ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD by ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.

The ACE Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. 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 in urine using the ACE and ACE Alera Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine in urine using the ACE and ACE Alera Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. 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 urine using the ACE and ACE Alera Clinical Chemistry Systems. 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.

Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Standard is intended for the calibration of quantitative urine reagents on Alfa Wassermann Clinical Chemistry Systems. For in vitro diagnostic use only.

Device Description

In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the urine 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 urine sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the urine sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus 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 urine sample.

The ACE urine standard is a liquid, aqueous-based, ready-to-use calibration solution with known gravimetric concentrations of several analytes.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Alfa Wassermann ACE Reagents and Urine Standard, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the provided document. Instead, the document presents performance data from studies and implies that these results demonstrate substantial equivalence to predicate devices, thus meeting acceptable performance standards. The reported device performance metrics are precision (within-run CV and total CV), accuracy (correlation coefficient, standard error estimate, confidence interval slope, and confidence interval intercept compared to predicate methods), and detection limit.

Table of Acceptance Criteria (Implied) and Reported Device Performance for Urine Analytes

Analyte	Performance Metric	Implied Acceptance Criteria (e.g., comparable to predicate)	Reported Device Performance (ACE System & ACE Alera System)
Urea Nitrogen	Precision (Within-run CV)	Low CV (e.g., ≤ 5%)	Lab: 1.1 - 2.3% (within-run), 2.0 - 3.5% (total CV)POL: 0.9 - 3.8% (within-run), 1.6 - 4.6% (total CV)
	Accuracy (Correlation Coefficient)	High correlation (e.g., ≥ 0.97)	ACE: 0.9769 (r)ACE Alera: 0.9805 (r)POLs: 0.9853 - 0.9895 (r)
	- Standard Error Estimate	Low (e.g., < 100 mg/dL)	ACE: 71.1ACE Alera: 66.2POLs: 61.5 - 75.1
	- Confidence Interval Slope	Close to 1 (e.g., 0.9-1.1)	ACE: 0.871 - 0.945ACE Alera: 0.884 - 0.953POLs: 0.866 - 0.993
	- Confidence Interval Intercept	Close to 0	ACE: 7.9 - 68.9ACE Alera: -5.9 - 50.9POLs: -49.7 - 61.8
	Detection Limit	Low (e.g., < 20 mg/dL)	ACE: 10 mg/dLACE Alera: 14 mg/dL
Calcium	Precision (Within-run CV)	Low CV (e.g., ≤ 7%)	Lab: 1.4 - 5.3% (within-run), 1.6 - 5.7% (total CV)POL: 0.8 - 6.9% (within-run), 0.8 - 7.5% (total CV)
	Accuracy (Correlation Coefficient)	High correlation (e.g., ≥ 0.97)	ACE: 0.9752 (r)ACE Alera: 0.9752 (r)POLs: 0.9669 - 0.9810 (r)
	- Standard Error Estimate	Low (e.g., < 2 mg/dL)	ACE: 1.35ACE Alera: 1.37POLs: 1.35 - 1.70
	- Confidence Interval Slope	Close to 1 (e.g., 0.9-1.1)	ACE: 0.973 - 1.060ACE Alera: 0.979 - 1.066POLs: 0.935 - 1.125
	- Confidence Interval Intercept	Close to 0	ACE: -0.37 - 0.76ACE Alera: -0.46 - 0.66POLs: -1.64 - 1.24
	Detection Limit	Low (e.g., < 0.5 mg/dL)	ACE: 0.3 mg/dLACE Alera: 0.3 mg/dL
Creatinine	Precision (Within-run CV)	Low CV (e.g., < 6%)	Lab: 1.0 - 2.1% (within-run), 2.6 - 3.3% (total CV)POL: 0.8 - 3.5% (within-run), 1.5 - 5.8% (total CV)
	Accuracy (Correlation Coefficient)	High correlation (e.g., ≥ 0.98)	ACE: 0.9818 (r)ACE Alera: 0.9817 (r)POLs: 0.9882 - 0.9904 (r)
	- Standard Error Estimate	Low (e.g., < 15 mg/dL)	ACE: 11.40ACE Alera: 11.95POLs: 10.72 - 12.24
	- Confidence Interval Slope	Close to 1 (e.g., 0.9-1.1)	ACE: 0.950 - 1.021ACE Alera: 0.992 - 1.066POLs: 0.928 - 1.101
	- Confidence Interval Intercept	Close to 0	ACE: 2.62 - 10.92ACE Alera: -3.25 - 5.44POLs: -6.84 - 9.66
	Detection Limit	Low (e.g., < 2 mg/dL)	ACE: 0.8 mg/dLACE Alera: 1.2 mg/dL
Inorganic P	Precision (Within-run CV)	Low CV (e.g., < 5%)	Lab: 0.7 - 2.2% (within-run), 0.8 - 3.4% (total CV)POL: 0.4 - 3.3% (within-run), 0.6 - 4.6% (total CV)
	Accuracy (Correlation Coefficient)	High correlation (e.g., ≥ 0.98)	ACE: 0.9878 (r)ACE Alera: 0.9886 (r)POLs: 0.9809 - 0.9954 (r)
	- Standard Error Estimate	Low (e.g., < 10 mg/dL)	ACE: 5.21ACE Alera: 4.89POLs: 3.88 - 8.40
	- Confidence Interval Slope	Close to 1 (e.g., 0.9-1.1)	ACE: 0.960 - 1.018ACE Alera: 0.940 - 0.995POLs: 0.885 - 1.030
	- Confidence Interval Intercept	Close to 0	ACE: 1.30 - 5.34ACE Alera: 2.06 - 5.91POLs: -1.13 - 7.46
	Detection Limit	Low (e.g., < 2 mg/dL)	ACE: 1.6 mg/dLACE Alera: 1.2 mg/dL

