(273 days)
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No
The device description details chemical reactions and photometric measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic reagent used to measure concentrations of substances in urine for diagnostic purposes, not to directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents are used for "diagnosis and treatment of certain renal and metabolic diseases," "diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany," "diagnosis and treatment of renal diseases," and "diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance." Additionally, it mentions "For in vitro diagnostic use only."
No
The device description clearly outlines chemical reagents and a standard solution used in conjunction with clinical chemistry systems (hardware) to perform in vitro diagnostic tests. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for each reagent and the standard explicitly states "For in vitro diagnostic use only."
- Intended Use: The intended use is to quantitatively determine the concentration of specific analytes (urea nitrogen, calcium, creatinine, inorganic phosphorus) in urine samples. This is a classic example of an in vitro diagnostic test, as it involves analyzing a biological sample outside of the body to provide information for diagnosis and treatment.
- Clinical Context: The results of these tests are used in the "diagnosis and treatment of certain renal and metabolic diseases," "parathyroid disease, a variety of bone diseases, chronic renal disease and tetany," "renal diseases, in monitoring renal dialysis," and "parathyroid gland and kidney diseases and vitamin D imbalance." This clearly indicates a medical purpose for the testing.
- Care Setting: The intended users are "clinical laboratories or physician office laboratories," which are settings where IVD tests are typically performed.
- Device Description: The device description details the chemical reactions used to measure the analytes in the urine sample, which is characteristic of an in vitro diagnostic reagent.
- Performance Studies: The inclusion of performance studies (precision, accuracy, detection limit) is standard for IVD devices to demonstrate their reliability for clinical use.
- Predicate Devices: The listing of predicate devices with K numbers (FDA premarket notification numbers) further confirms that these are regulated medical devices, specifically IVDs. The predicate devices are also IVD reagents and standards used for similar purposes.
All of these factors strongly indicate that the described reagents and standard are intended for use as in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The ACE Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen concentration in serum and 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 serum and 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 serum and 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 serum and 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.
Product codes (comma separated list FDA assigned to the subject device)
CDN, CJY, CGX, CEO, JIX
Device Description
In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the urine sample.
In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the urine sample.
In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the urine sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm The increase in absorbance measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the urine sample.
The ACE urine standard is a liquid, aqueous-based, ready-to-use calibration solution with known gravimetric concentrations of several analytes.
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.
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)
Performance data for the Alfa Wassermann ACE reagents for urine testing included precision, accuracy and detection limit data.
ACE Urea Nitrogen Reagent
Precision: In testing conducted at five urea nitrogen levels for 22 days, on 2 different instruments, the within-run CV ranged from 1.1 to 2.3% and total CV ranged from 2.0 to 3.5%. In precision studies at three urea nitrogen levels at four separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 to 3.8% and total CV ranged from 1.6 to 4.6%.
Accuracy: In one correlation study, 112 samples with urea nitrogen values ranging from 42 to 1883 mg/dL were assayed on the Alfa Wassermann ACE System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9769, a standard error estimate of 71.1, a confidence interval slope of 0.871 to 0.945 and a confidence interval intercept of 7.9 to 68.9. In another correlation study, 112 samples with urea nitrogen values ranging from 48 to 1850 mg/dL were assayed on the Alfa Wassermann ACE Alera Clinical Chemistry System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9805, a standard error estimate of 66.2, a confidence interval slope of 0.884 to 0.953, and a confidence interval intercept of -5.9 to 50.9. In patient correlation studies at four separate POL sites, using the Alfa Wassermann ACE reagents and the predicate device (x), least-squares regression analysis yielded correlation coefficients of 0.9853 to 0.9895, standard error estimates of 61.5 to 75.1, confidence interval slopes of 0.866 to 0.993, and confidence interval intercepts of -49.7 to 61.8.
Detection limit: The detection limit was 10 mg/dL on the ACE and 14 mg/dL on the ACE Alera Clinical Chemistry Systems.
ACE Calcium-Arsenazo Reagent
Precision: In testing conducted at four calcium levels for 22 days, on 2 different instruments, the within-run CV ranged from 1.4 to 5.3% and total CV ranged from 1.6 to 5.7%. In precision studies at three calcium levels at four separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 6.9% and total CV ranged from 0.8 to 7.5%.
