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K Number
K123322
Device Name
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
Manufacturer
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
Date Cleared
2013-05-21

(207 days)

Product Code
CDNCGSCGXKNK
Regulation Number
862.1770
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K930104

K930104

No
The document describes in vitro diagnostic reagents and their use on clinical chemistry systems. The device description focuses on the chemical reactions and photometric measurements used to determine analyte concentrations. There is no mention of AI or ML in the intended use, device description, or performance studies.

No.
Explanation: The device is intended for in vitro diagnostic use to measure various analytes in blood and plasma for the diagnosis and treatment of diseases, not for therapy or treatment itself.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the BUN, Creatinine, Uric Acid, and CK measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases," "diagnosis and treatment of renal diseases," "diagnosis and treatment of numerous renal and metabolic disorders," and "diagnosis and treatment of myocardial infarction and muscle diseases," respectively. This indicates a diagnostic purpose. The phrase "For in vitro diagnostic use only" further confirms its diagnostic classification.

No

The device description clearly details chemical reactions and the measurement of absorbance, indicating a physical reagent and a clinical chemistry system (hardware) are integral to the device's function.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states that the reagents are "intended for the quantitative determination of [analyte] concentration in serum and lithium heparin plasma" and are used in the "diagnosis and treatment of certain renal and metabolic diseases" or other conditions. This clearly indicates that the reagents are used to test samples taken from the human body to provide information for medical diagnosis.
  • For in vitro diagnostic use only: Each reagent's intended use section explicitly states "For in vitro diagnostic use only." This is a direct declaration that the product is an IVD.
  • Intended User / Care Setting: The intended users are "clinical laboratories or physician office laboratories," which are typical settings for performing in vitro diagnostic tests.
  • Device Description: The description details the chemical reactions that occur when the reagents are combined with a sample, which is the core principle of an in vitro diagnostic test.
  • Performance Studies: The document describes performance studies that evaluate the accuracy and reliability of the reagents when used to test samples, which is a requirement for IVD devices.
  • Predicate Device(s): The mention of predicate devices with K numbers (K930104) indicates that these reagents have gone through a regulatory process, likely 510(k) clearance, which is applicable to IVD devices.

All of these points strongly support the classification of these reagents as In Vitro Diagnostic devices.

N/A

Intended Use / Indications for Use

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.

Product codes

CDN, CGX, KNK, CGS

Device Description

ACE BUN/Urea Reagent: 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. The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains alpha-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and reduced (NADH).

ACE Creatinine Reagent: 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. The ACE Creatinine Reagent consists of two reagent bottles. The Sodium Hydroxide Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric Acid.

ACE Uric Acid Reagent: 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. The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase.

ACE CK Reagent: 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. 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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In-House Precision - Serum vs. Plasma (ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems):

  • ACE BUN/Urea Reagent: Precision data (SD, %CV) for serum and plasma samples at low, mid, and high concentrations across the three systems. For example, on ACE, serum low had a mean of 5 mg/dL with a total precision of 0.6 SD, 12.4% CV.
  • ACE Creatinine Reagent: Precision data (SD, %CV) for serum and plasma samples at low, mid, and high concentrations across the three systems. For example, on ACE, serum low had a mean of 0.67 mg/dL with a total precision of 0.06 SD, 8.5% CV.
  • ACE Uric Acid Reagent: Precision data (SD, %CV) for serum and plasma samples at low, mid, and high concentrations across the three systems. For example, on ACE, serum low had a mean of 4.5 mg/dL with a total precision of 0.2 SD, 4.5% CV.
  • ACE CK Reagent: Precision data (SD, %CV) for serum and plasma samples at low, mid, and high concentrations across the three systems. For example, on ACE, serum low had a mean of 79 U/L with a total precision of 3.2 SD, 4.0% CV.