Note: The "Implied Acceptance Criteria" are derived from typical expectations for in vitro diagnostic device performance and the fact that these results were used to demonstrate substantial equivalence to predicate devices.

Study Details

The provided document describes performance studies for the Alfa Wassermann ACE reagents for urine testing, including precision, accuracy, and detection limit data.

Sample sizes used for the test set and the data provenance:
- Urea Nitrogen:
  - Precision: 5 urea nitrogen levels tested for 22 days on 2 instruments. At four separate Physician Office Laboratory (POL) sites, 3 urea nitrogen levels were tested over 5 days.
  - Accuracy:
    - One correlation study: 112 samples (ACE System)
    - Another correlation study: 112 samples (ACE Alera System)
    - Patient correlation studies at four separate POL sites (sample size not specified per site, but implies multiple samples per site).
  - Data Provenance: Not explicitly stated, but clinical laboratories and Physician Office Laboratories (POLs) are mentioned, suggesting real-world clinical samples. The studies are referred to as "patient correlation studies," implying prospective collection or retrospective use of patient samples. The country of origin is not specified.
- Calcium:
  - Precision: 4 calcium levels tested for 22 days on 2 instruments. At four separate POL sites, 3 calcium levels were tested over 5 days.
  - Accuracy:
    - One correlation study: 108 samples (ACE System)
    - Another correlation study: 109 samples (ACE Alera System)
    - Patient correlation studies at four separate POL sites (sample size not specified per site).
  - Data Provenance: Similar to Urea Nitrogen, derived from clinical relevance.
- Creatinine:
  - Precision: 5 creatinine levels tested for 22 days on 2 instruments. At four separate POL sites, 3 creatinine levels were tested over 5 days.
  - Accuracy:
    - One correlation study: 113 samples (ACE System)
    - Another correlation study: 113 samples (ACE Alera System)
    - Patient correlation studies at four separate POL sites (sample size not specified per site).
  - Data Provenance: Similar to Urea Nitrogen.
- Inorganic Phosphorus:
  - Precision: 5 phosphorus levels tested for 22 days on 2 instruments. At four separate POL sites, 3 phosphorus levels were tested over 5 days.
  - Accuracy:
    - One correlation study: 113 samples (ACE System)
    - Another correlation study: 112 samples (ACE Alera System)
    - Patient correlation studies at four separate POL sites (sample size not specified per site).
  - Data Provenance: Similar to Urea Nitrogen.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For in vitro diagnostic devices like these reagents, the "ground truth" for accuracy studies is typically established by comparing the device's results to a "predicate method" (another legally marketed device) or a reference method, rather than expert consensus on individual cases. The document explicitly states comparison to a "predicate method (x)."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image analysis, clinical diagnosis consensus) where human readers are making judgments. For quantitative chemical assays, this type of adjudication is generally not applicable. The comparison is objective, machine-to-machine, or machine-to-reference method.
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:
- No, MRMC studies are not applicable to these types of in vitro diagnostic reagents. These are chemical assays, not AI-powered diagnostic tools that assist human readers. The performance is assessed on the analytical accuracy and precision of the chemical reaction.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented (precision, accuracy, detection limit) are measurements of the reagent system's analytical performance, which operates as a standalone automated assay on the ACE and ACE Alera Clinical Chemistry Systems. Human involvement is in operating the instrument and interpreting the numerical reports, but the core measurement is algorithm-only in the sense of the chemical reaction and photometric measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for accuracy was established by comparing the results of the new ACE reagents to existing predicate devices (Roche Diagnostics COBAS INTEGRA reagents, Siemens Healthcare Diagnostics ADVIA 1800/2400 reagent, Verichem Laboratories, Inc. standard) that are already legally marketed. This is a common approach for demonstrating substantial equivalence for IVD devices.
The sample size for the training set:
- This document describes performance verification studies, not the development or "training" of an AI algorithm or model. Therefore, there is no "training set" in the context of machine learning. The reagents themselves establish the analytical method.
How the ground truth for the training set was established:
- As there is no "training set" in the machine learning sense, this question is not applicable to the presented data. The reagents are chemical formulations, and their manufacturing consistency and analytical performance are verified against defined standards and predicate methods.

