ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

K113438 · Alfa Wassermann Diagnostic Technologies, Inc. · JMO · Jun 1, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113438
• Device Name: ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jun 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids. The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

Device consists of three colorimetric reagent assays (TIBC, Serum Iron, Lipase) for use on ACE Axcel Clinical Chemistry System. Reagents are two-part liquid formulations. TIBC assay uses chromazurol B/cetrimide/ferric chloride; Serum Iron uses ferrozine; Lipase uses 1,2-diglyceride substrate with redox-coupled enzymatic reaction. System measures absorbance changes (bichromatic or monochromatic) to determine analyte concentration or activity. Used in clinical/physician office labs by trained personnel. Output is quantitative concentration/activity value. Results assist clinicians in diagnosing anemia, iron-related disorders, and pancreatic conditions.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 and EP10-A3 across multiple sites. Linearity confirmed for TIBC (42-700 μg/dL), Iron (12-600 μg/dL), and Lipase (15-700 U/L). Method comparison against predicate (k931786) using Deming regression showed high correlation (R² > 0.99) for all assays. Interference testing performed for bilirubin, hemolysis, lipemia, and ascorbic acid.

Technological Characteristics

Colorimetric assays. TIBC: chromazurol B/cetrimide/ferric chloride. Serum Iron: ferrozine/hydroxylamine hydrochloride. Lipase: 1,2-diglyceride/monoglyceride lipase/glycerol kinase/glycerol-3-phosphate oxidase/peroxidase. Measurement via ACE Axcel Clinical Chemistry System (bichromatic/monochromatic absorbance). Standards: CLSI EP5-A2, EP6-A, EP7-A2, EP9-A2-IR, EP10-A3, EP17-A.

Indications for Use

Indicated for quantitative determination of total iron-binding capacity, serum iron, and lipase activity in serum for patients requiring diagnosis or treatment of anemia, iron deficiency, hemochromatosis, chronic renal disease, or pancreatic diseases (e.g., pancreatitis, duct obstruction). Intended for use in clinical or physician office laboratories.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• Alfa Wassermann ACE Clinical Chemistry System (K931786)
• ACE Reagents (K000781, K944911)

Submission Summary (Full Text)

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### 510(k) SUMMARY

Alfa Wassermann Diagnostic Technologies, LLC 510(k) Owner: 4 Henderson Drive West Caldwell, NJ 07006 Contact: Hyman Katz, Ph.D. Phone: [phone] Fax: Date Summary March 29, 2012 Updated: Trade Name: ACE Axcel Clinical Chemistry Device: System Classification: Class 1 Common/Classification Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (21 C.F.R. § 862.2610) Product Code JJE Trade Name: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent Classification: Class 1 Common/Classification Name: Direct Total Iron-Binding Capacity (TIBC) (21 C.F.R. § 862.1415) Product Code JMO Trade Name: ACE Serum Iron Reagent Classification: Class 1 Common/Classification Name: Photometric Method, Iron (Non-Heme) (21 C.F.R. § 862.1410) Product Code JIY Trade Name: ACE Lipase Reagent Classification: Class 1 Lipase-Esterase, Enzymatic, Common/Classification Name: Photometric, Lipase (21 C.F.R. § 862.1465)