In-House Matrix Comparison - Serum vs. Plasma (ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems):

  • ACE BUN/Urea Nitrogen Reagent: Comparisons for serum vs. plasma across the systems. For example, on ACE (95 pairs, 3-91 mg/dL), Slope: 0.979, Intercept: 0.4, Correlation: 0.9980.
  • ACE Creatinine Reagent: Comparisons for serum vs. plasma across the systems. For example, on ACE (102 pairs, 0.37-22.12 mg/dL), Slope: 1.014, Intercept: -0.003, Correlation: 0.9974.
  • ACE Uric Acid Reagent: Comparisons for serum vs. plasma across the systems. For example, on ACE (97 pairs, 2.5-14.0 mg/dL), Slope: 1.008, Intercept: -0.14, Correlation: 0.9906.
  • ACE CK Reagent: Comparisons for serum vs. plasma across the systems. For example, on ACE (94 pairs, 11-1234 U/L), Slope: 0.997, Intercept: -0.5, Correlation: 0.9965.

POL - Precision (ACE and ACE Alera Clinical Chemistry Systems):

  • BUN/Urea: Precision data (SD, %CV) for 3 samples across In-House and 3 POL labs for ACE and ACE Alera.
  • Creatinine: Precision data (SD, %CV) for 3 samples across In-House and 3 POL labs for ACE and ACE Alera.
  • Uric Acid: Precision data (SD, %CV) for 3 samples across In-House and 3 POL labs for ACE and ACE Alera.
  • CK: Precision data (SD, %CV) for 3 samples across In-House and 3 POL labs for ACE and ACE Alera.

Method Comparison - POL on ACE Clinical Chemistry System:

  • BUN: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 ACE results (n=53 or 54, Range 3 to 88). For example, POL 1: y = 1.034x - 0.1, Correlation: 0.9989.
  • Creatinine: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 ACE results (n=51, Range 0.34 to 22.57). For example, POL 1: y = 1.032x - 0.010, Correlation: 0.9994.
  • Uric Acid: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 ACE results (n=49, Range 1.7 to 14.5). For example, POL 1: y = 0.988x + 0.23, Correlation: 0.9939.
  • Creatinine Kinase: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 ACE results (n=48 or 50, Range 11 to 1204). For example, POL 1: y = 1.010x - 7.7, Correlation: 0.9976.

Method Comparison - POL on ACE Alera Clinical Chemistry System:

  • BUN: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 Alera results (n=53, Range 3 to 88). For example, POL 1: y = 1.039x + 0.3, Correlation: 0.9987.
  • Creatinine: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 Alera results (n=51, Range 0.34 to 22.57). For example, POL 1: y = 0.987x - 0.012, Correlation: 0.9993.
  • Uric acid: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 Alera results (n=49, Range 1.7 to 14.5 or 14.0). For example, POL 1: y = 0.967x + 0.37, Correlation: 0.9941.
  • Creatinine Kinase: Regression and correlation results comparing In-House ACE to POL 1, 2, and 3 Alera results (n=49 or 50, Range 11 to 1204). For example, POL 1: y = 1.043x - 6.4, Correlation: 0.9994.

Detection Limits - ACE Alera Clinical Chemistry System: LoB, LoD, and LoQ values provided for BUN, Creatinine, Uric Acid, and CK.
Linearity - ACE Alera Clinical Chemistry System: Linear range, regression equation (y=mx+b), and correlation coefficients (R^2) for BUN, Creatinine, Uric Acid, and CK.
Interferences - ACE Alera Clinical Chemistry System: Evaluation of significant interference from Icterus, Hemolysis, Lipemia (Intralipid)/Triglycerides, and Ascorbic Acid for BUN, Creatinine, UA, and CK.
Precision on ACE Alera: Precision data (SD, %CV) for BUN, Creatinine, Uric Acid, and CK at low, mid, and high concentrations, including Within-Run and Total precision.
Method Comparison - ACE Alera Clinical Chemistry System: Regression and correlation results for BUN, Creatinine, Uric Acid, and CK (n=49 to 53, ranges provided).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Precision: Standard Deviation (SD) and Coefficient of Variation (%CV) reported for within-run and total precision across various concentration levels.
  • Correlation: Pearson correlation coefficient (R or R^2) reported for matrix and method comparisons.
  • Slope and Intercept: Reported for linear regression analyses in matrix and method comparisons.
  • Std. Error Est.: Standard Error of Estimate reported for regression analyses.
  • Confidence Interval (CI): Confidence intervals for Slope and Intercept reported for regression analyses.
  • Detection Limits: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ).