Accuracy: In one correlation study, 108 samples with calcium values ranging from 1.1 to 28.8 mg/dL were assayed on the Alfa Wassermann ACE System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9752, a standard error estimate of 1.35, a confidence interval slope of 0.973 to 1.060 and a confidence interval intercept of -0.37 to 0.76. In another correlation study, 109 samples with calcium values ranging from 1.0 to 28.8 mg/dL were assayed on the Alfa Wassermann ACE Alera Clinical Chemistry System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9752, a standard error estimate of 1.37, a confidence interval slope of 0.979 to 1.066 and a confidence interval intercept of -0.46 to 0.66. In patient correlation studies at four separate POL sites, using the Alfa Wassermann ACE reagents and the predicate device (x), least-squares regression analysis yielded correlation coefficients of 0.9669 to 0.9810, standard error estimates of 1.35 to 1.70, confidence interval slopes of 0.935 to 1.125 and confidence interval intercepts of -1.64 to 1.24.
Detection limit: The detection limit was 0.3 mg/dL on the ACE and 0.3 mg/dL on the ACE Alera Clinical Chemistry Systems.
ACE Creatinine Reagent
Precision: In testing conducted at five creatinine levels for 22 days, on 2 different instruments, the within-run CV ranged from 1.0 to 2.1% and total CV ranged from 2.6 to 3.3%. In precision studies at three creatinine levels at four separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 3.5% and total CV ranged from 1.5 to 5.8%.
Accuracy: In one correlation study, 113 samples with creatinine values ranging from 8.2 to 308.7 mg/dL were assayed on the Alfa Wassermann ACE System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9818, a standard error estimate of 11.40, a confidence interval slope of 0.950 to 1.021 and a confidence interval intercept of 2.62 to 10.92. In another correlation study, 113 samples with creatinine values ranging from 8.5 to 329.1 mg/dL were assayed on the Alfa Wassermann ACE Alera Clinical Chemistry System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9817, a standard error estimate of 11.95, a confidence interval slope of 0.992 to 1.066, and a confidence interval intercept of -3.25 to 5.44. In patient correlation studies at four separate POL sites, using the Alfa Wassermann ACE reagents and the predicate device (x), least-squares regression analysis yielded correlation coefficients of 0.9882 to 0.9904, standard error estimates of 10.72 to 12.24, confidence interval slopes of 0.928 to 1.101 and confidence interval intercepts of -6.84 to 9.66.
Detection limit: The detection limit was 0.8 mg/dL on the ACE and 1.2 mg/dL on the ACE Alera Clinical Chemistry Systems.
ACE Inorganic Phosphorus U.V. Reagent
Precision: In testing conducted at five phosphorus levels for 22 days, on 2 different instruments, the within-run CV ranged from 0.7 to 2.2% and total CV ranged from 0.8 to 3.4%. In precision studies at three phosphorus levels at four separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.4 to 3.3% and total CV ranged from 0.6 to 4.6%.
Accuracy: In one correlation study, 113 samples with phosphorus values ranging from 6.1 to 182.4 mg/dL were assayed on the Alfa Wassermann ACE System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9878, a standard error estimate of 5.21, a confidence interval slope of 0.960 to 1.018 and a confidence interval intercept of 1.30 to 5.34. In another correlation study, 112 samples with phosphorus values ranging from 5.9 to 175.0 mg/dL were assayed on the Alfa Wassermann ACE Alera Clinical Chemistry System (y) and the predicate method (x). Least squares regression analysis yielded a correlation coefficient of 0.9886, a standard error estimate of 4.89, a confidence interval slope of 0.940 to 0.995 and a confidence interval intercept of 2.06 to 5.91. In patient correlation studies at four separate POL sites, using the Alfa Wassermann ACE reagents and the predicate device (x), least-squares regression analysis yielded correlation coefficients of 0.9809 to 0.9954, standard error estimates of 3.88 to 8.40, confidence interval slopes of 0.885 to 1.030 and confidence interval intercepts of -1.13 to 7.46.
