(240 days)
Not Found
No
The device description and performance studies focus on standard chemical reactions and photometric measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic reagent used to quantitatively determine certain substances in serum for diagnostic purposes only, and it is not directly used for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from these reagents are "used in the diagnosis and treatment of numerous diseases." This indicates their role in the diagnostic process.
No
The device description clearly states that the device is a reagent, which is a chemical substance used in a chemical reaction, not a software program. It is intended for use with a clinical chemistry system, which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This test is intended for use in clinical laboratories or physician office laboratories."
- "For in vitro diagnostic use only."
This language clearly indicates that the reagents are designed to be used outside of the body (in vitro) for diagnostic purposes in a clinical setting. The description of the tests (quantitative determination of albumin, total protein, calcium, and inorganic phosphorus in serum) further supports this, as these are common laboratory tests used to aid in the diagnosis and treatment of various medical conditions.
N/A
Intended Use / Indications for Use
The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only
The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. 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 concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). 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 using the ACE Axcel Clinical Chemistry System. 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.
Product codes (comma separated list FDA assigned to the subject device)
CIX, CEK, CJY, CEO
Device Description
In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the 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 sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum 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 sample.
The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.
The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.
The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.
The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy, and detection limit data.
ACE Albumin Reagent
Precision: In testing conducted at four albumin levels for 22 days, the within-run CV ranged from 0.9 to 1.7%, and total CV ranged from 1.2 to 2.0%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.0 to 1.6% and total CV ranged from 0.0 to 2.3%.
Accuracy: In the correlation study, 118 samples with albumin values ranging from 0.4 to 6.4 g/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9959, a standard error estimate of 0.08, a confidence interval slope of 0.980 to 1.013, and a confidence interval intercept of -0.04 to 0.10. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9894 to 0.9966, standard error estimates of 0.08 to 0.13, confidence interval slopes of 0.946 to 1.037, and a confidence interval intercepts of -0.14 to 0.39.
Detection limit: The detection limit was 0.09 g/dL.
ACE Total Protein Reagent
Precision: In testing conducted at four total protein levels for 22 days, the within-run CV ranged from 0.8 to 2.4%, and total CV ranged from 1.0 to 2.9%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.3% and total CV ranged from 0.8 to 1.6%.
Accuracy: In the correlation study, 121 samples with total protein values ranging from 0.4 to 13.5 g/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9977, a standard error estimate of 0.12, a confidence interval slope of 0.978 to 1.002, and a confidence interval intercept of -0.12 to 0.06. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9932 to 0.9987, standard error estimates of 0.09 to 0.24, confidence interval slopes of 0.973 to 1.047, and a confidence interval intercepts of -0.41 to 0.19.
Detection limit: The detection limit was 0.15 g/dL.
ACE Calcium-Arsenazo Reagent
Precision: In testing conducted at four calcium levels for 22 days, the within-run CV ranged from 1.3 to 2.3%, and total CV ranged from 1.4 to 2.3%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 1.4% and total CV ranged from 1.1 to 2.9%.
Accuracy: In the correlation study, 111 samples with calcium values ranging from 0.7 to 14.5 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9935, a standard error estimate of 0.22, a confidence interval slope of 0.998 to 1.042, and a confidence interval intercept of -0.50 to -0.08. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). least-squares regression analysis yielded correlation coefficients of 0.9895 to 0.9977, standard error estimates of 0.16 to 0.23, confidence interval slopes of 0.969 to 1.075, and a confidence interval intercepts of -0.43 to 0.42.
Detection limit: The detection limit was 0.11 mg/dL.
ACE Inorganic Phosphorus U.V. Reagent
Precision: In testing conducted at four phosphorus levels for 22 days, the within-run CV ranged from 1.4 to 1.9%, and total CV ranged from 1.5 to 2.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.6 to 3.2% and total CV ranged from 1.0 to 3.9%.
Accuracy: In the correlation study, 110 samples with phosphorus values ranging from 0.6 to 19.6 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9983, a standard error estimate of 0.16, a confidence interval slope of 0.994 to 1.017, and a confidence interval intercept of -0.06 to 0.05. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9977 to 0.9996, standard error estimates of 0.11 to 0.19, confidence interval slopes of 1.014 to 1.067, and a confidence interval intercepts of -0.33 to 0.09.