Predicate Device(s)

Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents (K930104)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

.12 3322

510(k) SUMMARY

MAY 2 1 2013

1

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | |
|---------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--|
| Contact: | Hkatz@AlfaWassermannUS.com
Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | | |
| Date Summary
Prepared: | 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 Or
Isoenzymes
(21 C.F.R. § 862.1215)
Product Code CGS | |

な

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| Predicate
Devices: | Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid
Reagent, and ACE CK Reagents (K930104) | Intended Use: | Indications for Use: | Technological
Characteristics: | 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). |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Descriptions: | 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. | | 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 consists of two reagent bottles. The Sodium Hydroxide
Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric
Acid. |
| | 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. | | 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 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 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. | | 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 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 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. | | 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. | | |

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Device Comparison with Predicate

Comparison of similarities and differences with predicate device .

| BUN/Urea | Candidate Device | Predicate Device
K930104
(ACE BUN/Urea) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use/
Indications for Use | The ACE BUN/Urea Reagent is intended for the
quantitative determination of blood urea nitrogen
(BUN) concentration. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry
Systems | ACE Clinical
Chemistry 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 1
year at -20 °C. | Same |

ACE BUN/Urea Reagent

4

Device Comparison

with Predicate

ACE Creatinine Reagent

| Creatinine | Candidate Device | Predicate Device
K930104
(ACE Creatinine) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Use/
Indications for Use | The ACE Creatinine Reagent is intended for the
quantitative determination of creatinine concentration. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical
Chemistry Systems | ACE Clinical
Chemistry 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/dL
Male: 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 Device
K930104
(ACE Uric Acid) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use/
Indications for Use | The ACE CK Reagent is intended for the quantitative
determination of creatine kinase activity. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical
Chemistry Systems | ACE Clinical
Chemistry 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/dL
Male: 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 at
4 °C and for 6 months frozen at -20°C. | Same |

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| Device
Comparison

with PredicateACE CK Reagent
Creatinine Kinase
Candidate DevicePredicate Device
K930104
(ACE CK)
Intended Use/
Indications for UseACE Magnesium Reagent is intended for the
quantitative determination of magnesium.Same
PlatformsACE, ACE Alera®, and ACE Axcel Clinical
Chemistry SystemsACE Clinical
Chemistry System
MethodPhotometricSame
Calibration StabilityNot ApplicableSame
On-Board Stability25 DaysSame
Sample TypeSerum and lithium heparin plasmaSerum
Sample Volume5 µLSame
Reaction Volume170 µLSame
Expected ValuesFemale: 26-140 U/L
Male: 38-174 U/LSame
Measuring Range11 - 1350 U/L
Sample StabilitySerum magnesium is stable for 7 days at 4-8°C and
1 year at -20 °C if the serum is separated from the
erythrocytes.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)
BUN
mg/dLACE
MeanWithin-
RunTotalAlera
MeanWithin
-RunTotalAxcel
MeanWithin-
RunTotal
Serum
Low50.5, 11.1%0.6, 12.4%50.4, 7.9%0.6, 13.6%40.4, 8.1%0.5, 12.1%
Serum
Mid460.7, 1.4%0.9, 1.8%460.4, 0.9%0.7, 1.5%450.6, 1.2%0.7, 1.5%
Serum
High852.4, 2.8%2.7, 3.2%851.4, 1.6%1.8, 2.1%851.3, 1.5%1.7, 2.0%
Plasma
Low40.4, 10.7%0.5, 12.8%40.0, 0.0%0.0, 0.0%40.3, 6.3%0.3, 6.3%
Plasma
Mid460.4, 0.9%0.7, 1.5%450.5, 1.1%0.9, 1.9%450.6, 1.4%0.6, 1.4%
Plasma
High852.9, 3.4%3.2, 3.8%851.3, 1.5%1.6, 1.9%841.8, 2.2%1.9, 2.3%