Detection limit: The detection limit was 1.6 mg/dL on the ACE and 1.2 mg/dL on the ACE Alera Clinical Chemistry Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954000, K896224, K883962, K901229, K875285
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 103615
510(k) SUMMARY
SEP - 8 2011
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 |
| Date Summary
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
Nitrogen
(21 C.F.R. § 862.1770)
Product Code CDN |
| | Trade Name: | ACE Calcium-Arsenazo Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Azo Dye, Calcium
(21 C.F.R. § 862.1145)
Product Code CJY |
| | Trade Name: | ACE Creatinine Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Alkaline Picrate, Colorimetry,
Creatinine (21 C.F.R. § 862.1225)
Product Code CGX |
| | Trade Name:
Reagent | ACE Inorganic Phosphorus U.V. |
| | Classification: | Class 1 |
| | Common/Classification Name: | Phosphomolybdate (Colorimetric),
Inorganic Phosphorus
(21 C.F.R. § 862.1580)
Product Code CEO |
| | Trade Name: | ACE Urine Standard |
| | Classification: | Class 2 |
| | Common/Classification Name: | Calibrator, Multianalyte Mixture
(21 C.F.R. § 862.1150)
Product Code JIX |
| Predicate
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
Descriptions: | In the ACE Urea Nitrogen Reagent assay, urea in urine is hydrolyzed to
yield ammonia and carbon dioxide in the presence of urease. The
ammonia formed then reacts with 2-oxoglutarate and NADH in the
presence of glutamate dehydrogenase to yield glutamate and NAD.
Two moles of NADH are oxidized for each mole of urea present.
NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial
rate of decrease in absorbance, monitored bichromatically at 340
nm/647 nm, is proportional to the urea concentration in the urine
sample. | |
| | In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with
Arsenazo III in an acidic solution to form a blue-purple colored
complex, which is measured bichromatically at 647 nm/692 nm. The
intensity of color produced is directly proportional to the calcium
concentration in the urine sample. | |
| | In the ACE Creatinine Reagent assay, creatinine reacts with picric acid
in an alkaline medium to form a red-orange colored complex, which
absorbs strongly at 505 nm. The rate of complex formation, determined
by measuring the increase in absorbance bichromatically at 505 nm/573
nm during a fixed time interval, is directly proportional to the
creatinine concentration in the urine sample. | |
| | In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic
conditions, inorganic phosphorus reacts with ammonium molybdate to
form an unreduced phosphomolybdate complex, which absorbs
strongly at 340 nm The increase in absorbance measured | |
| Intended Use: | | |
| | bichromatically at 340 nm/378 nm, is directly proportional to the
amount of phosphorus in the urine sample. | |
| | The ACE urine standard is a liquid, aqueous-based, ready-to-use
calibration solution with known gravimetric concentrations of several
analytes. | |
| | Indications for Use: | |
| | The ACE Urea Nitrogen Reagent is intended for the quantitative
determination of urea nitrogen concentration in serum and 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 serum and 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 serum and 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
serum and 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. | |
| Technological
Characteristics: | The ACE Urea Nitrogen Reagent consists of a single reagent bottle.
The reagent contains α-ketoglutarate, urease, glutamate dehydrogenase,
adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and
reduced (NADH). | |
| The ACE Calcium-Arsenazo Reagent consists of a single reagent
bottle. The Reagent contains Arsenazo III. | | |
| The ACE Creatinine Reagent consists of two reagent bottles (Sodium
Hydroxide Reagent and Picric Acid Reagent). The Sodium Hydroxide
Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent
(R2) contains picric acid. | | |
| The ACE Inorganic Phosphorus U.V. Reagent consists of a single
reagent bottle. The reagent contains ammonium molybdate and sulfuric
acid. | | |
| The ACE Urine Standard consists of a single dropper bottle. The
standard contains known amounts of urea nitrogen, calcium, creatinine
and phosphorus. | | |
| Performance
Data: | Performance data for the Alfa Wassermann ACE reagents for urine
testing included precision, accuracy and detection limit data. | |
| ACE Urea Nitrogen Reagent | | |
| Precision: In testing conducted at five urea nitrogen levels for 22 days,
on 2 different instruments, the within-run CV ranged from 1.1 to 2.3%