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| | Product Code CHI |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate | Manufacturer for analyzer/reagent system predicate: |
| Devices: | Alfa Wassermann ACE Clinical Chemistry System (K931786) |
| | ACE Reagents (K000781, K944911) |
| Device<br>Descriptions: | The ACE Axcel Clinical Chemistry System consists of two major<br>components, the chemistry instrument and an integrated Panel PC. The<br>instrument accepts the physical patient samples, performs the<br>appropriate optical or potentiometric measurements on those samples<br>and communicates that data to an integral Panel PC. The Panel PC uses<br>keyboard or touch screen input to manually enter a variety of data,<br>control and accept data from the instrument, manage and maintain<br>system information and generate reports relative to patient status and<br>instrument performance. The Panel PC also allows remote download of<br>patient requisitions and upload of patient results via a standard<br>interface. |
| | In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay,<br>Direct TIBC Color Reagent, an acidic buffer containing an iron-binding<br>dye and ferric chloride, is added to the serum sample. The low pH of<br>Direct TIBC Color Reagent releases iron from transferrin. The iron<br>then forms a colored complex with the dye. The colored complex at the<br>end of the first step represents both the serum iron and excess iron<br>already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a<br>neutral buffer, is then added, shifting the pH and resulting in a large<br>increase in the affinity of transferrin for iron. The serum transferrin<br>rapidly binds the iron by abstracting it from the dye-iron complex. The<br>observed decrease in absorbance of the colored dye-iron complex is<br>directly proportional to the total iron-binding capacity of the serum<br>sample. The absorbance is measured at 647 nm. |
| | In the ACE Serum Iron Reagent assay, transferrin-bound iron in serum<br>is released at an acidic pH and reduced from ferric to ferrous ions.<br>These ions react with ferrozine to form a violet colored complex, which<br>is measured bichromatically at 554 nm/692 nm. The intensity of color<br>produced is directly proportional to the serum iron concentration.<br><br>In the ACE Lipase Reagent Assay, serum lipase acts on a natural<br>substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is<br>hydrolyzed by monoglyceride lipase (a highly specific enzyme for<br>monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts<br>on glycerol to form glycerol-3-phosphate, which is in turn acted on by<br>glycerol-3-phosphate oxidase to generate hydrogen peroxide.<br>Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and<br>TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a<br>quinine dye. The rate of formation of the dye, determined |
| bichromatically at an absorbance of 573 nm/692 nm, is proportional to<br>the lipase activity in the sample. | |
| Intended Use: | Indications for Use: |
| | The ACE Axcel Clinical Chemistry System is an automated, discrete,<br>bench-top, random access analyzer that is intended for <i>in vitro</i><br>diagnostic use in the quantitative determination of constituents in blood<br>and other fluids. |
| | The ACE TIBC Reagent is intended for the quantitative determination<br>of total iron-binding capacity in serum using the ACE Axcel Clinical<br>Chemistry System. Iron-binding capacity measurements are used in the<br>diagnosis and treatment of anemia. This test is intended for use in<br>clinical laboratories or physician office laboratories. For <i>in vitro</i><br>diagnostic use only. |
| | The ACE Serum Iron Reagent is intended for the quantitative<br>determination of iron concentration in serum using the ACE Axcel<br>Clinical Chemistry System. Iron (non-heme) measurements are used in<br>the diagnosis and treatment of diseases such as iron deficiency anemia,<br>hemochromatosis (a disease associated with widespread deposit in the<br>tissues of two iron-containing pigments, hemosiderin and hemofuscin,<br>and characterized by pigmentation of the skin), and chronic renal<br>disease. This test is intended for use in clinical laboratories or physician<br>office laboratories. For <i>in vitro</i> diagnostic use only. |
| | The ACE Lipase Reagent is intended for the quantitative determination<br>of lipase activity in serum using the ACE Axcel Clinical Chemistry<br>System. Lipase measurements are used in diagnosis and treatment of<br>diseases of the pancreas such as acute pancreatitis and obstruction of<br>the pancreatic duct. This test is intended for use in clinical laboratories<br>or physician office laboratories. For <i>in vitro</i> diagnostic use only. |
| Technological<br>Characteristics: | The following is a description of the major features of the ACE Axcel<br>Clinical Chemistry System: |
| | System throughput is approximately 160 test results per hour for<br>routine, single reagent chemistries. System throughput will be<br>higher when the test workload includes ISE's. The instrument has a capacity of 40 reagent containers on board. A reagent cooling system maintains the reagents at 12°C during<br>instrument operation. Reagent containers are identified by computer coded labels to<br>simplify system operation. All reagents in the system must<br>include an identification label on the container. |
| • | Sample and reagent sensing notify the operator of a depleted condition during operation. |
| • | The system performs analysis at a reaction temperature of 37°C. |
| • | An electrolyte subsystem capable of measuring sodium, potassium and chloride concentrations is included. |
| • | Primary draw tubes may be introduced one at a time into the system for closed tube sampling. Positive tube identification can be achieved with an optional barcode scanner. An aliquot volume sufficient for all tests ordered is transferred and stored and the closed tube is returned to the user. |
| • | Sample cups are introduced to the system one at a time or by sample ring segment. |
| • | Disposable cuvettes are loaded in bulk and then automatically injected as needed by a cuvette hopper system. The ACE Axcel Clinical Chemistry System optical system is capable of monitoring a maximum of 48 cuvettes at one time. |
| • | The absorbance optical system is capable of absorbance measurements in a linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen wavelengths are measured simultaneously using a photodiode array. |
