The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN 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 Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel 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 Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed in the presence of urease to yield ammonia and carbon dioxide. The ammonia formed then reacts in the presence of glutamate dehydrogenase with 2-oxoglutarate and NADH to yield glutamate and NAD. 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 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 sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed is determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, and is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

AI/ML Overview

Here's a summary of the acceptance criteria and supporting studies for the Alfa Wassermann ACE Reagents (BUN/Urea, Creatinine, Uric Acid, CK), based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from comparisons to a predicate device (Alfa Wassermann ACE K930104 reagents) and performance characteristics such as precision, accuracy (correlation/regression with predicate), linearity, detection limits, and interference. The reported device performance is from in-house studies and Point-of-Care (POL) studies.

Note: The document does not explicitly state "acceptance criteria" numerical targets. Instead, it presents performance data for the candidate device, implying that the data's comparability to the predicate and established analytical standards is the basis for acceptance. I will present the reported performance, which demonstrates the device's meeting the necessary equivalency.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Candidate Device)
Intended Use	Same as predicate (quantitative determination in serum)	BUN: Quantitative determination in serum and lithium heparin plasma. Creatinine: Quantitative determination in serum and lithium heparin plasma. Uric Acid: Quantitative determination in serum and lithium heparin plasma. CK: Quantitative determination in serum and lithium heparin plasma. (Extended to lithium heparin plasma compared to predicate, requiring performance studies in this matrix)
Platforms	Compatible with ACE Clinical Chemistry System	ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. (Expanded platforms compared to predicate)
Method	Photometric (Same as predicate)	Photometric (Same as predicate)
Calibration Stability	7 days (BUN), 2 days (Creatinine), 30 days (Uric Acid)	Same
On-Board Stability	30 days (BUN), 10 days (Creatinine), 30 days (Uric Acid), 25 days (CK)	Same
Sample Type	Serum (per predicate)	Serum and lithium heparin plasma (Candidate device demonstrates equivalence in both)
Sample Volume	3 µL (BUN, Uric Acid), 20 µL (Creatinine), 5 µL (CK)	Same
Reaction Volume	333 µL (BUN), 240 µL (Creatinine), 243 µL (Uric Acid), 170 µL (CK)	Same
Expected Values	Same as predicate	Same
Measuring Range	3-100 mg/dL (BUN), 0.33-25.0 mg/dL (Creatinine), 1.5-16.0 mg/dL (Uric Acid), 11-1350 U/L (CK)	Same
Sample Stability	Same as predicate (storage conditions)	Same
Precision	Low, Mid, High %CV and SD comparable to predicate/clinical needs	In-House Serum/Plasma: Generally <15% CV for low, <5% CV for mid/high. (See pages 6-7, specific values listed). POL: Generally <10% CV for low, <5% CV for mid/high. (See pages 10-13, specific values listed).
Matrix Comparison	Serum vs. Lithium Heparin Plasma: Slope, Intercept, Correlation (R) and Std Error Est. demonstrating equivalence (e.g., R > 0.98, Slope ~1, Intercept ~0)	BUN: R > 0.99, Slope 0.979-1.009, Intercept -0.1 to 0.4. Creatinine: R > 0.99, Slope 1.003-1.050, Intercept -0.077 to 0.005. Uric Acid: R > 0.98, Slope 1.008-1.028, Intercept -0.29 to -0.09. CK: R > 0.99, Slope 0.978-1.006, Intercept -0.5 to 0.1. (See pages 8-9)
Method Comparison (POL)	Comparison to In-House ACE results: Slope, Intercept, Correlation (R) and Std Error Est. demonstrating equivalence to predicate system (e.g., R > 0.98, Slope ~1, Intercept ~0).	BUN: R > 0.99, Slope 0.989-1.039, Intercept -0.1 to 1.4. Creatinine: R > 0.99, Slope 0.977-1.051, Intercept -0.085 to 0.037. Uric Acid: R > 0.99, Slope 0.936-1.034, Intercept 0.02 to 0.58. CK: R > 0.99, Slope 0.962-1.053, Intercept -16.5 to 1.1. (See pages 14-15)
Detection Limits (LoB, LoD, LoQ)	Low values demonstrating capability to measure analytes at clinically relevant low concentrations.	BUN: LoB 1.53, LoD 1.97, LoQ 3.0 mg/dL. Creatinine: LoB 0.14, LoD 0.18, LoQ 0.33 mg/dL. Uric Acid: LoB 1.11, LoD 1.34, LoQ 1.50 mg/dL. CK: LoB 4.68, LoD 8.30, LoQ 11.0 U/L. (See page 16)
Linearity	Wide linear range covering clinical needs, with high correlation.	BUN: Linear to 100.0 mg/dL, R² 0.9991. Creatinine: Linear to 25.0 mg/dL, R² 0.9981. Uric Acid: Linear to 16.0 mg/dL, R² 0.9939. CK: Linear to 1350.0 U/L, R² 0.9975. (See page 16)
Interferences	No significant interference at specified levels of common interferents.	Demonstrated no significant interference from icterus, hemolysis, lipemia/triglycerides, and ascorbic acid at clinically relevant concentrations for all four analytes. (See page 17)

Studies Proving Acceptance Criteria:

The studies are described under "Performance Data" and "Device Comparison with Predicate" sections of the 510(k) summary. These studies aim to demonstrate substantial equivalence to the previously cleared predicate device (Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents, K930104).