Summary

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K 103615

510(k) SUMMARY

SEP - 8 2011

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:	Dec 7, 2010 [Date Updated: August 19, 2011]
Device:	Trade Name:	ACE Urea Nitrogen Reagent
	Classification:	Class 2
	Common/Classification Name:	Urease, Photometric, UreaNitrogen(21 C.F.R. § 862.1770)Product Code CDN
	Trade Name:	ACE Calcium-Arsenazo Reagent
	Classification:	Class 2
	Common/Classification Name:	Azo Dye, Calcium(21 C.F.R. § 862.1145)Product Code CJY
	Trade Name:	ACE Creatinine Reagent
	Classification:	Class 2
	Common/Classification Name:	Alkaline Picrate, Colorimetry,Creatinine (21 C.F.R. § 862.1225)Product Code CGX
	Trade Name:Reagent	ACE Inorganic Phosphorus U.V.
	Classification:	Class 1
	Common/Classification Name:	Phosphomolybdate (Colorimetric),Inorganic Phosphorus(21 C.F.R. § 862.1580)Product Code CEO
	Trade Name:	ACE Urine Standard
	Classification:	Class 2
	Common/Classification Name:	Calibrator, Multianalyte Mixture(21 C.F.R. § 862.1150)Product Code JIX
PredicateDevices:	Manufacturer for the reagent system predicate devices:
	Roche Diagnostics COBAS INTEGRA reagents:
	Reagent	510(k)#
	Urea/BUN	K954000
	Calcium	K896224
	Phosphate (Inorganic) ver.2	K883962
	Siemens Healthcare Diagnostics ADVIA 1800/2400 reagent:
	Reagent	510(k)#
	Creatinine (CRE_2c)	K901229
	Verichem Laboratories, Inc. standard:
	Reagent	510(k)#
	Urine Chemistry Standard	K875285
DeviceDescriptions:	In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed toyield ammonia and carbon dioxide in the presence of urease. Theammonia formed then reacts with 2-oxoglutarate and NADH in thepresence of glutamate dehydrogenase to yield glutamate and NAD.Two moles of NADH are oxidized for each mole of urea present.NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initialrate of decrease in absorbance, monitored bichromatically at 340nm/647 nm, is proportional to the urea concentration in the urinesample.
	In the ACE Calcium-Arsenazo Reagent assay, calcium reacts withArsenazo III in an acidic solution to form a blue-purple coloredcomplex, which is measured bichromatically at 647 nm/692 nm. Theintensity of color produced is directly proportional to the calciumconcentration in the urine sample.
	In the ACE Creatinine Reagent assay, creatinine reacts with picric acidin an alkaline medium to form a red-orange colored complex, whichabsorbs strongly at 505 nm. The rate of complex formation, determinedby measuring the increase in absorbance bichromatically at 505 nm/573nm during a fixed time interval, is directly proportional to thecreatinine concentration in the urine sample.
	In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidicconditions, inorganic phosphorus reacts with ammonium molybdate toform an unreduced phosphomolybdate complex, which absorbsstrongly at 340 nm The increase in absorbance measured
Intended Use:
	bichromatically at 340 nm/378 nm, is directly proportional to theamount of phosphorus in the urine sample.
	The ACE urine standard is a liquid, aqueous-based, ready-to-usecalibration solution with known gravimetric concentrations of severalanalytes.
	Indications for Use:
	The ACE Urea Nitrogen Reagent is intended for the quantitativedetermination of urea nitrogen concentration in serum and urine usingthe ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogenmeasurements are used in the diagnosis and treatment of certain renaland metabolic diseases. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic useonly.
	The ACE Calcium-Arsenazo Reagent is intended for the quantitativedetermination of calcium in serum and urine using the ACE and ACEAlera Clinical Chemistry Systems. Calcium measurements are used inthe diagnosis and treatment of parathyroid disease, a variety of bonediseases, chronic renal disease and tetany. This test is intended for usein clinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