Detection limit: The detection limit was 0.07 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
K1B374
510(k) SUMMARY
JUL 1 3 2012
| 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: | July 11, 2012 | | |
| Device: | Trade/Device Name: | ACE Albumin Reagent | |
| | Regulation Number: | 21 C.F.R. § 862.1035 | |
| | Regulation Name: | Albumin Test System | |
| | Regulatory Class: | Class 2 | |
| | Product Code: | CIX | |
| | Common/Classification Name: | Bromcresol Green Dye-Binding,
Albumin | |
| | Trade/Device Name: | ACE Total Protein Reagent | |
| | Regulation Number: | 21 C.F.R. § 862.1635 | |
| | Regulation Name: | Total Protein Test System | |
| | Regulatory Class: | Class 2, Exempt,
meets limits of exemptions per
21 CFR § 862.9 (c)(9) | |
| | Product Code: | CEK | |
| | Common/Classification Name: | Biuret (Colorimetric), Total Protein | |
| | Trade/Device Name: | ACE Calcium-Arsenazo Reagent | |
| | Regulation Number: | 21 C.F.R. § 862.1145 | |
| | Regulation Name: | Calcium Test System | |
| | Regulatory Class: | Class 2 | |
| | Product Code: | CJY | |
| | Common/Classification Name: | Azo Dye, Calcium | |
1
| Trade/Device Name: | ACE Inorganic Phosphorus U.V.
Reagent |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 C.F.R. § 862.1580 |
| Regulation Name: | Phosphorus (Inorganic) Test System |
| Regulatory Class: | Class 1, Reserved |
| Product Code: | CEO |
| Common/Classification Name: | Phosphomolybdate (Colorimetric),
Inorganic Phosphorus |
| Predicate Devices: | Manufacturer for analyzer/reagent system predicate:
Alfa Wassermann ACE plus ISE/Clinical Chemistry System
ACE Reagents (K931786) |
| Device Descriptions: | In the ACE Albumin Reagent assay, Bromcresol green binds specifically to
albumin to form a green colored complex, which is measured
bichromatically at 629 nm/692 nm. The intensity of color produced is
directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide
bonds of proteins under alkaline conditions to form a violet colored
complex which is measured bichromatically at 544 nm/692 nm. The
intensity of color produced is directly proportional to the total protein
concentration in the 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 sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic
conditions, inorganic phosphorus in serum 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 sample. |
| Intended Use: | Indications for Use:
The ACE Albumin Reagent is intended for the quantitative determination of
albumin concentration in serum using the ACE Axcel Clinical Chemistry
System. Albumin measurements are used in the diagnosis and treatment of
numerous diseases involving primarily the liver or kidneys. This test is
intended for use in clinical laboratories or physician office laboratories. For
in vitro diagnostic use only |
.
.
・
:
2
The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. 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 concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). 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 using the ACE Axcel Clinical Chemistry System. 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.
3
| | Technological
Characteristics: | The ACE Albumin Reagent consists of a single reagent bottle. The reagent
contains Bromcresol green and acetate buffer. |
|--|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The ACE Total Protein Reagent consists of a single reagent bottle. The
reagent contains copper sulfate, sodium potassium tartrate, potassium iodide
and sodium hydroxide. |
| | | The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle.
The Reagent contains Arsenazo III. |
| | | The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent
bottle. The reagent contains ammonium molybdate and sulfuric acid. |
| | Performance
Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa
Wassermann ACE Axcel Clinical Chemistry System included precision,
accuracy, and detection limit data. |
| | | ACE Albumin Reagent |
| | | Precision: In testing conducted at four albumin levels for 22 days, the
within-run CV ranged from 0.9 to 1.7%, and total CV ranged from 1.2 to
2.0%. In precision studies at three separate Physician Office Laboratory
(POL) sites over 5 days, the within-run CV ranged from 0.0 to 1.6% and
total CV ranged from 0.0 to 2.3%. |
| | | Accuracy: In the correlation study, 118 samples with albumin values
ranging from 0.4 to 6.4 g/dL were assayed on the Alfa Wassermann ACE
Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE
Clinical Chemistry System (x). Least squares regression analysis yielded a
correlation coefficient of 0.9959, a standard error estimate of 0.08, a
confidence interval slope of 0.980 to 1.013, and a confidence interval
intercept of -0.04 to 0.10. In patient correlation studies at three separate
POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry
System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x),
least-squares regression analysis yielded correlation coefficients of 0.9894
to 0.9966, standard error estimates of 0.08 to 0.13, confidence interval
slopes of 0.946 to 1.037, and a confidence interval intercepts of -0.14 to
0.39.