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

| Creatinine
mg/dL | ACE
Mean | Within-
Run | Total | Alera
Mean | Within-
Run | Total | Axcel
Mean | Within-
Run | Total |
|---------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|
| Serum
Low | 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% |
| Serum
Mid | 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% |
| Serum
High | 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% |
| Plasma
Low | 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% |
| Plasma
Mid | 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% |
| Plasma
High | 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% |

7

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

Performance Data:

In-House Precision -Serum vs. Plasma

Precision (SD, %CV)
Uric Acid
mg/dLACE
MeanWithin-
RunTotalAlera
MeanWithin-
RunTotalAxcel
MeanWithin-
RunTotal
Serum
Low4.50.1,2.6%0.2, 4.5%4.50.1,3.0%0.2. 4.6%4.50.1, 1.5%0.2.4.4%
Serum
Mid9.30.1, 1.3%0.2, 2.5%9.20.1, 0.8%0.2, 2.6%9.30.1. 0.9%0.3. 2.8%
Serum
High15.00.3, 1.8%0.3, 2.0%14.80.3, 1.9%0.3, 2.1%14.90.2, 1.1%0.3, 1.8%
Plasma
Low4.30.2, 3.6%0.2、5.5%4.30.1,3.3%0.2, 5.5%4.30.1, 2.8%0.2, 4.5%
Plasma
Mid ·9.00.1, 0.7%0.2, 1.9%8.90.2, 2.1%0.2, 2.6%0.00.1, 1.0%0.2, 2.0%
Plasma
High14.70.2, 1.2%0.2, 1.4%14.50.3, 1:8%0.3, 1.9%14.50.2, 1.2%0.2, 1.3%

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

| CK
mg/dL | ACE
Mean | Within-
Run | Total | Alera
Mean | Within-
Run | Total | Axcel
Mean | Within
-Run | Total |
|----------------|-------------|----------------|------------|---------------|----------------|---------------|---------------|----------------|---------------|
| Serum
Low | 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% |
| Serum
Mid | 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% |
| Serum
High | 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% |
| Plasma
Low | 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% |
| Plasma
Mid | 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% |
| Plasma
High | 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% |

8

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

.

SystemRangeResults - Serum vs. Plasma
ACE
95 pairs3-91 mg/dLSlope: 0.979
Intercept: 0.4
Correlation: 0.9980
Std. Error Est: 1.2
Confidence Interval Slope: 0.966 to 0.992
Confidence Interval Intercept: 0.0 to 0.7
ACE Alera
96 pairs3-96 mg/dLSlope: 1.009
Intercept: -0.1
Correlation: 0.9976
Std. Error Est: 1.4
Confidence Interval Slope: 0.995 to 1.023
Confidence Interval Intercept: -0.5 to 0.4
ACE Axcel
51 pairs3-100 mg/dLSlope: 1.007
Intercept: 0.3
Correlation: 0.9944
Std. Error Est: 2.4
Confidence Interval Slope: 0.977 to 1.038
Confidence Interval Intercept: -0.7 to 1.4

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

SystemRangeResults - Serum vs. Plasma
ACE
102 pairs0.37-22.12 mg/dLSlope: 1.014
Intercept: -0.003
Correlation: 0.9974
Std. Error Est: 0.279
Confidence Interval Slope: 1.000 to 1.029
Confidence Interval Intercept: -0.068 to 0.062
ACE Alera
102 pairs0.41-23.15 mg/dLSlope: 1.050
Intercept: -0.077
Correlation: 0.9984
Std. Error Est: 0.197
Confidence Interval Slope: 1.038 to 1.062
Confidence Interval Intercept: -0.124 to -0.029
ACE Axcel
55 pairs0.37-23.45 mg/dLSlope: 1.003
Intercept: 0.005
Correlation: 0.9993
Std. Error Est: 0.197
Confidence Interval Slope: 0.993 to 1.013
Confidence 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

