(265 days)
No
The document describes standard imaging cytometry and spectrophotometry techniques for cell counting and hemoglobin measurement. There is no mention of AI or ML algorithms being used for data analysis, image processing, or any other function. The analysis is described as "automated analysis" but this does not inherently imply AI/ML.
No.
The device is used for in vitro diagnostic purposes to enumerate and measure substances in blood, which aids in diagnosis but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The device also performs direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration, which are diagnostic measurements used in managing conditions like HIV.
No
The device is described as a "System" which includes hardware components like an automated multicolor fluorescent imaging cytometer and absorbance spectrometer, in addition to the software. The description also details the physical cartridge and controls, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for both the BD FACSPresto System and the BD FACSPresto CD4/Hb Cartridge & Kit explicitly states: "For in vitro diagnostic use."
- Intended Use: The device is intended to be used with human whole blood to perform direct cell enumeration and measurement of absorbance spectrums for the quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration. These are all measurements performed in vitro (outside the body) on biological specimens to provide information for the diagnosis, monitoring, or treatment of diseases (specifically mentioned for normal and HIV positive patients).
- Components: The system includes reagents (BD FACSPresto CD4/Hb Cartridge & Kit) and controls (BD Multi-Check Control, BD Multi-Check CD4 Low Control, Eurotrol FACSPresto Hb Control) which are typical components of IVD systems used for laboratory testing. The controls are also explicitly stated as being for "in vitro diagnostic use."
- Setting: While not for point-of-care use, the intended use in conjunction with other laboratory and clinical findings implies use in a clinical laboratory setting, which is a common environment for IVD testing.
The device fits the definition of an In Vitro Diagnostic device as it is intended for use in the examination of specimens derived from the human body to provide information for medical purposes.
N/A
Intended Use / Indications for Use
BD FACSPresto System:
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
- For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
- For use in children, adolescents, and adults.
- For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
- Not for point-of-care use.
- For in vitro diagnostic use.
BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit:
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
- For use in children, adolescents, and adults
- For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
- Not for point-of-care use.
- For in vitro diagnostic use.
BD Multi-Check Control:
The BDTM Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
BD Multi-Check CD4 Low Control:
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis.
The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
Eurotrol FACSPresto Hb Control:
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.
Product codes (comma separated list FDA assigned to the subject device)
PMG, OYE, GKL, JPK
Device Description
The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls.
The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting.
The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis.
BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system.
The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area.
Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer.
Anatomical Site
Not Found
Indicated Patient Age Range
children, adolescents, and adults
Intended User / Care Setting
Not for point-of-care use. Prescription Use.
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)
Bench Performance Summary:
- Method Comparison: Based on Method Comparison and Bias Estimation Using Patient Samples, CLSI document EP9-A2-IR. All method comparison results met study acceptance criteria. The BD FACSPresto system provided CD4 and %CD4 results (VP, N = 107 and FS, N = 84) that are substantially equivalent to those generated by the predicate system. The BD FACSPresto system provided Hb results (VP, N = 84 and FS, N = 108) that are substantially equivalent to those generated by the reference system.
- Precision: Based on Evaluation of Precision Performance of Quantitative Measurement, CLSI document EP5-A2. The BD FACSPresto system demonstrates acceptable CV and/or SD results for within-run and total precision for CD4, %CD4, and Hb measured using Streck CD-Chex Plus (Normal and CD4-Low) (N = 168) and Eurotrol FACSPresto Hb Controls (Levels 1-3) (N = 252) on the BD FACSPresto system.
- Linearity: Based on Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, CLSI document EP6-A. The verification test results for the BD FACSPresto system demonstrate acceptable linearity for CD4, Lymphocyte, and Hb ranges (N = 33 for each). The dynamic range of the BD FACSPresto system is established to be linear within 42-4872 CD4 cells/µL. The dynamic range of the BD FACSPresto system is established to be linear within 124-10,713 Lymphocyte cells/µL. The dynamic range of the BD FACSPresto system is established to be linear within 2-26 Hb g/dL.