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

Test Set (Matrix Comparison: Serum vs. Plasma):
- BUN: 95 pairs (ACE), 96 pairs (Alera), 51 pairs (Axcel)
- Creatinine: 102 pairs (ACE), 102 pairs (Alera), 55 pairs (Axcel)
- Uric Acid: 97 pairs (ACE), 95 pairs (Alera), 55 pairs (Axcel)
- CK: 94 pairs (ACE), 96 pairs (Alera), 55 pairs (Axcel)
- Data Provenance: The document states "In-House Precision" and "In-House Matrix Comparison". This typically implies that the data was generated within the manufacturer's laboratory or a testing facility under their control. The country of origin is not explicitly stated but is implicitly the US, given the 510(k) submission to the FDA. The data is retrospective, as it's being used to characterize reagent performance.
Test Set (POL - Method Comparison):
- BUN: 53-54 samples per POL lab for comparison with In-House ACE.
- Creatinine: 51 samples per POL lab for comparison with In-House ACE.
- Uric Acid: 49 samples per POL lab for comparison with In-House ACE.
- Creatinine Kinase: 48-50 samples per POL lab for comparison with In-House ACE.
- Data Provenance: "POL - Method Comparison" indicates data from Physician Office Laboratories (POLs), likely external to the main testing facility but still considered part of the overall validation. The document refers to "In-House ACE (x) vs. POL 1 ACE (y)", "POL 2 ACE (y)", etc., indicating comparisons against internal reference methods. The data is retrospective.
Test Set (Detection Limits, Linearity, Interferences, Alera Precision): The sample sizes for these specific studies are not explicitly detailed in the provided summary beyond "Low level tested," "Upper level tested," and "number of replicates for precision measurements (i.e. '3.2, 4.0%') implies multiple measurements. These are likely in-house, retrospective studies.

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

This information is not provided in the document. For in vitro diagnostic devices like these reagents, the "ground truth" is typically established by reference methods or validated comparative methods, often run on established clinical chemistry analyzers. The expertise lies in operating these reference instruments and ensuring proper laboratory practices, rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretations (e.g., medical image analysis by radiologists) where discrepancies among readers need to be resolved to establish ground truth. For quantitative IVD reagents, the reference method provides a direct numerical result, not a subjective interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used to assess the effectiveness of an AI system (or any diagnostic aid) for human readers, particularly in medical imaging. The current device is a diagnostic reagent, which directly measures chemical concentrations, not an AI intended to assist human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable in the context of an IVD reagent. The "algorithm" here is the chemical reaction and photometric measurement itself. The performance data presented (precision, linearity, method comparison, etc.) is the standalone performance of the reagent on the specified analyzers, without human interpretive input altering the result.

7. Type of Ground Truth Used

The ground truth for all performance studies (precision, matrix comparison, method comparison, linearity) is established by comparison against a reference method or a substantially equivalent predicate method performed on existing, validated clinical chemistry analyzers (specifically, the predicate ACE Clinical Chemistry System and the candidate ACE, ACE Alera, and ACE Axcel systems themselves acting as the "reference" for their own performance claims, and for method comparisons, the "In-House ACE" results). This is a common and accepted approach for demonstrating substantial equivalence for IVD reagents.

8. Sample Size for the Training Set

This information is not provided and is generally not applicable in the way it is asked for AI/ML devices. These are chemical reagents, not AI/ML algorithms that require "training sets" in the conventional sense of machine learning. The development process would involve formulation, optimization, and internal testing to define assay parameters, which is a different concept than an AI training set.

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

As stated above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable to these chemical reagents. The "ground truth" during their development and optimization would be based on established analytical chemistry principles and performance measurements against known standards or reference materials.

Summary

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.12 3322

510(k) SUMMARY

MAY 2 1 2013

510(k) Owner:	Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006
Contact:	Hkatz@AlfaWassermannUS.comHyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237
Date SummaryPrepared:	May 14, 2013
Device:	Trade Name:	ACE BUN/Urea Reagent
	Classification:	Class 2
	Common/Classification Name:	Urease, Photometric, Urea Nitrogen(21 C.F.R. § 862.1770)Product Code CDN
	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:	ACE Uric Acid Reagent
	Classification:	Class 1, reserved
	Common/Classification Name:	Acid, Uric, Uricase (Colorimetric)(21 C.F.R. § 862.1775)Product Code KNK
	Trade Name:	ACE CK Reagent
	Classification:	Class 2
	Common/Classification Name:	NAD Reduction/NADH Oxidation, CPK OrIsoenzymes(21 C.F.R. § 862.1215)Product Code CGS