and total CV ranged from 2.0 to 3.5%. In precision studies at three urea
nitrogen levels at four separate Physician Office Laboratory (POL) sites
over 5 days, the within-run CV ranged from 0.9 to 3.8% and total CV
ranged from 1.6 to 4.6%. | | |
| Accuracy: In one correlation study, 112 samples with urea nitrogen
values ranging from 42 to 1883 mg/dL were assayed on the Alfa
Wassermann ACE System (y) and the predicate method (x). Least
squares regression analysis yielded a correlation coefficient of 0.9769,
a standard error estimate of 71.1, a confidence interval slope of 0.871 to
0.945 and a confidence interval intercept of 7.9 to 68.9. In another
correlation study, 112 samples with urea nitrogen values ranging from
48 to 1850 mg/dL were assayed on the Alfa Wassermann ACE Alera
Clinical Chemistry System (y) and the predicate method (x). Least
squares regression analysis yielded a correlation coefficient of 0.9805,
a standard error estimate of 66.2, a confidence interval slope of 0.884 to
0.953, and a confidence interval intercept of -5.9 to 50.9. In patient
correlation studies at four separate POL sites, using the Alfa
Wassermann ACE reagents and the predicate device (x), least-squares
regression analysis yielded correlation coefficients of 0.9853 to 0.9895,
standard error estimates of 61.5 to 75.1, confidence interval slopes of
0.866 to 0.993, and confidence interval intercepts of -49.7 to 61.8. | | |
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| Detection limit: The detection limit was 10 mg/dL on the ACE and 14
| mg/dL on the ACE Alera Clinical Chemistry Systems. | |
|---|---|
| ACE Calcium-Arsenazo Reagent | |
| Precision: In testing conducted at four calcium levels for 22 days, on 2 | |
| different instruments, the within-run CV ranged from 1.4 to 5.3% and | |
| total CV ranged from 1.6 to 5.7%. In precision studies at three calcium | |
| levels at four separate Physician Office Laboratory (POL) sites over 5 | |
| days, the within-run CV ranged from 0.8 to 6.9% and total CV ranged | |
| from 0.8 to 7.5%. | |
| Accuracy: In one correlation study, 108 samples with calcium values | |
| ranging from 1.1 to 28.8 mg/dL were assayed on the Alfa Wassermann | |
| ACE System (y) and the predicate method (x). Least squares regression | |
| analysis yielded a correlation coefficient of 0.9752, a standard error | |
| estimate of 1.35, a confidence interval slope of 0.973 to 1.060 and a | |
| confidence interval intercept of -0.37 to 0.76. In another correlation | |
| study, 109 samples with calcium values ranging from 1.0 to 28.8 | |
| mg/dL were assayed on the Alfa Wassermann ACE Alera Clinical | |
| Chemistry System (y) and the predicate method (x). Least squares | |
| regression analysis yielded a correlation coefficient of 0.9752, a | |
| standard error estimate of 1.37, a confidence interval slope of 0.979 to | |
| 1.066 and a confidence interval intercept of -0.46 to 0.66. In patient | |
| correlation studies at four separate POL sites, using the Alfa | |
| Wassermann ACE reagents and the predicate device (x), least-squares | |
| regression analysis yielded correlation coefficients of 0.9669 to 0.9810, | |
| standard error estimates of 1.35 to 1.70, confidence interval slopes of | |
| 0.935 to 1.125 and confidence interval intercepts of -1.64 to 1.24. | |
| Detection limit: The detection limit was 0.3 mg/dL on the ACE and 0.3 | |
| mg/dL on the ACE Alera Clinical Chemistry Systems. | |
| ACE Creatinine Reagent | |
| Precision: In testing conducted at five creatinine levels for 22 days, on | |
| 2 different instruments, the within-run CV ranged from 1.0 to 2.1% and | |
| total CV ranged from 2.6 to 3.3%. In precision studies at three | |
| creatinine levels at four separate Physician Office Laboratory (POL) | |
| sites over 5 days, the within-run CV ranged from 0.8 to 3.5% and total | |
| CV ranged from 1.5 to 5.8%. | |
| Accuracy: In one correlation study, 113 samples with creatinine values | |
| ranging from 8.2 to 308.7 mg/dL were assayed on the Alfa | |
| Wassermann ACE System (y) and the predicate method (x). Least | |
| squares regression analysis yielded a correlation coefficient of 0.9818, | |
| a standard error estimate of 11.40, a confidence interval slope of 0.950 | |
| to 1.021 and a confidence interval intercept of 2.62 to 10.92. In another | |
| correlation study, 113 samples with creatinine values ranging from 8.5 | |
| to 329.1 mg/dL were assayed on the Alfa Wassermann ACE Alera | |
| Clinical Chemistry System (y) and the predicate method (x). Least | |
| squares regression analysis yielded a correlation coefficient of 0.9817, | |
| a standard error estimate of 11.95, a confidence interval slope of 0.992 | |