SystemRangeResults - Serum vs. Plasma
ACE
97 pairs2.5-14.0 mg/dLSlope: 1.008
Intercept: -0.14
Correlation: 0.9906
Std. Error Est: 0.35
Confidence Interval Slope: 0.980 to 1.036
Confidence Interval Intercept: -0.34 to 0.06
ACE Alera
95 pairs2.5-14.4 mg/dLSlope: 1.028
Intercept: -0.29
Correlation: 0.9836
Std. Error Est: 0.48
Confidence Interval. Slope: 0.989 to 1.066
Confidence Interval Intercept: -0.57 to -0.01
ACE Axcel
55 pairs1.8-15.6 mg/dLSlope: 1.025
Intercept: -0.09
Correlation: 0.9879
Std. Error Est: 0.42
Confidence Interval Slope: 0.981 to 1.069
Confidence Interval Intercept: -0.39 to 0.21

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

SystemRangeResults - Serum vs. Plasma
ACE
94 pairs11-1234 U/LSlope: 0.997
Intercept: -0.5
Correlation: 0.9965
Std. Error Est: 23.5
Confidence Interval Slope: 0.980 to 1.014
Confidence Interval Intercept: -6.3 to 5.2
ACE Alera
96 pairs14-1211 U/LSlope: 0.978
Intercept: 0.1
Correlation: 0.9960
Std. Error Est: 22.1
Confidence Interval Slope: 0.960 to 0.996
Confidence Interval Intercept: -5.2 to 5.5
ACE Axcel
55 pairs17-1315 U/LSlope: 1.006
Intercept: -0.50
Correlation: 0.9990
Std. Error Est: 13.24
Confidence Interval Slope: 0.993 to 1.019
Confidence 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/UreaACE ResultACE Alera Result
mg/dL SD, %CVmg/dL SD, %CV
LabSampleMeanWithin-
RunTotalMeanWithin-
RunTotal
In-House180.00 SD
0.0%0.30 SD
4.0%80.40 SD
5.5%0.60 SD
7.7%
POL 1180.30 SD
3.9%0.30 SD
3.9%90.40 SD
4.5%0.50 SD
6.2%
POL 2180.40 SD
4.4%0.50 SD
5.6%80.20 SD
2.8%0.40 SD
4.9%
POL 3180.30 SD
3.9%0.30 SD
3.9%90.30 SD
3.6%0.70 SD
8.3%
In-House2411.90 SD
4.7%2.00 SD
5.0%421.30 SD
3.2%1.60 SD
3.9%
POL 12430.40 SD
1.0%0.80 SD
1.9%431.40 SD
3.4%1.70 SD
4.0%
POL 22420.30 SD
0.7%1.40 SD
3.3%411.10 SD
2.7%1.80 SD
4.4%
POL 32421.00 SD
2.4%1.10 SD
2.6%440.70 SD
1.7%1.40 SD
3.3%
In-House3741.10 SD
1.5%2.40 SD
3.2%750.40 SD
0.5%2.00 SD
2.6%
POL 13751.30 SD
1.8%1.30 SD
1.8%761.20 SD
1.6%1.80 SD
2.4%
POL 23731.30 SD
1.8%2.30 SD
3.1%741.70 SD
2.3%2.80 SD
3.7%
POL 33761.20 SD
1.6%1.40 SD
1.9%761.10 SD
1.4%2.20 SD
2.9%

11

Performance Data at POL:

Precision -

1

· ·

.