- Hemoglobin Assay Traceability: Based on Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood, CLSI document H15-A3. This study concludes that the BD FACSPresto system Hb assay is traceable to the HiCN method for hemoglobin determination (N = 4-20 depending on bin). The Hb assay is linear and accurate across the reported linear range (2-20 g/dL) as compared to the HiCN method.
- Analytical Sensitivity: Based on Protocols for Determination of Limits of Detection and Limits of Quantitation, CLSI document EP17-A. From this CD4 evaluation, the LoD is determined to be 22 cells/uL (N = 60) and the LoQ is determined to be 35 cells/uL (N=180). This LoD value is below the system's claimed range for CD4. From this Hb evaluation, the LoD is determined to be 0.91 g/dL (N=300) and the LoQ is determined to be 2 g/dL (N = 60), which supports the claimed range of 2-20 g/dL.
- Interference: Based on Interference Testing in Clinical Chemistry, CLSI document EP7-A2. Of the 34 analytes tested, there was no clinically significant interference at the maximum concentrations tested for 33 of them. One analyte (Gamma Globulin) demonstrated interference at the maximum concentration, but not the mid and low concentrations. None of the analytes caused a bias of > 15% with CD4, %CD4, and Hb assays in the BD FACSPresto Cartridge at the concentrations to be reported.
- Specimen Stability - Age of Blood / Age of Stain: Based on Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens, CLSI document H04-A6. The acceptance criteria were met for all parameters. The Stability Evaluation study supports one (1) hour stain for both venous and capillary blood, and the 22-hour age of blood for venous blood only (N = 70).
- Biocompatibility: Standards include ANSI/AAMI/ISO 10993-5:2009, ASTM F2148:2007, ANSI/AAMI/ISO 10993-10:2010. In the 48-hour titration cytotoxicity / elution test, the test article passed based on reactions observed. The test article met the requirements of the test, since the cultures treated with the extract showed no reactivity. In the murine local lymph node assay, the group treated with the test article elutes showed a Stimulation Index
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
BECTON, DICKINSON AND COMPANY CATHERINE BESSETTE, PHD SR. REGULATORY AFFAIRS SPECIALIST 2350 QUME DRIVE SAN JOSE CA 95131
Re: K150815
Trade/Device Name: BD FACSPresto System
BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels1-3) Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: PMG, OYE, GKL, JPK Dated: November 18, 2015 Received: November 19, 2015
Dear Dr. Bessette:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150815
Device Name BD FACSPresto System BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge Kit
Indications for Use (Describe)
BD FACSPresto System:
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
· For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults.
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.
BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit:
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K150815
Device Name BD Multi-Check Control BD Multi-Check CD4 Low Control
Indications for Use (Describe) BD Multi-Check Control:
The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
BD Multi-Check CD4 Low Control:
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis.
The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K150815
Device Name Eurotrol FACSPresto Hb Control
Indications for Use (Describe)
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Section 5 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.