な

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PredicateDevices:	Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric AcidReagent, and ACE CK Reagents (K930104)	Indications for Use:	The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains α-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP),nicotinamide adenine dinucleotide and reduced (NADH).
DeviceDescriptions:	In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed in the presence ofurease to yield ammonia and carbon dioxide. The ammonia formed then reacts in thepresence of glutamate dehydrogenase with 2-oxoglutarate and NADH to yield glutamateand NAD. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rateof decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportionalto the urea concentration in the sample.	The ACE BUN/Urea Reagent is intended for the quantitative determination of bloodurea nitrogen (BUN) concentration in serum and lithium heparin plasma using theACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements areused in the diagnosis and treatment of certain renal and metabolic diseases. This test isintended for use in clinical laboratories or physician office laboratories. For in vitrodiagnostic use only.	The ACE Creatinine Reagent consists of two reagent bottles. The Sodium HydroxideReagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picricAcid.
	In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkalinemedium to form a red-orange colored complex, which absorbs strongly at 505 nm. Therate of complex formation, determined by measuring the increase in absorbancebichromatically at 505 nm/573 nm during a fixed time interval, is directly proportionalto the creatinine concentration in the sample.	The ACE Creatinine Reagent is intended for the quantitative determination of creatinineconcentration in serum and lithium heparin plasma using the ACE, ACE Alera, andACE Axcel Clinical Chemistry Systems. Creatinine measurements are used in thediagnosis and treatment of renal diseases, in monitoring renal dialysis, and as acalculation basis for measuring other urine analytes. This test is intended for use inclinical laboratories or physician office laboratories. For in vitro diagnostic use only.	The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase.
	In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase toallantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxidatively coupledichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed byperoxidase, producing a red colored quinoneimine complex, which absorbs strongly at505 nm. The amount of chromogen formed is determined by measuring the increase inabsorbance bichromatically at 505 nm/610 nm, and is directly proportional to the uricacid concentration in the sample.	The ACE Uric Acid Reagent is intended for the quantitative determination of uric acidconcentration in serum and lithium heparin plasma using the ACE, ACE Alera, andACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in thediagnosis and treatment of numerous renal and metabolic disorders, including renalfailure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patientsreceiving cytotoxic drugs. This test is intended for use in clinical laboratories orphysician office laboratories. For in vitro diagnostic use only.	The ACE CK Reagent consists of two reagent bottles. The Buffer Reagent (R1)contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA,NADP and hexokinase. The Substrate Reagent (R2) contains: creatine phosphate, ADP,AMP, diadenosine pentaphosphate, EDTA and glucose-6-phosphate dehydrogenase.
	In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatinephosphate to creatine with the transfer of a phosphate group to adenosine diphosphate(ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose toform D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. Theenzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series ofreactions triggered by serum creatine kinase and ending in the formation of NADPH.NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate ofconversion of NADP+ to NADPH can be determined by monitoring the increase inabsorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ toNADPH is a function of the activity of CK in the sample.	The ACE CK Reagent is intended for the quantitative determination of creatine kinaseactivity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACEAxcel Clinical Chemistry Systems. Measurement of creatine kinase is used in thediagnosis and treatment of myocardial infarction and muscle diseases such asprogressive, Duchenne-type muscular dystrophy. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic use only.

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Device Comparison with Predicate

Comparison of similarities and differences with predicate device .

BUN/Urea	Candidate Device	Predicate DeviceK930104(ACE BUN/Urea)
Intended Use/Indications for Use	The ACE BUN/Urea Reagent is intended for thequantitative determination of blood urea nitrogen(BUN) concentration.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel Clinical ChemistrySystems	ACE ClinicalChemistry System
Method	Photometric	Same
Calibration Stability	7 days	Same
On-Board Stability	30 days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	3 µL	Same
Reaction Volume	333 µL	Same
Expected Values	6 - 20 mg/dL	Same
Measuring Range	3 - 100 mg/dL	Same
Sample Stability	Samples may be stored for 7 days at 4-8°C and for 1year at -20 °C.	Same

ACE BUN/Urea Reagent

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Device Comparison

with Predicate

ACE Creatinine Reagent

Creatinine	Candidate Device	Predicate DeviceK930104(ACE Creatinine)
Intended Use/Indications for Use	The ACE Creatinine Reagent is intended for thequantitative determination of creatinine concentration.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems	ACE ClinicalChemistry System
Method	Photometric	Same
Calibration Stability	2 days	Same
On-Board Stability	10 days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	20 µL	Same
Reaction Volume	240 µL	Same
Expected Values	Female: 0.6-1.1 mg/dLMale: 0.9-1.3 mg/dL	Same
Measuring Range	0.33 - 25.0 mg/dL	Same
Sample Stability	Creatinine is stable for 7 days when refrigerated at 4-8 °C and for 3 months frozen at -20 °C.	Same

ACE Uric Acid Reagent

Uric Acid	Candidate Device	Predicate DeviceK930104(ACE Uric Acid)
Intended Use/Indications for Use	The ACE CK Reagent is intended for the quantitativedetermination of creatine kinase activity.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems	ACE ClinicalChemistry System
Method	Photometric	Same
Calibration Stability	30 Days	Same
On-Board Stability	30 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	3 µL	Same
Reaction Volume	243 µL	Same
Expected Values	Female: 2.6-6.0 mg/dLMale: 3.5-7.2 mg/dL	Same
Measuring Range	1.5 - 16.0 mg/dL	Same
Sample Stability	Separated from cells, uric acid is stable for 3-5 days at4 °C and for 6 months frozen at -20°C.	Same

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ACE CK Reagent
Creatinine Kinase
Candidate Device	Predicate DeviceK930104(ACE CK)
Intended Use/Indications for Use	ACE Magnesium Reagent is intended for thequantitative determination of magnesium.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems	ACE ClinicalChemistry System
Method	Photometric	Same
Calibration Stability	Not Applicable	Same
On-Board Stability	25 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	5 µL	Same
Reaction Volume	170 µL	Same
Expected Values	Female: 26-140 U/LMale: 38-174 U/L	Same
Measuring Range	11 - 1350 U/L
Sample Stability	Serum magnesium is stable for 7 days at 4-8°C and1 year at -20 °C if the serum is separated from theerythrocytes.	Same

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Performance Data:

In-House Precision -Serum vs. Plasma

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems

In-House Precision: Serum vs. Plasma – ACE BUN/Urea Reagent

Precision (SD, %CV)
BUNmg/dL	ACEMean	Within-Run	Total	AleraMean	Within-Run	Total	AxcelMean	Within-Run	Total
SerumLow	5	0.5, 11.1%	0.6, 12.4%	5	0.4, 7.9%	0.6, 13.6%	4	0.4, 8.1%	0.5, 12.1%
SerumMid	46	0.7, 1.4%	0.9, 1.8%	46	0.4, 0.9%	0.7, 1.5%	45	0.6, 1.2%	0.7, 1.5%
SerumHigh	85	2.4, 2.8%	2.7, 3.2%	85	1.4, 1.6%	1.8, 2.1%	85	1.3, 1.5%	1.7, 2.0%
PlasmaLow	4	0.4, 10.7%	0.5, 12.8%	4	0.0, 0.0%	0.0, 0.0%	4	0.3, 6.3%	0.3, 6.3%
PlasmaMid	46	0.4, 0.9%	0.7, 1.5%	45	0.5, 1.1%	0.9, 1.9%	45	0.6, 1.4%	0.6, 1.4%
PlasmaHigh	85	2.9, 3.4%	3.2, 3.8%	85	1.3, 1.5%	1.6, 1.9%	84	1.8, 2.2%	1.9, 2.3%

In-House Precision: Serum vs. Plasma – ACE Creatinine Reagent

Creatininemg/dL	ACEMean	Within-Run	Total	AleraMean	Within-Run	Total	AxcelMean	Within-Run	Total
SerumLow	0.67	0.04, 5.8%	0.06, 8.5%	0.70	0.02, 3.2%	0.04, 5.6%	0.70	0.04, 6.0%	0.06, 8.1%
SerumMid	9.32	0.28, 3.0%	0.28, 3.0%	9.24	0.21, 2.3%	0.22, 2.4%	9.31	0.16, 1.7%	0.19, 2.1%
SerumHigh	18.25	0.13, 0.7%	0.35, 1.9%	17.96	0.18, 1.0%	0.22, 1.2%	17.97	0.14, 0.8%	0.23, 1.3%
PlasmaLow	0.65	0.04, 6.3%	0.06, 9.0%	0.66	0.04, 5.5%	0.05, 7.8%	0.64	0.04, 6.6%	0.06, 9.3%
PlasmaMid	9.47	0.23, 2.5%	0.25, 2.7%	9.41	0.23, 2.5%	0.23, 2.5%	9.42	0.19, 2.0%	0.25, 2.6%
PlasmaHigh	18.38	0.20, 1.1%	0.45, 2.4%	18.04	0.19, 1.0%	0.22, 1.2%	18.13	0.31, 1.7%	0.43, 2.4%

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In-House Precision: Serum vs. Plasma – ACE Uric Acid Reagent

Performance Data:

In-House Precision -Serum vs. Plasma

Precision (SD, %CV)
Uric Acidmg/dL	ACEMean	Within-Run	Total	AleraMean	Within-Run	Total	AxcelMean	Within-Run	Total
SerumLow	4.5	0.1,2.6%	0.2, 4.5%	4.5	0.1,3.0%	0.2. 4.6%	4.5	0.1, 1.5%	0.2.4.4%
SerumMid	9.3	0.1, 1.3%	0.2, 2.5%	9.2	0.1, 0.8%	0.2, 2.6%	9.3	0.1. 0.9%	0.3. 2.8%
SerumHigh	15.0	0.3, 1.8%	0.3, 2.0%	14.8	0.3, 1.9%	0.3, 2.1%	14.9	0.2, 1.1%	0.3, 1.8%
PlasmaLow	4.3	0.2, 3.6%	0.2、5.5%	4.3	0.1,3.3%	0.2, 5.5%	4.3	0.1, 2.8%	0.2, 4.5%
PlasmaMid ·	9.0	0.1, 0.7%	0.2, 1.9%	8.9	0.2, 2.1%	0.2, 2.6%	0.0	0.1, 1.0%	0.2, 2.0%
PlasmaHigh	14.7	0.2, 1.2%	0.2, 1.4%	14.5	0.3, 1:8%	0.3, 1.9%	14.5	0.2, 1.2%	0.2, 1.3%

In-House Precision: Serum vs. Plasma - ACE CK Reagent

CKmg/dL	ACEMean	Within-Run	Total	AleraMean	Within-Run	Total	AxcelMean	Within-Run	Total
SerumLow	79	3.2, 4.0%	3.2, 4.0%	81	3.8, 4.7%	4.1, 5.0%	85	1.5,1.7%	2.3,2.7%
SerumMid	636	7.7, 1.2%	30.9, 4.9%	615	9.4, 1.5%	28.6, 4.6%	682	3.7,0.5%	31.4, 4.6%
SerumHigh	1176	17.4, 1.5%	56.1, 4.8%	1125	7.9, 0.7%	55.5, 4.9%	1255	7.2, 0.6%	58.4, 4.7%
PlasmaLow	61	2.8, 4.6%	3.1, 5.1%	65	1.8, 2.8%	2.8, 4.4%	66	1.8,2.8%	2.1,3.2%
PlasmaMid	619	11.1, 1.8%	25.8, 4.2%	605	8.8, 1.5%	32.4, 5.4%	666	13.0, 2.0%	36.5, 5.5%
PlasmaHigh	1140	16.1, 1.4%	57.1, 5.0%	1111	14.4, 1.3%	51.1,4.6%	1221	11.7, 1.0%	54.7,4.5%

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Performance Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems

In-House Matrix Comparison -Serum vs. Plasma

Data:

In-House Matrix Comparison: Serum vs. Plasma – ACE BUN/Urea Nitrogen Reagent

System	Range	Results - Serum vs. Plasma
ACE95 pairs	3-91 mg/dL	Slope: 0.979Intercept: 0.4Correlation: 0.9980Std. Error Est: 1.2Confidence Interval Slope: 0.966 to 0.992Confidence Interval Intercept: 0.0 to 0.7
ACE Alera96 pairs	3-96 mg/dL	Slope: 1.009Intercept: -0.1Correlation: 0.9976Std. Error Est: 1.4Confidence Interval Slope: 0.995 to 1.023Confidence Interval Intercept: -0.5 to 0.4
ACE Axcel51 pairs	3-100 mg/dL	Slope: 1.007Intercept: 0.3Correlation: 0.9944Std. Error Est: 2.4Confidence Interval Slope: 0.977 to 1.038Confidence Interval Intercept: -0.7 to 1.4

In-House Matrix Comparison: Serum vs. Plasma – ACE Creatinine Reagent

System	Range	Results - Serum vs. Plasma
ACE102 pairs	0.37-22.12 mg/dL	Slope: 1.014Intercept: -0.003Correlation: 0.9974Std. Error Est: 0.279Confidence Interval Slope: 1.000 to 1.029Confidence Interval Intercept: -0.068 to 0.062
ACE Alera102 pairs	0.41-23.15 mg/dL	Slope: 1.050Intercept: -0.077Correlation: 0.9984Std. Error Est: 0.197Confidence Interval Slope: 1.038 to 1.062Confidence Interval Intercept: -0.124 to -0.029
ACE Axcel55 pairs	0.37-23.45 mg/dL	Slope: 1.003Intercept: 0.005Correlation: 0.9993Std. Error Est: 0.197Confidence Interval Slope: 0.993 to 1.013Confidence Interval Intercept: -0.058 to 0.069

{9}------------------------------------------------

Performance Data:

In-House Matrix Comparison -Serum vs. Plasma

In-House Matrix Comparison: Serum vs. Plasma – ACE Uric Acid Reagent

System	Range	Results - Serum vs. Plasma
ACE97 pairs	2.5-14.0 mg/dL	Slope: 1.008Intercept: -0.14Correlation: 0.9906Std. Error Est: 0.35Confidence Interval Slope: 0.980 to 1.036Confidence Interval Intercept: -0.34 to 0.06
ACE Alera95 pairs	2.5-14.4 mg/dL	Slope: 1.028Intercept: -0.29Correlation: 0.9836Std. Error Est: 0.48Confidence Interval. Slope: 0.989 to 1.066Confidence Interval Intercept: -0.57 to -0.01
ACE Axcel55 pairs	1.8-15.6 mg/dL	Slope: 1.025Intercept: -0.09Correlation: 0.9879Std. Error Est: 0.42Confidence Interval Slope: 0.981 to 1.069Confidence Interval Intercept: -0.39 to 0.21

In-House Matrix Comparison: Serum vs. Plasma - ACE CK Reagent

System	Range	Results - Serum vs. Plasma
ACE94 pairs	11-1234 U/L	Slope: 0.997Intercept: -0.5Correlation: 0.9965Std. Error Est: 23.5Confidence Interval Slope: 0.980 to 1.014Confidence Interval Intercept: -6.3 to 5.2
ACE Alera96 pairs	14-1211 U/L	Slope: 0.978Intercept: 0.1Correlation: 0.9960Std. Error Est: 22.1Confidence Interval Slope: 0.960 to 0.996Confidence Interval Intercept: -5.2 to 5.5
ACE Axcel55 pairs	17-1315 U/L	Slope: 1.006Intercept: -0.50Correlation: 0.9990Std. Error Est: 13.24Confidence Interval Slope: 0.993 to 1.019Confidence Interval Intercept: -4.74 to 3.74

{10}------------------------------------------------

POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

Data: Precision - ·

Performance

POL

(Note: Refer to previously cleared submission K113389 for ACE Axcel POL data)

BUN/Urea		ACE Result			ACE Alera Result
		mg/dL SD, %CV			mg/dL SD, %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	8	0.00 SD0.0%	0.30 SD4.0%	8	0.40 SD5.5%	0.60 SD7.7%
POL 1	1	8	0.30 SD3.9%	0.30 SD3.9%	9	0.40 SD4.5%	0.50 SD6.2%
POL 2	1	8	0.40 SD4.4%	0.50 SD5.6%	8	0.20 SD2.8%	0.40 SD4.9%
POL 3	1	8	0.30 SD3.9%	0.30 SD3.9%	9	0.30 SD3.6%	0.70 SD8.3%
In-House	2	41	1.90 SD4.7%	2.00 SD5.0%	42	1.30 SD3.2%	1.60 SD3.9%
POL 1	2	43	0.40 SD1.0%	0.80 SD1.9%	43	1.40 SD3.4%	1.70 SD4.0%
POL 2	2	42	0.30 SD0.7%	1.40 SD3.3%	41	1.10 SD2.7%	1.80 SD4.4%
POL 3	2	42	1.00 SD2.4%	1.10 SD2.6%	44	0.70 SD1.7%	1.40 SD3.3%
In-House	3	74	1.10 SD1.5%	2.40 SD3.2%	75	0.40 SD0.5%	2.00 SD2.6%
POL 1	3	75	1.30 SD1.8%	1.30 SD1.8%	76	1.20 SD1.6%	1.80 SD2.4%
POL 2	3	73	1.30 SD1.8%	2.30 SD3.1%	74	1.70 SD2.3%	2.80 SD3.7%
POL 3	3	76	1.20 SD1.6%	1.40 SD1.9%	76	1.10 SD1.4%	2.20 SD2.9%