	The ACE Creatinine Reagent is intended for the quantitativedetermination of creatinine in serum and urine using the ACE and ACEAlera Clinical Chemistry Systems. Creatinine measurements are usedin the diagnosis and treatment of renal diseases, in monitoring renaldialysis and as a calculation basis for measuring other urine analytes.This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only.
	The ACE Inorganic Phosphorus U.V. Reagent is intended for thequantitative determination of inorganic phosphorus concentration inserum and urine using the ACE and ACE Alera Clinical ChemistrySystems. Measurements of inorganic phosphorus are used in thediagnosis and treatment of various disorders, including parathyroidgland and kidney diseases and vitamin D imbalance. This test isintended for use in clinical laboratories or physician office laboratories.For in vitro diagnostic use only.
	Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Standardis intended for the calibration of quantitative urine reagents on AlfaWassermann Clinical Chemistry Systems. For in vitro diagnostic useonly.
TechnologicalCharacteristics:	The ACE Urea Nitrogen Reagent consists of a single reagent bottle.The reagent contains α-ketoglutarate, urease, glutamate dehydrogenase,adenosine diphosphate (ADP), nicotinamide adenine dinucleotide andreduced (NADH).
The ACE Calcium-Arsenazo Reagent consists of a single reagentbottle. The Reagent contains Arsenazo III.
The ACE Creatinine Reagent consists of two reagent bottles (SodiumHydroxide Reagent and Picric Acid Reagent). The Sodium HydroxideReagent (R1) contains sodium hydroxide. The Picric Acid Reagent(R2) contains picric acid.
The ACE Inorganic Phosphorus U.V. Reagent consists of a singlereagent bottle. The reagent contains ammonium molybdate and sulfuricacid.
The ACE Urine Standard consists of a single dropper bottle. Thestandard contains known amounts of urea nitrogen, calcium, creatinineand phosphorus.
PerformanceData:	Performance data for the Alfa Wassermann ACE reagents for urinetesting included precision, accuracy and detection limit data.
ACE Urea Nitrogen Reagent
Precision: In testing conducted at five urea nitrogen levels for 22 days,on 2 different instruments, the within-run CV ranged from 1.1 to 2.3%and total CV ranged from 2.0 to 3.5%. In precision studies at three ureanitrogen levels at four separate Physician Office Laboratory (POL) sitesover 5 days, the within-run CV ranged from 0.9 to 3.8% and total CVranged from 1.6 to 4.6%.
Accuracy: In one correlation study, 112 samples with urea nitrogenvalues ranging from 42 to 1883 mg/dL were assayed on the AlfaWassermann ACE System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9769,a standard error estimate of 71.1, a confidence interval slope of 0.871 to0.945 and a confidence interval intercept of 7.9 to 68.9. In anothercorrelation study, 112 samples with urea nitrogen values ranging from48 to 1850 mg/dL were assayed on the Alfa Wassermann ACE AleraClinical Chemistry System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9805,a standard error estimate of 66.2, a confidence interval slope of 0.884 to0.953, and a confidence interval intercept of -5.9 to 50.9. In patientcorrelation studies at four separate POL sites, using the AlfaWassermann ACE reagents and the predicate device (x), least-squaresregression analysis yielded correlation coefficients of 0.9853 to 0.9895,standard error estimates of 61.5 to 75.1, confidence interval slopes of0.866 to 0.993, and confidence interval intercepts of -49.7 to 61.8.