Date of Summary: November 13, 2015
5.1 Submitted By
BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807 USA
Contact: Catherine Bessette Senior Regulatory Affairs Specialist, Regulatory Affairs (408) 954-4109 Telephone: (408) 954-2347 Fax: Catherine M Bessette@BD.com Email:
5.2 Trade Name/Device Name
| Device Name: | BD FACSPresto™ System |
|---|---|
| BD FACSPresto™ CD4/Hb Cartridge | |
| BD FACSPresto™ CD4/Hb Cartridge Kit | |
| Classification: | Class II |
| Regulation Description: | Automated Differential Cell Counter |
| Regulation Medical Specialty: | Hematology |
| Product Code: | PMG |
Regulation: 21 CFR 864.5220
Device Name: BD Multi-Check Control BD Multi-Check CD4 Low Control Classification: Class II Regulation Description: Hematology Quality Control Mixture Regulation Medical Specialty: Hematology Product Code: JPK Regulation: 21 CFR 864.8625
Device Name: Eurotrol FACSPresto Hb Control (Levels 1-3) Classification: Class II Regulation Description: Hematology Quality Control Mixture Regulation Medical Specialty: Hematology Product Code: JPK Regulation: 21 CFR 864.8625
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5.3 Predicate Device
- BD FACSCalibur™ using BD Tritest CD3/CD4/CD45 with BD Trucount . Tubes and BD MultiSet Software (K071141)
- . R&D Systems' Whole Blood Flow Control, also known as StatusFlow (K961610 & BK990005)
- StatusFlow (K982231) ●
- Eurotrol Hb 301 Control (Levels 1-3) (BK030067) ●
5.4 Reference Device - Sysmex System
Sysmex™ Automated Hematology Analyzer KX-21N (K981761)
5.5 Predicate Device and Reference Device Selection Rationale
The FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes (K071141) was chosen as a predicate since it directly enumerates CD4 and %CD4 on the same specimen types. It is also used to characterize and monitor HIVinfected individuals.
The Sysmex Automated Hematology Analyzer KX-21N (K981761) was chosen as the reference device since it determines hemoglobin concentration on the same specimen type.
StatusFlow and StatusFlow-9 were chosen as a predicate since they are the same reagent composition as the BD branded version of this product, known as BD Multi-Check Control and CD4 Low Control.
Eurotrol Hb 301 Control (Levels 1-3) was chosen as the predicate since they are the same reagent composition as the BD branded version of this product, known as Eurotrol FACSPresto Hb Control (Levels 1-3).
5.6 Basic Description of the Device
The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls.
The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting.
The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-
7
APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis.
BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system.
The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area.
Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.
5.7 Indications for Use
BD FACSPresto System
BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
- For use with the BD FACSPresto™ CD4/Hb Cartridge and BD ● FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
- For use in children, adolescents, and adults. ●
- . For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes.
- Not for point-of-care use. .
- For in vitro diagnostic use. ●
BD FACSPresto CD4/Hb Cartridge
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and
8
determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
- For use in children, adolescents, and adults. .
- For use with human whole blood from fingerstick and/or venous . collections in K2 EDTA or K3 EDTA blood collection tubes.
- Not for point-of-care use. .
- . For in vitro diagnostic use.
BD Multi-Check Control
The BDTM Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
BD Multi-Check CD4 Low Control
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
Eurotrol FACSPresto Hb Control
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System.
The Indications for Use statements are similar to the predicate and reference devices. The differences do not affect the safety and effectiveness of the device relative to the predicate and reference devices.
5.8 Comparison to the Predicate and Reference Devices
Similarities/differences tables are provided for the BD FACSPresto system as compared to the BD FACSCalibur system (Table 5-1) and as compared to the Sysmex system (Table 5-2).
Regarding assay methodology, the BD FACSCalibur system utilizes cytometry through flow, while the BD FACSPresto utilizes cytometry through imaging. Although slightly different technologies, both designs function based on the same
9
principles. Both assay methods use fluorescently labeled antibodies to specifically label cell populations to classify them into sub-populations used for determining lymphocytes/uL and CD4 lymphocytes/uL. In each case, the sample is illuminated with light that excites the fluorescent labels and emitted light passes through optical filters to measure fluorescence intensity for each cell event.
Like flow cytometry, image cytometry is an event threshold or event based method. In both methods, fluorescence intensity is used to determine whether an object is there or not. The distinguishing features between flow and imaging cytometry are merely that (1) in flow, the sample is flowed in front of the detection system in a narrow fluid stream, while in imaging, the sample is static and spread out over the imaging field of view; and (2) flow cytometry includes light scatter intensity as an additional optical parameter. In either case, analysis algorithms are used to convert information about light intensities in different optical channels into cell 'events' and then further classify those events into cell populations of interest such as CD4 positive or negative lymphocytes.