{11}------------------------------------------------

Performance Data at POL:

Precision -

· ·

POL

POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

Creatinine		ACE Resultmg/dL SD, %CV			ACE Alera Resultmg/dL SD, %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	0.58	0.04 SD6.4%	0.05 SD8.8%	0.58	0.02 SD3.2%	0.03 SD5.3%
POL 1	1	0.51	0.03 SD5.6%	0.04 SD8.4%	0.53	0.03 SD6.0%	0.05 SD9.3%
POL 2	1	0.54	0.04 SD6.9%	0.05 SD9.8%	0.56	0.02 SD4.2%	0.03 SD4.4%
POL 3	1	0.53	0.04 SD6.6%	0.04 SD7.5%	0.55	0.02 SD4.3%	0.04 SD6.3%
In-House	2	8.29	0.09 SD1.0%	0.32 SD3.9%	8.08	0.11 SD1.3%	0.28 SD3.5%
POL 1	2	7.97	0.08 SD1.0%	0.20 SD2.5%	7.84	0.08 SD1.1%	0.15 SD1.9%
POL 2	2	7.60	0.11 SD1.4%	0.43 SD5.7%	8.21	0.14 SD1.7%	0.23 SD2.8%
POL 3	2	7.89	0.11 SD1.4%	0.13 SD1.7%	7.98	0.09 SD1.1%	0.23 SD2.9%
In-House	3	12.92	0.18 SD1.4%	0.46 SD3.5%	12.65	0.07 SD0.5%	0.42 SD3.3%
POL 1	3	12.42	0.23 SD1.9%	0.37SD3.0%	12.32	0.10 SD0.9%	0.42 SD3.4%
POL 2	3	11.67	0.22 SD1.9%	0.53 SD4.5%	12.81	0.31 SD2.4%	0.50 SD3.9%
POL 3	3	12.28	0.17 SD1.4%	0.18 SD1.5%	12.27	0.12 SD1.0%	0.44 SD3.6%

{12}------------------------------------------------

POL – Precision for ACE and ACE Alera Clinical Chemistry Systems

Performance Data at POL:

Precision -POL

Uric Acid			ACE Resultmg/dL SD, %CV			ACE Alera Resultmg/dL SD, %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	2.9	0.19 SD6.5%	0.19 SD6.5%	2.9	0.10 SD3.5%	0.13 SD4.5%
POL 1	1	3.0	0.05 SD1.7%	0.09 SD3.1%	3.0	0.15 SD5.2%	0.16 SD5.3%
POL 2	1	2.8	0.10 SD3.5%	0.11 SD4.0%	2.9	0.09 SD3.1%	0.10 SD3.6%
POL 3	1	2.9	0.06 SD2.2%	0.14 SD5.0%	3.2	0.05 SD1.6%	0.09 SD2.9%
In-House	2	8.0	0.13 SD1.6%	0.15 SD1.9%	8.0	0.05 SD0.7%	0.17 SD2.1%
POL 1	2	7.7	0.05 SD0.6%	0.11 SD1.4%	7.6	0.13 SD1.7%	0.21 SD2.8%
POL 2	2	7.5	0.13 SD1.7%	0.16 SD2.2%	7.5	0.08 SD1.0%	0.13 SD1.8%
POL 3	2	7.9	0.10 SD1.2%	0.13 SD1.7%	7.9	0.07 SD0.9%	0.25 SD3.1%
In-House	3	12.5	0.35 SD2.8%	0.38 SD3.0%	12.7	0.18 SD1.4%	0.22 SD1.7%
POL 1	3	12.0	0.13 SD1.1%	0.28 SD2.4%	11.9	0.14 SD1.2%	0.26 SD2.2%
POL 2	3	11.8	0.29 SD2.5%	0.32 SD2.7%	11.6	0.27 SD2.4%	0.27 SD2.4%
POL 3	3	12.3	0.11 SD0.9%	0.12 SD1.0%	12.2	0.15 SD1.2%	0.35 SD2.9%

{13}------------------------------------------------

Performance Data at POL:

Data at T.O.E.

Precision -POL

POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

CK			ACE Resultmg/dL SD, %CV			ACE Alera Resultmg/dL SD, %CV
Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
In-House	1	77	3.20 SD4.2%	4.00 SD5.2%	75	2.50 SD3.3%	3.30 SD4.4%
POL 1	1	70	1.40 SD2.0%	2.90 SD4.1%	73	1.40 SD1.9%	2.60 SD3.6%
POL 2	1	69	1.90 SD2.7%	3.00 SD4.4%	70	2.20 SD3.2%	3.50 SD5.0%
POL 3	1	79	2.60 SD3.2%	2.70 SD3.4%	70	2.10 SD3.0%	4.10 SD5.9%
In-House	2	521	6.70 SD1.3%	7.20 SD1.4%	516	8.00 SD1.5%	8.10 SD1.6%
POL 1	2	568	4.90 SD0.9%	6.90 SD1.2%	567	10.00 SD1.8%	14.00 SD2.5%
POL 2	2	526	3.90 SD0.7%	9.20 SD1.8%	514	6.50 SD1.3%	8.80 SD1.7%
POL 3	2	540	4.00 SD0.7%	4.30 SD0.8%	559	6.90 SD1.2%	14.10 SD2.5%
In-House	3	907	10.90SD1.2%	14.60SD1.6%	905	9.50 SD1.1%	14.00 SD1.6%
POL 1	3	967	22.00SD2.3%	22.70SD2.3%	995	7.60 SD0.8%	14.40 SD1.4%
POL 2	3	929	18.60SD2.0%	18.90SD2.0%	899	11.40SD1.3%	11.60SD1.3%
POL 3	3	950	7.80 SD0.8%	9.90 SD1.0%	977	13.00SD1.3%	19.60 SD2.0%

. . . . .