Detection limit: The detection limit was 0.09 g/dL. |
| | | |
| | | ACE Total Protein Reagent |
| | | Precision: In testing conducted at four total protein levels for 22 days, the
within-run CV ranged from 0.8 to 2.4%, and total CV ranged from 1.0 to
2.9%. In precision studies at three separate Physician Office Laboratory
(POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.3% and
total CV ranged from 0.8 to 1.6%. |
:
1999 - 1999 - 1999
4
Accuracy: In the correlation study, 121 samples with total protein values ranging from 0.4 to 13.5 g/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9977, a standard error estimate of 0.12, a confidence interval slope of 0.978 to 1.002, and a confidence interval intercept of -0.12 to 0.06. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis vielded correlation coefficients of 0.9932 to 0.9987, standard error estimates of 0.09 to 0.24, confidence interval slopes of 0.973 to 1.047, and a confidence interval intercepts of -0.41 to 0.19. .
Detection limit: The detection limit was 0.15 g/dL.
ACE Calcium-Arsenazo Reagent
Precision: In testing conducted at four calcium levels for 22 days, the within-run CV ranged from 1.3 to 2.3%, and total CV ranged from 1.4 to 2.3%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 1.4% and total CV ranged from 1.1 to 2.9%.
Accuracy: In the correlation study, 111 samples with calcium values ranging from 0.7 to 14.5 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9935, a standard error estimate of 0.22, a confidence interval slope of 0.998 to 1.042, and a confidence interval intercept of -0.50 to -0.08. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). least-squares regression analysis yielded correlation coefficients of 0.9895 to 0.9977, standard error estimates of 0.16 to 0.23, confidence interval slopes of 0.969 to 1.075, and a confidence interval intercepts of -0.43 to 0.42.
Detection limit: The detection limit was 0.11 mg/dL.
ACE Inorganic Phosphorus U.V. Reagent
Precision: In testing conducted at four phosphorus levels for 22 days, the within-run CV ranged from 1.4 to 1.9%, and total CV ranged from 1.5 to 2.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.6 to 3.2% and total CV ranged from 1.0 to 3.9%.
5
| | Accuracy: In the correlation study, 110 samples with phosphorus values
ranging from 0.6 to 19.6 mg/dL were assayed on the Alfa Wassermann
ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE
Clinical Chemistry System (x). Least squares regression analysis yielded a
correlation coefficient of 0.9983, a standard error estimate of 0.16, a
confidence interval slope of 0.994 to 1.017, and a confidence interval
intercept of -0.06 to 0.05. In patient correlation studies at three separate
POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry
System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x),
least-squares regression analysis yielded correlation coefficients of 0.9977
to 0.9996, standard error estimates of 0.11 to 0.19, confidence interval
slopes of 1.014 to 1.067, and a confidence interval intercepts of -0.33 to
0.09. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Detection limit: The detection limit was 0.07 mg/dL. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data
also indicate substantial equivalence to the predicate device. |
and the control of the country of the country
:
Career States of Career
. . . . . .
.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, and its head turned to the right. The seal is black and white.
10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph. D. Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
JUL 1 3 2012
Re: K113374
Trade/Device Name: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, ACE Inorganic Phosphorus U.V. Reagent
Regulation Number: 21 CFR§ 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX, CEK, CJY, CEO Dated: May 29, 2012 Received: May 31, 2012
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
8 113374 510(k) Number (if known): __
Device Name: ACE Albumin Reagent
The ACE Albumin Reagent is intended for the quantitative Indications for Use: determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Total Protein Reagent
Indications for Use:
The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. 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)
Rute Chuler
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) 113374
Page 1 of 2
9
Indications for Use
510(k) Number (if known): K113374
Device Name: ACE Calcium-Arsenazo Reagent
Indications for Use: The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular
contractions or spasms). 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 serum using the ACE Axcel Clinical Chemistry System. 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.
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)
Rute C. hulen
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) 113374
Page 2 of 2