Thus imaging cytometry, similar to flow cytometry, can be defined as the process of extracting and making sense of cytometric data obtained primarily from fluorescence signal intensities of cells specifically labeled with fluorescent antibodies.
| Feature/
Attribute | BD FACSCalibur using BD Tritest
CD3/CD4/CD45 with BD Trucount
Tubes (Predicate Device, K071141) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | • For use with any flow cytometer equipped
with a 488 nm laser and capable of
detection in the ranges: 510-545 nm, 562-
607 nm, and >650 nm
• For use in erythrocyte-lysed whole
peripheral blood
• For use with or without isotype control
• To characterize and monitor some forms
of autoimmune disease
• To characterize and monitor some forms
of immunodeficiency disease, such as in
HIV-infected individuals | BD FACSPresto System is an automated
multicolor fluorescent imaging cytometer
and absorbance spectrometer to be used in
conjunction with single use reagent
cartridges in performing the direct cell
enumeration and measurement of
absorbance spectrums.
• For use with the BD FACSPrestoTM
CD4/Hb Cartridge and BD
FACSPrestoTM CD4/Hb Cartridge Kit
in the direct quantification and
enumeration of CD4 absolute count,
CD4 percentage of lymphocytes, and
determination of hemoglobin
concentration in normal and HIV
positive patients, in conjunction with
other laboratory and clinical findings.
• For use in children, adolescents, and
adults.
• For use with human whole blood from
fingerstick and/or venous collections in
K2 EDTA or K2 EDTA blood collection |
| Feature/
Attribute | BD FACSCalibur using BD Tritest
CD3/CD4/ CD45 with BD Trucount
Tubes (Predicate Device, K071141) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
| | | tubes.
• Not for point-of-care use.
• For in vitro diagnostic use. |
| | | The BD FACSPresto CD4/Hb Cartridge
is a single use reagent cartridge to be used
with the BD FACSPresto™ System for
performing the direct quantification and
enumeration of CD4 absolute count, CD4
percentage of lymphocytes, and
determination of hemoglobin
concentration in normal and HIV positive
patients, in conjunction with other
laboratory and clinical findings. |
| | | • For use in children, adolescents, and
adults.
• For use with human whole blood from
fingerstick and/or venous collections in
K2 EDTA or K3 EDTA blood collection
tubes.
• Not for point-of-care use.
• For in vitro diagnostic use. |
| Device
Classification
and Product
Code | Differential Cell Counter
• Regulation Number:
21 CFR 864.5220
• Product Code: GKZ | Automated Differential Cell Counter
• Regulation Number:
21 CFR 864.5220
• Product Code: PMG |
| Assay
Methodology | Cytometry (flow) | Cytometry (imaging) |
| Assay Menu
(FDA Cleared
Assays) | Absolute CD4 count
%CD4 | Same |
| Results
Reporting | • Absolute CD4 count (cells/uL)
• %CD4 (the percentage of CD4 positive
lymphocytes counted within the total
lymphocyte population count) | Same |
| Sample Type | Whole blood | Same |
| Sample
Volume | Minimum 100 uL whole blood | 1-2 drops venous or capillary whole
blood |
| Sample
Preparation | Manual pipetting for the lyse/wash or
lyse/no-wash methods, or automated with
the BD FACS Sample Prep Assistant (SPA)
for the lyse/no-wash method | Manual introduction of venous or
capillary blood onto BD FACSPresto
Cartridge |
| Sample
Analysis | • A controlled quantity of fluorescent beads
is included in the sample through
preparation in BD TruCount tubes to | • Capillary chamber height is precisely
measured in manufacturing for each
cartridge and encoded in the cartridge
barcode. The size of the analysis image |
| Feature/
Attribute | BD FACSCalibur using BD Tritest
CD3/CD4/ CD45 with BD Trucount
Tubes (Predicate Device, K071141) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
| determine the volume of sample analyzed.