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Detection limit: The detection limit was 10 mg/dL on the ACE and 14mg/dL on the ACE Alera Clinical Chemistry Systems.
ACE Calcium-Arsenazo Reagent
Precision: In testing conducted at four calcium levels for 22 days, on 2different instruments, the within-run CV ranged from 1.4 to 5.3% andtotal CV ranged from 1.6 to 5.7%. In precision studies at three calciumlevels at four separate Physician Office Laboratory (POL) sites over 5days, the within-run CV ranged from 0.8 to 6.9% and total CV rangedfrom 0.8 to 7.5%.
Accuracy: In one correlation study, 108 samples with calcium valuesranging from 1.1 to 28.8 mg/dL were assayed on the Alfa WassermannACE System (y) and the predicate method (x). Least squares regressionanalysis yielded a correlation coefficient of 0.9752, a standard errorestimate of 1.35, a confidence interval slope of 0.973 to 1.060 and aconfidence interval intercept of -0.37 to 0.76. In another correlationstudy, 109 samples with calcium values ranging from 1.0 to 28.8mg/dL were assayed on the Alfa Wassermann ACE Alera ClinicalChemistry System (y) and the predicate method (x). Least squaresregression analysis yielded a correlation coefficient of 0.9752, astandard error estimate of 1.37, a confidence interval slope of 0.979 to1.066 and a confidence interval intercept of -0.46 to 0.66. In patientcorrelation studies at four separate POL sites, using the AlfaWassermann ACE reagents and the predicate device (x), least-squaresregression analysis yielded correlation coefficients of 0.9669 to 0.9810,standard error estimates of 1.35 to 1.70, confidence interval slopes of0.935 to 1.125 and confidence interval intercepts of -1.64 to 1.24.
Detection limit: The detection limit was 0.3 mg/dL on the ACE and 0.3mg/dL on the ACE Alera Clinical Chemistry Systems.
ACE Creatinine Reagent
Precision: In testing conducted at five creatinine levels for 22 days, on2 different instruments, the within-run CV ranged from 1.0 to 2.1% andtotal CV ranged from 2.6 to 3.3%. In precision studies at threecreatinine levels at four separate Physician Office Laboratory (POL)sites over 5 days, the within-run CV ranged from 0.8 to 3.5% and totalCV ranged from 1.5 to 5.8%.
Accuracy: In one correlation study, 113 samples with creatinine valuesranging from 8.2 to 308.7 mg/dL were assayed on the AlfaWassermann ACE System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9818,a standard error estimate of 11.40, a confidence interval slope of 0.950to 1.021 and a confidence interval intercept of 2.62 to 10.92. In anothercorrelation study, 113 samples with creatinine values ranging from 8.5
	to 329.1 mg/dL were assayed on the Alfa Wassermann ACE AleraClinical Chemistry System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9817,a standard error estimate of 11.95, a confidence interval slope of 0.992to 1.066, and a confidence interval intercept of -3.25 to 5.44. In patientcorrelation studies at four separate POL sites, using the AlfaWassermann ACE reagents and the predicate device (x), least-squaresregression analysis yielded correlation coefficients of 0.9882 to 0.9904,standard error estimates of 10.72 to 12.24, confidence interval slopes of0.928 to 1.101 and confidence interval intercepts of -6.84 to 9.66.Detection limit: The detection limit was 0.8 mg/dL on the ACE and 1.2mg/dL on the ACE Alera Clinical Chemistry Systems.
	ACE Inorganic Phosphorus U.V. ReagentPrecision: In testing conducted at five phosphorus levels for 22 days,on 2 different instruments, the within-run CV ranged from 0.7 to 2.2%and total CV ranged from 0.8 to 3.4%. In precision studies at threephosphorus levels at four separate Physician Office Laboratory (POL)sites over 5 days, the within-run CV ranged from 0.4 to 3.3% and totalCV ranged from 0.6 to 4.6%.
	Accuracy: In one correlation study, 113 samples with phosphorusvalues ranging from 6.1 to 182.4 mg/dL were assayed on the AlfaWassermann ACE System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9878,a standard error estimate of 5.21, a confidence interval slope of 0.960 to1.018 and a confidence interval intercept of 1.30 to 5.34. In anothercorrelation study, 112 samples with phosphorus values ranging from5.9 to 175.0 mg/dL were assayed on the Alfa Wassermann ACE AleraClinical Chemistry System (y) and the predicate method (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9886,a standard error estimate of 4.89, a confidence interval slope of 0.940 to0.995 and a confidence interval intercept of 2.06 to 5.91. In patientcorrelation studies at four separate POL sites, using the AlfaWassermann ACE reagents and the predicate device (x), least-squaresregression analysis yielded correlation coefficients of 0.9809 to 0.9954,standard error estimates of 3.88 to 8.40, confidence interval slopes of0.885 to 1.030 and confidence interval intercepts of -1.13 to 7.46.
	Detection limit: The detection limit was 1.6 mg/dL on the ACE and 1.2mg/dL on the ACE Alera Clinical Chemistry Systems.
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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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like strokes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

