ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

K103615 · Alfa Wassermann Diagnostic Technologies, Inc. · CDN · Sep 8, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103615
• Device Name: ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: CDN · Clinical Chemistry
• Decision Date: Sep 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The ACE Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium in urine using the ACE and ACE Alera Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Creatinine Reagent is intended for the quantitative determination of creatinine in urine using the ACE and ACE Alera Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Standard is intended for the calibration of quantitative urine reagents on Alfa Wassermann Clinical Chemistry Systems. For in vitro diagnostic use only.

Device Story

Reagents for quantitative urine analysis on ACE/ACE Alera Clinical Chemistry Systems; inputs are urine samples; samples prediluted 1:20 with system diluent; reagents mixed with sample in cuvettes; photometric detection of chemical reactions; Urea Nitrogen (enzymatic/kinetic); Calcium (Arsenazo III dye-binding/endpoint); Creatinine (alkaline picrate/endpoint); Inorganic Phosphorus (phosphomolybdate/endpoint); output is analyte concentration; used in clinical/physician office labs; results used by clinicians for diagnosis/treatment of renal/metabolic/bone disorders.

Clinical Evidence

Bench testing only. Precision studies (within-run CV 0.4-6.9%, total CV 0.6-7.5%) and accuracy/correlation studies (n=108-113 per analyte) performed on ACE and ACE Alera systems against predicate methods. Correlation coefficients ranged from 0.9669 to 0.9954. Detection limits established for all analytes.

Technological Characteristics

Reagents: Urea (urease, glutamate dehydrogenase, NADH), Calcium (Arsenazo III), Creatinine (picric acid, sodium hydroxide), Phosphorus (ammonium molybdate, sulfuric acid). Sensing: Photometric/colorimetric detection (bichromatic). Connectivity: Integrated with ACE/ACE Alera Clinical Chemistry Systems. Form factor: Liquid, ready-to-use reagents and calibrators.

Indications for Use

Indicated for quantitative determination of urea nitrogen, calcium, creatinine, and inorganic phosphorus in urine for diagnosis/treatment of renal, metabolic, parathyroid, and bone diseases. Intended for use in clinical laboratories and physician office laboratories.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics COBAS Integra Urea/BUN (k954000)
• Roche Diagnostics COBAS Integra Calcium (k896224)
• Roche Diagnostics COBAS Integra Creatinine Jaffe Gen. 2 (k941837)
• Roche Diagnostics COBAS Integra Phosphate Inorganic ver. 2 (k883962)
• Verichem Laboratories Urine Chemistry Standard (k875285)

Submission Summary (Full Text)

{0}------------------------------------------------

K 103615

## 510(k) SUMMARY

SEP - 8 2011

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Contact: | Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary<br>Prepared: | Dec 7, 2010 [Date Updated: August 19, 2011] | |
| Device: | Trade Name: | ACE Urea Nitrogen Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Urease, Photometric, Urea<br>Nitrogen<br>(21 C.F.R. § 862.1770)<br>Product Code CDN |
| | Trade Name: | ACE Calcium-Arsenazo Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Azo Dye, Calcium<br>(21 C.F.R. § 862.1145)<br>Product Code CJY |
| | Trade Name: | ACE Creatinine Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Alkaline Picrate, Colorimetry,<br>Creatinine (21 C.F.R. § 862.1225)<br>Product Code CGX |
| | Trade Name:<br>Reagent | ACE Inorganic Phosphorus U.V. |
| | Classification: | Class 1 |
| | Common/Classification Name: | Phosphomolybdate (Colorimetric),<br>Inorganic Phosphorus<br>(21 C.F.R. § 862.1580)<br>Product Code CEO |
| | Trade Name: | ACE Urine Standard |
| | Classification: | Class 2 |
| | Common/Classification Name: | Calibrator, Multianalyte Mixture<br>(21 C.F.R. § 862.1150)<br>Product Code JIX |
| Predicate<br>Devices: | Manufacturer for the reagent system predicate devices: | |
| | Roche Diagnostics COBAS INTEGRA reagents: | |
| | Reagent | 510(k)# |
| | Urea/BUN | K954000 |
| | Calcium | K896224 |
| | Phosphate (Inorganic) ver.2 | K883962 |
| | Siemens Healthcare Diagnostics ADVIA 1800/2400 reagent: | |
| | Reagent | 510(k)# |
| | Creatinine (CRE_2c) | K901229 |
| | Verichem Laboratories, Inc. standard: | |
| | Reagent | 510(k)# |
| | Urine Chemistry Standard | K875285 |
| Device<br>Descriptions: | In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed to<br>yield ammonia and carbon dioxide in the presence of urease. The<br>ammonia formed then reacts with 2-oxoglutarate and NADH in the<br>presence of glutamate dehydrogenase to yield glutamate and NAD.<br>Two moles of NADH are oxidized for each mole of urea present.<br>NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial<br>rate of decrease in absorbance, monitored bichromatically at 340<br>nm/647 nm, is proportional to the urea concentration in the urine<br>sample. | |
| | In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with<br>Arsenazo III in an acidic solution to form a blue-purple colored<br>complex, which is measured bichromatically at 647 nm/692 nm. The<br>intensity of color produced is directly proportional to the calcium<br>concentration in the urine sample. | |
| | In the ACE Creatinine Reagent assay, creatinine reacts with picric acid<br>in an alkaline medium to form a red-orange colored complex, which<br>absorbs strongly at 505 nm. The rate of complex formation, determined<br>by measuring the increase in absorbance bichromatically at 505 nm/573<br>nm during a fixed time interval, is directly proportional to the<br>creatinine concentration in the urine sample. | |
| | In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic<br>conditions, inorganic phosphorus reacts with ammonium molybdate to<br>form an unreduced phosphomolybdate complex, which absorbs<br>strongly at 340 nm The increase in absorbance measured | |
| Intended Use: | | |
| | bichromatically at 340 nm/378 nm, is directly proportional to the<br>amount of phosphorus in the urine sample. | |
| | The ACE urine standard is a liquid, aqueous-based, ready-to-use<br>calibration solution with known gravimetric concentrations of several<br>analytes. | |
| | Indications for Use: | |
| | The ACE Urea Nitrogen Reagent is intended for the quantitative<br>determination of urea nitrogen concentration in serum and urine using<br>the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen<br>measurements are used in the diagnosis and treatment of certain renal<br>and metabolic diseases. This test is intended for use in clinical<br>laboratories or physician office laboratories. For <i>in vitro</i> diagnostic use<br>only. | |
| | The ACE Calcium-Arsenazo Reagent is intended for the quantitative<br>determination of calcium in serum and urine using the ACE and ACE<br>Alera Clinical Chemistry Systems. Calcium measurements are used in<br>the diagnosis and treatment of parathyroid disease, a variety of bone<br>diseases, chronic renal disease and tetany. This test is intended for use<br>in clinical laboratories or physician office laboratories. For <i>in vitro</i><br>diagnostic use only. | |
| | The ACE Creatinine Reagent is intended for the quantitative<br>determination of creatinine in serum and urine using the ACE and ACE<br>Alera Clinical Chemistry Systems. Creatinine measurements are used<br>in the diagnosis and treatment of renal diseases, in monitoring renal<br>dialysis and as a calculation basis for measuring other urine analytes.<br>This test is intended for use in clinical laboratories or physician office<br>laboratories. For <i>in vitro</i> diagnostic use only. | |
|…