POL

POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

| Creatinine | | ACE Result
mg/dL SD, %CV | | | ACE Alera Result
mg/dL SD, %CV | | |
|------------|--------|-----------------------------|-----------------|-----------------|-----------------------------------|-----------------|-----------------|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 0.58 | 0.04 SD
6.4% | 0.05 SD
8.8% | 0.58 | 0.02 SD
3.2% | 0.03 SD
5.3% |
| POL 1 | 1 | 0.51 | 0.03 SD
5.6% | 0.04 SD
8.4% | 0.53 | 0.03 SD
6.0% | 0.05 SD
9.3% |
| POL 2 | 1 | 0.54 | 0.04 SD
6.9% | 0.05 SD
9.8% | 0.56 | 0.02 SD
4.2% | 0.03 SD
4.4% |
| POL 3 | 1 | 0.53 | 0.04 SD
6.6% | 0.04 SD
7.5% | 0.55 | 0.02 SD
4.3% | 0.04 SD
6.3% |
| In-House | 2 | 8.29 | 0.09 SD
1.0% | 0.32 SD
3.9% | 8.08 | 0.11 SD
1.3% | 0.28 SD
3.5% |
| POL 1 | 2 | 7.97 | 0.08 SD
1.0% | 0.20 SD
2.5% | 7.84 | 0.08 SD
1.1% | 0.15 SD
1.9% |
| POL 2 | 2 | 7.60 | 0.11 SD
1.4% | 0.43 SD
5.7% | 8.21 | 0.14 SD
1.7% | 0.23 SD
2.8% |
| POL 3 | 2 | 7.89 | 0.11 SD
1.4% | 0.13 SD
1.7% | 7.98 | 0.09 SD
1.1% | 0.23 SD
2.9% |
| In-House | 3 | 12.92 | 0.18 SD
1.4% | 0.46 SD
3.5% | 12.65 | 0.07 SD
0.5% | 0.42 SD
3.3% |
| POL 1 | 3 | 12.42 | 0.23 SD
1.9% | 0.37SD
3.0% | 12.32 | 0.10 SD
0.9% | 0.42 SD
3.4% |
| POL 2 | 3 | 11.67 | 0.22 SD
1.9% | 0.53 SD
4.5% | 12.81 | 0.31 SD
2.4% | 0.50 SD
3.9% |
| POL 3 | 3 | 12.28 | 0.17 SD
1.4% | 0.18 SD
1.5% | 12.27 | 0.12 SD
1.0% | 0.44 SD
3.6% |

  • 12

12

POL – Precision for ACE and ACE Alera Clinical Chemistry Systems

Performance Data at POL:

Precision -POL

| Uric Acid | | | | ACE Result
mg/dL SD, %CV | | | ACE Alera Result
mg/dL SD, %CV | |
|--------------|--------|------|--|-----------------------------|-----------------|------|-----------------------------------|-----------------|
| Lab | Sample | Mean | | Within-
Run | Total | Mean | Within-
Run | Total |
| In-
House | 1 | 2.9 | | 0.19 SD
6.5% | 0.19 SD
6.5% | 2.9 | 0.10 SD
3.5% | 0.13 SD
4.5% |
| POL 1 | 1 | 3.0 | | 0.05 SD
1.7% | 0.09 SD
3.1% | 3.0 | 0.15 SD
5.2% | 0.16 SD
5.3% |
| POL 2 | 1 | 2.8 | | 0.10 SD
3.5% | 0.11 SD
4.0% | 2.9 | 0.09 SD
3.1% | 0.10 SD
3.6% |
| POL 3 | 1 | 2.9 | | 0.06 SD
2.2% | 0.14 SD
5.0% | 3.2 | 0.05 SD
1.6% | 0.09 SD
2.9% |
| In-
House | 2 | 8.0 | | 0.13 SD
1.6% | 0.15 SD
1.9% | 8.0 | 0.05 SD
0.7% | 0.17 SD
2.1% |
| POL 1 | 2 | 7.7 | | 0.05 SD
0.6% | 0.11 SD
1.4% | 7.6 | 0.13 SD
1.7% | 0.21 SD
2.8% |
| POL 2 | 2 | 7.5 | | 0.13 SD
1.7% | 0.16 SD
2.2% | 7.5 | 0.08 SD
1.0% | 0.13 SD
1.8% |
| POL 3 | 2 | 7.9 | | 0.10 SD
1.2% | 0.13 SD
1.7% | 7.9 | 0.07 SD
0.9% | 0.25 SD
3.1% |
| In-
House | 3 | 12.5 | | 0.35 SD
2.8% | 0.38 SD
3.0% | 12.7 | 0.18 SD
1.4% | 0.22 SD
1.7% |
| POL 1 | 3 | 12.0 | | 0.13 SD
1.1% | 0.28 SD
2.4% | 11.9 | 0.14 SD
1.2% | 0.26 SD
2.2% |
| POL 2 | 3 | 11.8 | | 0.29 SD
2.5% | 0.32 SD
2.7% | 11.6 | 0.27 SD
2.4% | 0.27 SD
2.4% |
| POL 3 | 3 | 12.3 | | 0.11 SD
0.9% | 0.12 SD
1.0% | 12.2 | 0.15 SD
1.2% | 0.35 SD
2.9% |

