin levels for 22 days, thewithin-run CV ranged from 0.9 to 1.7%, and total CV ranged from 1.2 to2.0%. In precision studies at three separate Physician Office Laboratory(POL) sites over 5 days, the within-run CV ranged from 0.0 to 1.6% andtotal CV ranged from 0.0 to 2.3%.
		Accuracy: In the correlation study, 118 samples with albumin valuesranging from 0.4 to 6.4 g/dL were assayed on the Alfa Wassermann ACEAxcel Clinical Chemistry System (y) and the Alfa Wassermann ACEClinical Chemistry System (x). Least squares regression analysis yielded acorrelation coefficient of 0.9959, a standard error estimate of 0.08, aconfidence interval slope of 0.980 to 1.013, and a confidence intervalintercept of -0.04 to 0.10. In patient correlation studies at three separatePOL sites, using the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x),least-squares regression analysis yielded correlation coefficients of 0.9894to 0.9966, standard error estimates of 0.08 to 0.13, confidence intervalslopes of 0.946 to 1.037, and a confidence interval intercepts of -0.14 to0.39.Detection limit: The detection limit was 0.09 g/dL.

		ACE Total Protein Reagent
		Precision: In testing conducted at four total protein levels for 22 days, thewithin-run CV ranged from 0.8 to 2.4%, and total CV ranged from 1.0 to2.9%. In precision studies at three separate Physician Office Laboratory(POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.3% andtotal CV ranged from 0.8 to 1.6%.

1999 - 1999 - 1999

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Accuracy: In the correlation study, 121 samples with total protein values ranging from 0.4 to 13.5 g/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 0.9977, a standard error estimate of 0.12, a confidence interval slope of 0.978 to 1.002, and a confidence interval intercept of -0.12 to 0.06. 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 vielded correlation coefficients of 0.9932 to 0.9987, standard error estimates of 0.09 to 0.24, confidence interval slopes of 0.973 to 1.047, and a confidence interval intercepts of -0.41 to 0.19. .

Detection limit: The detection limit was 0.15 g/dL.

ACE Calcium-Arsenazo Reagent

Precision: In testing conducted at four calcium levels for 22 days, the within-run CV ranged from 1.3 to 2.3%, and total CV ranged from 1.4 to 2.3%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 1.4% and total CV ranged from 1.1 to 2.9%.

Accuracy: In the correlation study, 111 samples with calcium values ranging from 0.7 to 14.5 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 0.9935, a standard error estimate of 0.22, a confidence interval slope of 0.998 to 1.042, and a confidence interval intercept of -0.50 to -0.08. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). least-squares regression analysis yielded correlation coefficients of 0.9895 to 0.9977, standard error estimates of 0.16 to 0.23, confidence interval slopes of 0.969 to 1.075, and a confidence interval intercepts of -0.43 to 0.42.

Detection limit: The detection limit was 0.11 mg/dL.

ACE Inorganic Phosphorus U.V. Reagent

Precision: In testing conducted at four phosphorus levels for 22 days, the within-run CV ranged from 1.4 to 1.9%, and total CV ranged from 1.5 to 2.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.6 to 3.2% and total CV ranged from 1.0 to 3.9%.

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	Accuracy: In the correlation study, 110 samples with phosphorus valuesranging from 0.6 to 19.6 mg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACEClinical Chemistry System (x). Least squares regression analysis yielded acorrelation coefficient of 0.9983, a standard error estimate of 0.16, aconfidence interval slope of 0.994 to 1.017, and a confidence intervalintercept of -0.06 to 0.05. In patient correlation studies at three separatePOL sites, using the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x),least-squares regression analysis yielded correlation coefficients of 0.9977to 0.9996, standard error estimates of 0.11 to 0.19, confidence intervalslopes of 1.014 to 1.067, and a confidence interval intercepts of -0.33 to0.09.
	Detection limit: The detection limit was 0.07 mg/dL.
Conclusions:	Based on the foregoing data, the device is safe and effective. These dataalso indicate substantial equivalence to the predicate device.

Accuracy: In the correlation study, 110 samples with phosphorus valuesranging from 0.6 to 19.6 mg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACEClinical Chemistry System (x). Least squares regression analysis yielded acorrelation coefficient of 0.9983, a standard error estimate of 0.16, aconfidence interval slope of 0.994 to 1.017, and a confidence intervalintercept of -0.06 to 0.05. In patient correlation studies at three separatePOL sites, using the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x),least-squares regression analysis yielded correlation coefficients of 0.9977to 0.9996, standard error estimates of 0.11 to 0.19, confidence intervalslopes of 1.014 to 1.067, and a confidence interval intercepts of -0.33 to0.09.

Detection limit: The detection limit was 0.07 mg/dL.

Conclusions:

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

and the control of the country of the country

Career States of Career

. . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, and its head turned to the right. The seal is black and white.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUL 1 3 2012

Re: K113374

Trade/Device Name: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, ACE Inorganic Phosphorus U.V. Reagent

Regulation Number: 21 CFR§ 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX, CEK, CJY, CEO Dated: May 29, 2012 Received: May 31, 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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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 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/ResourcesforYou/Industry/default.htm

Sincerely yours, -

Signature

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

8 113374 510(k) Number (if known): __

Device Name: ACE Albumin Reagent

The ACE Albumin Reagent is intended for the quantitative Indications for Use: determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Total Protein 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)

Rute Chuler

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

510(k) 113374

Page 1 of 2

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Indications for Use

510(k) Number (if known): K113374

Device Name: ACE Calcium-Arsenazo Reagent

Indications for Use: The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular

contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Inorganic Phosphorus U.V. 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)

Rute C. hulen

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

510(k) 113374

Page 2 of 2

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.