{14}------------------------------------------------

PerformanceData:		POL – Method Comparison for ACE Clinical Chemistry System
MethodComparison -POL on ACE	Reagent	Statistic	In-House ACE (x)vs.POL 1 ACE (y)	In-House ACE (x)vs.POL 2 ACE (y)	In-House ACE (x)vs.POL 3 ACE (y)
	BUN	n	53	54	54
		Range	3 to 88	3 to 88	3 to 88
		Regression	$y = 1.034x - 0.1$	$y = 1.025x + 0.0$	$y = 1.031x + 0.0$
		Correlation	0.9989	0.9985	0.9990
		Std. Error Est.	0.9	1.1	0.9
		CI Slope	1.020 to 1.047	1.010 to 1.040	1.018 to 1.044
		CI Intercept	-0.5 to 0.2	-0.4 to 0.5	-0.3 to 0.4
	Creatinine	n	51	51	51
		Range	0.34 to 22.57	0.34 to 22.57	0.34 to 22.57
		Regression	$y = 1.032x - 0.010$	$y = 1.010x - 0.046$	$y = 0.986x - 0.017$
		Correlation	0.9994	0.9997	0.9999
		Std. Error Est.	0.148	0.100	0.060
		CI Slope	1.022 to 1.042	1.003 to 1.016	0.982 to 0.990
		CI Intercept	-0.057 to 0.037	-0.078 to -0.014	-0.036 to 0.002
	Uric Acid	n	49	49	49
		Range	1.7 to 14.5	1.7 to 14.5	1.7 to 14.5
		Regression	$y = 0.988x + 0.23$	$y = 1.018x - 0.06$	$y = 1.009x + 0.03$
		Correlation	0.9939	0.9957	0.9969
		Std. Error Est.	0.27	0.23	0.19
		CI Slope	0.956 to 1.020	0.991 to 1.046	0.985 to 1.032
		CI Intercept	0.01 to 0.45	-0.25 to 0.13	-0.13 to 0.19
	Creatininekinase	n	50	48	49
		Range	11 to 1204	11 to 1204	11 to 1204
		Regression	$y = 1.010x - 7.7$	$y = 0.989x - 8.0$	$y = 0.986x - 1.8$
		Correlation	0.9976	0.9987	0.9996
		Std. Error Est.	19.2	13.9	7.7
		CI Slope	0.990 to 1.031	0.974 to 1.004	0.978 to 0.995
		CI Intercept	-14.7 to -0.7	-13.2 to -2.8	-4.6 to 1.1

: 上一篇:

. .

11 - 11

{15}------------------------------------------------

PerformanceData at POL:MethodComparison -POL on ACEAlera	Statistic	In-House ACE (x)vs.POL 1 Alera (y)	In-House ACE (x)vs.POL 2 Alera (y)	In-House ACE (x)VS.POL 3 Alera (y)
BUN	n	53	53	53
	Range	3 to 88	3 to 88	3 to 88
	Regression	$y = 1.039x + 0.3$	$y = 1.011x + 0.2$	$y = 1.019x + 1.4$
	Correlation	0.9987	0.9990	0.9972
	Std. Error Est.	0.9	0.8	1.4
	CI Slope	1.024 to 1.053	0.998 to 1.023	0.997 to 1.040
	CI Intercept	-0.1 to 0.6	-0.1 to 0.6	0.4 to 1.6
Creatinine	n	51	51	51
	Range	0.34 to 22.57	0.34 to 22.57	0.34 to 22.57
	Regression	$y = 0.987x - 0.012$	$y = 1.041x - 0.038$	$y = 1.000x - 0.033$
	Correlation	0.9993	0.9994	0.9986
	Std. Error Est.	0.149	0.149	0.220
	CI Slope	0.977 to 0.998	1.031 to 1.051	0.985 to 1.015
	CI Intercept	-0.059 to 0.036	-0.085 to 0.010	-0.083 to 0.057
Uric acid	n	49	49	49
	Range	1.7 to 14.5	1.7 to 14.5	1.7 to 14.0
	Regression	$y = 0.967x + 0.37$	$y = 0.964x + 0.21$	$y = 0.994x + 0.29$
	Correlation	0.9941	0.9951	0.9909
	Std. Error Est.	0.26	0.23	0.33
	CI Slope	0.936 to 0.998	0.936 to 0.992	0.955 to 1.034
	CI Intercept	0.16 to 0.58	0.02 to 0.40	0.02 to 0.56
CreatinineKinase	n	50	49	50
	Range	11 to 1204	11 to 1204	11 to 1204
	Regression	$y = 1.043x - 6.4$	$y = 0.971x - 2.3$	$y = 0.983x - 8.7$
	Correlation	0.9994	0.9995	0.9968
	Std. Error Est.	9.8	7.5	21.5
	CI Slope	1.032 to 1.053	0.962 to 0.980	0.960 to 1.006
	CI Intercept	-9.9 to -2.8	-5.1 to 0.5	-16.5 to -0.9

and the comments of the comments of the comments of the comments of

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{16}------------------------------------------------