13

Performance Data at POL:

Data at T.O.E.

Precision -POL

POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

| CK | | | ACE Result
mg/dL SD, %CV | | | ACE Alera Result
mg/dL SD, %CV | |
|----------|--------|------|-----------------------------|-----------------|------|-----------------------------------|------------------|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 77 | 3.20 SD
4.2% | 4.00 SD
5.2% | 75 | 2.50 SD
3.3% | 3.30 SD
4.4% |
| POL 1 | 1 | 70 | 1.40 SD
2.0% | 2.90 SD
4.1% | 73 | 1.40 SD
1.9% | 2.60 SD
3.6% |
| POL 2 | 1 | 69 | 1.90 SD
2.7% | 3.00 SD
4.4% | 70 | 2.20 SD
3.2% | 3.50 SD
5.0% |
| POL 3 | 1 | 79 | 2.60 SD
3.2% | 2.70 SD
3.4% | 70 | 2.10 SD
3.0% | 4.10 SD
5.9% |
| In-House | 2 | 521 | 6.70 SD
1.3% | 7.20 SD
1.4% | 516 | 8.00 SD
1.5% | 8.10 SD
1.6% |
| POL 1 | 2 | 568 | 4.90 SD
0.9% | 6.90 SD
1.2% | 567 | 10.00 SD
1.8% | 14.00 SD
2.5% |
| POL 2 | 2 | 526 | 3.90 SD
0.7% | 9.20 SD
1.8% | 514 | 6.50 SD
1.3% | 8.80 SD
1.7% |
| POL 3 | 2 | 540 | 4.00 SD
0.7% | 4.30 SD
0.8% | 559 | 6.90 SD
1.2% | 14.10 SD
2.5% |
| In-House | 3 | 907 | 10.90SD
1.2% | 14.60SD
1.6% | 905 | 9.50 SD
1.1% | 14.00 SD
1.6% |
| POL 1 | 3 | 967 | 22.00SD
2.3% | 22.70SD
2.3% | 995 | 7.60 SD
0.8% | 14.40 SD
1.4% |
| POL 2 | 3 | 929 | 18.60SD
2.0% | 18.90SD
2.0% | 899 | 11.40SD
1.3% | 11.60SD
1.3% |
| POL 3 | 3 | 950 | 7.80 SD
0.8% | 9.90 SD
1.0% | 977 | 13.00SD
1.3% | 19.60 SD
2.0% |

:

. . . . .