| The ACE Direct TIBC Reagent is composed of two reagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBC Color Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride and acetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer. | |
| The ACE Serum Iron Reagent is composed of two reagent bottles (Buffer and Color Reagent). The Buffer (R1) contains: hydroxylamine hydrochloride, acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine and hydroxylamine hydrochloride. | |
| The ACE Lipase Reagent is composed of two reagent bottles (Lipase Reagent and Lipase Activator Reagent). The Lipase Reagent (R1) contains: 1,2-diglyceride, monoglyceride lipase, glycerol kinase, glycerol-3-phosphate oxidase, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine, ATP, peroxidase and cholic acid. The Lipase Activator | |
| Performance<br>Data: | Performance data for the Alfa Wassermann ACE Reagents run on the<br>Alfa Wassermann ACE Axcel Clinical Chemistry System included<br>precision, accuracy and detection limit data. |
| | ACE Direct Total Iron-Binding Capacity (TIBC) Reagent |
| | Precision: In testing conducted at four TIBC levels for 22 days, the<br>within-run CV ranged from 0.9 to 2.2% and total CV ranged from 2.0<br>to 3.3%. In precision studies at three separate Physician Office<br>Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9<br>to 3.4% and total CV ranged from 0.9 to 4.1%. |
| | Accuracy: In the correlation study, 109 samples with TIBC values<br>ranging from 96 to 598 µg/dL were assayed on the Alfa Wassermann<br>ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann<br>ACE Clinical Chemistry System (x). Least squares regression analysis<br>yielded a correlation coefficient of 0.9950, a standard error estimate of<br>9.1, a confidence interval slope of 0.961 to 0.998 and a confidence<br>interval intercept of -9.2 to 4.3. In patient correlation studies at three<br>separate POL sites, using the Alfa Wassermann ACE Axcel Clinical<br>Chemistry System (y) and the Alfa Wassermann ACE Clinical<br>Chemistry System (x), least-squares regression analysis yielded<br>correlation coefficients of 0.9902 to 0.9987, standard error estimates of<br>6.1 to 11.2, confidence interval slopes of 0.923 to 1.006 and confidence<br>interval intercepts of -8.2 to 19.4. |
| | Detection limit: The detection limit was 42.21 µg/dL. |
| | ACE Serum Iron Reagent |
| | Precision: In testing conducted at four Serum Iron levels for 22 days,<br>the within-run CV ranged from 1.2 to 5.2% and total CV ranged from<br>1.3 to 5.4%. In precision studies at three separate Physician Office<br>Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.2<br>to 4.1% and total CV ranged from 1.2 to 4.2%. |
| | Accuracy: In the correlation study, 130 samples with Serum Iron values<br>ranging from 13 to 550 µg/dL were assayed on the Alfa Wassermann<br>ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann<br>ACE Clinical Chemistry System (x). Least squares regression analysis<br>yielded a correlation coefficient of 0.9995, a standard error estimate of<br>3.3, a confidence interval slope of 1.000 to 1.012 and a confidence<br>interval intercept of -2.7 to -1.0. In patient correlation studies at three<br>separate POL sites, using the Alfa Wassermann ACE Axcel Clinical<br>Chemistry System (y) and the Alfa Wassermann ACE Clinical<br>Chemistry System (x), least-squares regression analysis yielded<br>correlation coefficients of 0.9992 to 0.9998, standard error estimates of<br>6.1 to 11.2, confidence interval slopes of 0.997 to 1.041 and confidence |
| | |
| | interval intercepts of -2.7 to 9.2. |
| | Detection limit: The detection limit was 5.08 µg/dL. |
| | ACE Lipase Reagent |
| | Precision: In testing conducted at three lipase levels for 22 days, the<br>within-run CV ranged from 1.1 to 6.5% and total CV ranged from 6.<br>to 10.7%. In precision studies at three separate Physician Office<br>Laboratory (POL) sites over 5 days, the within-run CV ranged from<br>to 7.3% and total CV ranged from 1.9 to 7.3%. |
| | Accuracy: In the correlation study, 107 samples with lipase values<br>ranging from 15.6 to 697.5 U/L were assayed on the Alfa Wassermann<br>ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann<br>ACE Clinical Chemistry System (x). Least squares regression analysis<br>yielded a correlation coefficient of 0.9980, a standard error estimate<br>9.06, a confidence interval slope of 0.970 to 0.994 and a confidence<br>interval intercept of 1.97 to 5.97. In patient correlation studies at three<br>separate POL sites, using the Alfa Wassermann ACE Axcel Clinical<br>Chemistry System (y) and the Alfa Wassermann ACE Clinical<br>Chemistry System (x), least-squares regression analysis yielded<br>correlation coefficients of 0.9993 to 0.9997, standard error estimates<br>4.44 to 7.89, confidence interval slopes of 1.002 to 1.047 and<br>confidence interval intercepts of -4.74 to 3.41. |
| | Detection limit: The detection limit was 10.63 U/L. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These<br>data also indicate substantial equivalence to the predicate device. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

JUN - 1 2012

Alfa Wassermann Diagnostic Technologies. c/o Hyman Katz, Ph. D. Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006

Re: k113438

Trade/Device Name: ACE Direct Total Iron-Binding capacity (TIBC) Reagent, ACE Serum Iron Reagent, ACE Lipase Reagent

Regulation Number: 21 CFR §862.1415 Iron-Binding Capacity Test Regulation Name: Class I, reserved Regulatory Class: Product Code: JMO, JIY, CHI Dated: May 21, 2012 Received: May 23, 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).

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### Page 2

If vou 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 [phone]. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

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

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# Indications for Use

510(k) Number (if known): K113438

Device Name: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent

Indications for Use:

The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Serum Iron Reagent

Indications for Use: The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. 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 Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113435

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# Indications for Use

510(k) Number (if known): _

Device Name: ACE Lipase Reagent

Indications for Use:

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. 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)

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

.510(k) 113438

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