| to 1.066, and a confidence interval intercept of -3.25 to 5.44. In patient | |
| correlation studies at four separate POL sites, using the Alfa | |
| Wassermann ACE reagents and the predicate device (x), least-squares | |
| regression analysis yielded correlation coefficients of 0.9882 to 0.9904, | |
| standard error estimates of 10.72 to 12.24, confidence interval slopes of | |
| 0.928 to 1.101 and confidence interval intercepts of -6.84 to 9.66. | |
| Detection limit: The detection limit was 0.8 mg/dL on the ACE and 1.2 | |
| mg/dL on the ACE Alera Clinical Chemistry Systems. | |
| ACE Inorganic Phosphorus U.V. Reagent | |
| Precision: In testing conducted at five phosphorus levels for 22 days, | |
| on 2 different instruments, the within-run CV ranged from 0.7 to 2.2% | |
| and total CV ranged from 0.8 to 3.4%. In precision studies at three | |
| phosphorus levels at four separate Physician Office Laboratory (POL) | |
| sites over 5 days, the within-run CV ranged from 0.4 to 3.3% and total | |
| CV ranged from 0.6 to 4.6%. | |
| Accuracy: In one correlation study, 113 samples with phosphorus | |
| values ranging from 6.1 to 182.4 mg/dL were assayed on the Alfa | |
| Wassermann ACE System (y) and the predicate method (x). Least | |
| squares regression analysis yielded a correlation coefficient of 0.9878, | |
| a standard error estimate of 5.21, a confidence interval slope of 0.960 to | |
| 1.018 and a confidence interval intercept of 1.30 to 5.34. In another | |
| correlation study, 112 samples with phosphorus values ranging from | |
| 5.9 to 175.0 mg/dL were assayed on the Alfa Wassermann ACE Alera | |
| Clinical Chemistry System (y) and the predicate method (x). Least | |
| squares regression analysis yielded a correlation coefficient of 0.9886, | |
| a standard error estimate of 4.89, a confidence interval slope of 0.940 to | |
| 0.995 and a confidence interval intercept of 2.06 to 5.91. In patient | |
| correlation studies at four separate POL sites, using the Alfa | |
| Wassermann ACE reagents and the predicate device (x), least-squares | |
| regression analysis yielded correlation coefficients of 0.9809 to 0.9954, | |
| standard error estimates of 3.88 to 8.40, confidence interval slopes of | |
| 0.885 to 1.030 and confidence interval intercepts of -1.13 to 7.46. | |
| Detection limit: The detection limit was 1.6 mg/dL on the ACE and 1.2 | |
| mg/dL on the ACE Alera Clinical Chemistry Systems. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These |
| data also indicate substantial equivalence to the predicate device. |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like strokes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wasserman Diagnostic Technologies. LLC c/o Hyman Katz, Ph.D. Vice President. Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
- g, 2011
Re: K103615
Trade/Device Name: ACE Urea Nitrogen Reagent, ACE Calcium Arsenazo Reagent, ACE Creatinine Reagent, ACE Inorganic Phosphorus U.V. Reagent, ACE Urine Standard Regulation Number: 21 CFR $862. 1770 Regulation Name: Urease, Photometric, Urea Regulatory Class: Class II Product Code: CDN, CJY, CGX, CEO, JIX Dated: August 23, 2011 Received: August 24, 2011
Dear Dr. Katz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ≤ (03 )6 15
Device Name: ACE Urea Nitrogen Reagent
The ACE Urea Nitrogen Reagent is intended for the quantitative Indications for Use: determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Calcium-Arsenazo Reagent
- The ACE Calcium-Arsenazo Reagent is intended for the Indications for Use: quantitative determination of calcium in urine using the ACE and ACE Alera Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruttle Cheler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1 = 3 6 1 5
Page 1 of 2
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACE Creatinine Reagent
The ACE Creatinine Reagent is intended for the quantitative Indications for Use: determination of creatinine in urine using the ACE and ACE Alera Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Inorganic Phosphorus U.V. Reagent
- Indications for Use: The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Urine Standard
Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Indications for Use: Standard is intended for the calibration of quantitative urine reagents on Alfa Wassermann Clinical Chemistry Systems. For in vitro diagnostic use only.
| Prescription Use X | AND/OR | Over-The-Counter Use. |
|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Buth Charles
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
1 = 2 6 ( 5 510(k)
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