14

| Performance

Data:POL – Method Comparison for ACE Clinical Chemistry System
Method
Comparison -
POL on ACEReagentStatisticIn-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)
BUNn535454
Range3 to 883 to 883 to 88
Regression$y = 1.034x - 0.1$$y = 1.025x + 0.0$$y = 1.031x + 0.0$
Correlation0.99890.99850.9990
Std. Error Est.0.91.10.9
CI Slope1.020 to 1.0471.010 to 1.0401.018 to 1.044
CI Intercept-0.5 to 0.2-0.4 to 0.5-0.3 to 0.4
Creatininen515151
Range0.34 to 22.570.34 to 22.570.34 to 22.57
Regression$y = 1.032x - 0.010$$y = 1.010x - 0.046$$y = 0.986x - 0.017$
Correlation0.99940.99970.9999
Std. Error Est.0.1480.1000.060
CI Slope1.022 to 1.0421.003 to 1.0160.982 to 0.990
CI Intercept-0.057 to 0.037-0.078 to -0.014-0.036 to 0.002
Uric Acidn494949
Range1.7 to 14.51.7 to 14.51.7 to 14.5
Regression$y = 0.988x + 0.23$$y = 1.018x - 0.06$$y = 1.009x + 0.03$
Correlation0.99390.99570.9969
Std. Error Est.0.270.230.19
CI Slope0.956 to 1.0200.991 to 1.0460.985 to 1.032
CI Intercept0.01 to 0.45-0.25 to 0.13-0.13 to 0.19
Creatinine
kinasen504849
Range11 to 120411 to 120411 to 1204
Regression$y = 1.010x - 7.7$$y = 0.989x - 8.0$$y = 0.986x - 1.8$
Correlation0.99760.99870.9996
Std. Error Est.19.213.97.7
CI Slope0.990 to 1.0310.974 to 1.0040.978 to 0.995
CI Intercept-14.7 to -0.7-13.2 to -2.8-4.6 to 1.1

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15

11 - 11

15

| Performance
Data at POL:
Method
Comparison -
POL on ACE
Alera | Reagent | 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 |
| Creatinine
Kinase | | 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

| ACE
Reagents | Low
level
tested | Upper level
tested | Linear to: | Linear Regression
Equation | Correlation
Coefficients
R^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

| ACE
Alera | Icterus | Hemolysis | Lipemia
(Intralipid)/
Triglycerides | Ascorbic Acid |
|--------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|
| BUN | No significant
interference at or
below 70 mg/dL | No significant
interference at or
below 500 mg/dL | No significant
interference at or
below 2080 mg/dL
Triglycerides | No significant
interference at or
below 6 mg/dL |
| Creatinine | No significant
interference at or
below 6.0 mg/dL | No significant
interference at or
below 1000 mg/dL | No significant
interference at or
below 2080 mg/dL
Triglycerides | . No significant
interference at or
below 6 mg/dL |
| UA | No significant
interference at or
below 16.9 mg/dL | No significant
interference at or
below 125 mg/dL | No significant
interference at or
below 893 mg/dL
Triglycerides | No significant
interference at or
below 1.313
mg/dL |
| CK | No significant
interference at or
below 30 mg/dL | No significant
interference at or
below 125 mg/dL | No significant
interference at or
below 2372 mg/dL
Triglycerides | No significant
interference at or
below 6 mg/dL |

18

Precision - ACE Alera Clinical Chemistry System

Performance Data:

ACE Alera

on ACE AleraMeanPrecision (SD, %CV)
Within-RunTotal
BUN
mg/dLLow150.3, 2.1%0.5, 3.1%
BUN
mg/dLMid420.7, 1.7%1.3, 3.0%
BUN
mg/dLHigh741.5, 2.0%2.3, 3.2%
Creatinine
mg/dLLow0.90.03, 3.9%0.08, 9.8%
Creatinine
mg/dLMid1.70.04, 2.4%0.12, 7.5%
Creatinine
mg/dLHigh5.40.13, 2.5%0.22, 4.1%
Uric Acid
mg/dLLow3.50.10, 3.0%0.18, 5.2%
Uric Acid
mg/dLMid6.00.14, 2.3%0.25, 4.1%
Uric Acid
mg/dLHigh11.60.32, 2.8%0.55, 4.7%
CK
U/LLow1282.2, 1.7%3.8, 3.0%
CK
U/LMid3786.8, 1.8%11.5, 3.0%
CK
U/LHigh8658.5, 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)
n53515049
Range3 - 880.34 - 22.571.7 - 14.511 - 1204
Slope1.0001.0160.9920.991
Intercept0.1-0.0020.05-1.3
Correlation
Coefficient0.99880.99970.99780.9999
Std. Error0.90.1110.17-1.3
CI Slope0.986 to 1.0141.008 to 1.0230.973 to 1.0100.987 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

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and the comments of the comments of

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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:

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.

Device Name: ACE Creatinine Reagent

Indications for Use:

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

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:

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.

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 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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