Performance Data:

. - .. ·

ACE Alera

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry Systems

Detection Limits - ACE Alera Clinical Chemistry System

ACE Alera	BUN(mg/dL)	Creatinine(mg/dL)	Uric Acid(mg/dL)	CK(U/L)
LoB	1.53	0.14	1.11	4.68
LoD	1.97	0.18	1.34	8.30
LoQ (claimed)	3.0	0.33	1.50	11.0

Linearity - ACE Alera Clinical Chemistry System

ACEReagents	Lowleveltested	Upper leveltested	Linear to:	Linear RegressionEquation	CorrelationCoefficientsR^2
BUN(mg/dL)	0.7	108.7	100.0	$y=1.011x + 0.1$	0.9991
Creatinine(mg/dL)	0.2	32.4	25.0	$y=1.002x + 0.06$	0.9981
Uric Acid(mg/dL)	1.1	17.3	16.0	$y=0.994x - 0.10$	0.9939
CK(U/L)	10.0	1416.7	1350.0	$y=1.053x - 2.6$	0.9975

{17}------------------------------------------------

Performance

Data:

Interferences - ACE Alera Clinical Chemistry System

ACE Alera

ACEAlera	Icterus	Hemolysis	Lipemia(Intralipid)/Triglycerides	Ascorbic Acid
BUN	No significantinterference at orbelow 70 mg/dL	No significantinterference at orbelow 500 mg/dL	No significantinterference at orbelow 2080 mg/dLTriglycerides	No significantinterference at orbelow 6 mg/dL
Creatinine	No significantinterference at orbelow 6.0 mg/dL	No significantinterference at orbelow 1000 mg/dL	No significantinterference at orbelow 2080 mg/dLTriglycerides	. No significantinterference at orbelow 6 mg/dL
UA	No significantinterference at orbelow 16.9 mg/dL	No significantinterference at orbelow 125 mg/dL	No significantinterference at orbelow 893 mg/dLTriglycerides	No significantinterference at orbelow 1.313mg/dL
CK	No significantinterference at orbelow 30 mg/dL	No significantinterference at orbelow 125 mg/dL	No significantinterference at orbelow 2372 mg/dLTriglycerides	No significantinterference at orbelow 6 mg/dL

{18}------------------------------------------------

Precision - ACE Alera Clinical Chemistry System

Performance Data:

ACE Alera

on ACE Alera		Mean	Precision (SD, %CV)
			Within-Run	Total
BUNmg/dL	Low	15	0.3, 2.1%	0.5, 3.1%
BUNmg/dL	Mid	42	0.7, 1.7%	1.3, 3.0%
BUNmg/dL	High	74	1.5, 2.0%	2.3, 3.2%
Creatininemg/dL	Low	0.9	0.03, 3.9%	0.08, 9.8%
Creatininemg/dL	Mid	1.7	0.04, 2.4%	0.12, 7.5%
Creatininemg/dL	High	5.4	0.13, 2.5%	0.22, 4.1%
Uric Acidmg/dL	Low	3.5	0.10, 3.0%	0.18, 5.2%
Uric Acidmg/dL	Mid	6.0	0.14, 2.3%	0.25, 4.1%
Uric Acidmg/dL	High	11.6	0.32, 2.8%	0.55, 4.7%
CKU/L	Low	128	2.2, 1.7%	3.8, 3.0%
CKU/L	Mid	378	6.8, 1.8%	11.5, 3.0%
CKU/L	High	865	8.5, 1.0%	16.2, 1.9%

{19}------------------------------------------------

Method Comparison - ACE Alera Clinical Chemistry System
	BUN(mg/dL)	Creatinine(mg/dL)	Uric Acid(mg/dL)	CK(U/L)
n	53	51	50	49
Range	3 - 88	0.34 - 22.57	1.7 - 14.5	11 - 1204
Slope	1.000	1.016	0.992	0.991
Intercept	0.1	-0.002	0.05	-1.3
CorrelationCoefficient	0.9988	0.9997	0.9978	0.9999
Std. Error	0.9	0.111	0.17	-1.3
CI Slope	0.986 to 1.014	1.008 to 1.023	0.973 to 1.010	0.987 to 0.995
CI Intercept	-0.3 to 0.4	-0.038 to 0.034	-0.09 to 0.18	-2.6 to 0.0

and the comments of the comments of

{20}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/20/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The symbol is rendered in black, contrasting with the white background.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2013

Alfa Wassermann Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006

Re: K123322

Trade/Device Name: ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, ACE CK Reagent

Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: II Product Code: CDN, CGX, KNK, CGS Dated: March 07, 2013 Received: March 20. 2013

Dear Dr. Katz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical, Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{21}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson - S for

Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{22}------------------------------------------------

Indications for Use

510(k) Number (if known): K123322

Device Name: ACE BUN/Urea Reagent

Indications for Use:

Device Name: ACE Creatinine Reagent

Indications for Use:

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 and Radiological Health (OIR)

YungWDChan-S

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

510(k) K123322

Page 1 of 2

{23}------------------------------------------------

Indications for Use

510(k) Number (if known): K123322

Device Name: ACE Uric Acid Reagent

Indications for Use: The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE CK 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)

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Concurrence of CDRH, Office of In Vitro Diagnostic and Radiological Health (OIR)

YungWDChan-S

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

510(k) K123322

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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.