ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

K113437 · Alfa Wassermann Diagnostic Technologies, Inc. · LCP · Aug 6, 2012 · Hematology

Device Facts

• Record ID: K113437
• Device Name: ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: LCP · Hematology
• Decision Date: Aug 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

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. ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (µmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE Axcel Clinical Chemistry System. The test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only. The ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sites of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

System uses ACE Axcel Clinical Chemistry System to perform quantitative immunoassays on human EDTA whole blood (HbA1c) or serum (T Uptake, T4, Ferritin). HbA1c assay uses latex agglutination inhibition; total hemoglobin measured via alkaline hematin conversion. T Uptake and T4 use homogeneous enzyme immunoassays (CEDIA or G6PD-labeled competition). Ferritin uses latex agglutination turbidimetry. System automates sample pretreatment, reagent mixing, and spectrophotometric absorbance measurement at specific wavelengths (e.g., 592 nm, 340 nm). Results are calculated via calibration curves and reported to clinicians for monitoring diabetes, thyroid function, and iron status. Used in clinical labs and physician office labs by trained personnel. Output aids clinical decision-making regarding disease diagnosis and treatment monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and performance validation of the analytical assays on the ACE Axcel system.

Technological Characteristics

Quantitative immunoassays; latex agglutination (HbA1c, Ferritin) and homogeneous enzyme immunoassay (T Uptake, T4). Reagents include mouse monoclonal antibodies, latex particles, and enzymes (β-galactosidase, G6PD). Analysis performed at 37°C on ACE Axcel Clinical Chemistry System. Calibration via multi-point or linear regression curves. Sterilization not applicable (reagents).

Indications for Use

Indicated for quantitative determination of HbA1c/total hemoglobin (diabetes monitoring), T-uptake (thyroid disorders), total T4 (thyroid diseases), and ferritin (iron metabolism disorders) in human blood/serum. Intended for use in clinical or physician office laboratories.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• Alfa Wassermann ACE Clinical Chemistry System (K931786)
• ACE Reagents (K063306, K981375, K981377, K050944)

Submission Summary (Full Text)

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

1C//3437

# 510(k) SUMMARY

AUG

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] | |
| Date Summary<br>Prepared: | November 18, 2011 | |
| Device: | Trade Name: | ACE Axcel Clinical Chemistry System |
| | Classification: | Class 1 |
| | Common/Classification Name: | Analyzer, Chemistry (Photometric,<br>Discrete), For Clinical Use<br>(21 C.F.R. § 862.2610)<br>Product Code JJE |
| | Trade Name: | ACE Hemoglobin A1c (HbA1c) Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Assay, Glycosylated Hemoglobin<br>(21 C.F.R. § 864.7470)<br>Product Code LCP |
| | Trade Name: | ACE CEDIA T Uptake Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Radioassay, Triiodothyronine Uptake<br>(21 C.F.R. § 862.1715)<br>Product Code KHQ |
| | Trade Name: | ACE T4 Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Enzyme Immunoassay, Non-Radiolabeled,<br>Total Thyroxine<br>(21 C.F.R. § 862.1700)<br>Product Code KLI |
| | Trade Name: | ACE Ferritin Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Ferritin, Antigen, Antiserum, Control<br>(21 C.F.R. § 866.5340)<br>Product Code DBF |
| Predicate<br>Devices: | Manufacturer for analyzer/reagent system predicate:<br>Alfa Wassermann ACE Clinical Chemistry System (K931786)<br>ACE Reagents (K063306, K981375, K981377 and K050944) | |
| Device<br>Descriptions: | The ACE Axcel Clinical Chemistry System consists of two major components,<br>the chemistry instrument and an integrated Panel PC. The instrument accepts<br>the physical patient samples, performs the appropriate optical or potentiometric<br>measurements on those samples and communicates that data to an integral<br>Panel PC. The Panel PC uses keyboard or touch screen input to manually enter<br>a variety of data, control and accept data from the instrument, manage and<br>maintain system information and generate reports relative to patient status and<br>instrument performance. The Panel PC also allows remote download of patient<br>requisitions and upload of patient results via a standard interface.<br><br>Prior to the ACE Hemoglobin A1c (HbA1c) Reagent assay, whole blood<br>samples require a pretreatment step, which is done on-board the analyzer. The<br>red blood cells in the sample are lysed by the Hemoglobin Denaturant and the<br>hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex<br>agglutination inhibition assay is used. In the absence of HbA1c in the sample,<br>the agglutinator (synthetic polymer containing the immunoreactive portion of<br>HbA1c) in the HbA1c Agglutinator Reagent and the antibody-coated<br>microparticles in the HbA1c Antibody Reagent will agglutinate. The presence<br>of HbA1c in the sample competes for the antibody binding sites and inhibits<br>agglutination. The increase in absorbance, monitored monochromatically at<br>592 nm, is inversely proportional to the HbA1c present in the sample. For the<br>determination of total hemoglobin, all hemoglobin derivatives in the sample<br>are converted to alkaline hematin. The reaction produces a green colored<br>solution, which is measured bichromatically at 573 nm/692 nm. The intensity<br>of color produced is directly proportional to the total hemoglobin concentration<br>in the sample. The concentrations of both HbA1c and total hemoglobin are<br>measured, the ratio is calculated and the result reported as percent HbA1c.<br><br>The CEDIA T Uptake assay uses recombinant DNA technology to produce a<br>unique homogeneous enzyme immunoassay system. The assay is based the<br>bacterial enzyme β-galactosidase, which has been genetically engineered into<br>two inactive fragments. These fragments spontaneously re-associate to form<br>fully active enzyme which, in the assay format, cleaves a substrate, generating<br>a color change that can be measured spectrophotometrically. In the assay,<br>enzyme donor thyroxine conjugate binds directly to the unoccupied thyroxine-<br>binding sites in the sample, preventing the spontaneous re-association of the | |
| | enzyme fragments to form the active enzyme. Thus, thyroxine-binding proteins | |
| | regulate the amount of β-galactosidase formed from the reassembly of the | |
| | remaining donor and enzyme acceptor as monitored by the hydrolysis of the | |
| | substrate o-nitrophenyl-β-galactopyranoside.…