g, 2011

Re: K103615

Trade/Device Name: ACE Urea Nitrogen Reagent, ACE Calcium Arsenazo Reagent, ACE Creatinine Reagent, ACE Inorganic Phosphorus U.V. Reagent, ACE Urine Standard Regulation Number: 21 CFR $862. 1770 Regulation Name: Urease, Photometric, Urea Regulatory Class: Class II Product Code: CDN, CJY, CGX, CEO, JIX Dated: August 23, 2011 Received: August 24, 2011

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls). 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).

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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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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): ≤ (03 )6 15

Device Name: ACE Urea Nitrogen Reagent

The ACE Urea Nitrogen Reagent is intended for the quantitative Indications for Use: determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Calcium-Arsenazo Reagent

The ACE Calcium-Arsenazo Reagent is intended for the Indications for Use: quantitative determination of calcium in urine using the ACE and ACE Alera Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. 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) 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)

Ruttle Cheler

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

510(k) 1 = 3 6 1 5

Page 1 of 2

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ACE Creatinine Reagent

The ACE Creatinine Reagent is intended for the quantitative Indications for Use: determination of creatinine in urine using the ACE and ACE Alera Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. 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: The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. 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 Name: ACE Urine Standard

Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Indications for Use: Standard is intended for the calibration of quantitative urine reagents on Alfa Wassermann Clinical Chemistry Systems. For in vitro diagnostic use only.

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

Buth Charles

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

1 = 2 6 ( 5 510(k)

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Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.