• Fluorescence intensity of beads and of
cells of interest labeled by specific
fluorescent antibodies is quantitatively
measured.
• Cells and fluorescent beads are
algorithmically classified based on these
signal intensities.
• The number of cells in each classification
and the volume of sample analyzed are used
to calculate the reported assay results. | areas is determined by the instrument.
The two are used to calculate the volume
of analyzed sample.
• Fluorescence intensity of cells of
interest labeled by specific fluorescent
antibodies is quantitatively measured.
• Cells are algorithmically classified
based on these signal intensities.
• The number of cells in each
classification and the volume of sample
analyzed are used to calculate the
reported assay results. | |
| Assay
Principles | CD4 and %CD4 flow cytometry assays
using a 3 color direct immunofluorescent
reagent to identify cell subset populations in
lysed blood with automated analysis.
Trucount beads are used for volume
determination. | CD4 and %CD4 imaging cytometry
assays using a 3-color direct
immunofluorescent reagent to identify
cell subset populations in whole blood
with automated analysis. Precise
dimensions of microfluidic channel and
image area are used for volumetric
determination. |
| Optics
Principles -
CD4
and %CD4 | Fluorescence excitation of stained cells in
flow stream by laser illumination;
Fluorescence emission measured by PMTs | Fluorescence excitation of stained cells in
microfluidic channel by LED
illumination;
Fluorescence emission measured by CCD
camera imaging |
| Fluidics | Consists of a pinch valve assembly which
controls the flow of sample, saline sheath
fluid, and waste fluids during data
acquisition. | Cartridge contains a microfluidic channel
through which the sample fills by
capillary action. After filling completes,
sample is static during data acquisition. |
| Instrument
Setup and
Quality
Control | Setup: Semi-automated setup using BD
FACSComp software with BD Calibrite
beads for setting PMT voltages,
fluorescence compensation, and checking
instrument sensitivity. | Setup: Automated instrument setup.
Instrument QC: automated verification of
instrument performance at power-on-self-
test (POST) and during cartridge runs.
Cartridge QC: rat anti-mouse antibodies
bound to polystyrene beads confirm
presence of sample and reagent. |
| Software | Integrated software on instrument and BD
MultiSet Software on external computer | Integrated BD FACSPresto Software |
| Feature/
Attribute | Sysmex Automated Hematology Analyzer
KX-21N (Reference Device, K981761) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
| Intended Use/
Indications for
Use | The intended use of the Sysmex KX-21 is
as an automated cell counter for in vitro
diagnostic use in clinical laboratories. | BD FACSPresto System is an automated
multicolor fluorescent imaging cytometer
and absorbance spectrometer to be used in
conjunction with single use reagent
cartridges in performing the direct cell
enumeration and measurement of
absorbance spectrums.
• For use with the BD FACSPrestoTM
CD4/Hb Cartridge and BD
FACSPrestoTM CD4/Hb Cartridge Kit
in the direct quantification and
enumeration of CD4 absolute count,
CD4 percentage of lymphocytes, and
determination of hemoglobin
concentration in normal and HIV
positive patients, in conjunction with
other laboraotry and clinical findings.
• For use in children, adolescents, and
adults.
• For use with human whole blood from
fingerstick and/or venous collections in
K2 EDTA or K3 EDTA blood collection
tubes.
• Not for point-of-care use.
• For in vitro diagnostic use.
The BD FACSPresto CD4/Hb Cartridge
is a single use reagent cartridge to be used
with the BD FACSPrestoTM System for
performing the direct quantification and
enumeration of CD4 absolute count, CD4
percentage of lymphocytes, and
determination of hemoglobin
concentration in normal and HIV positive
patients, in conjunction with other
laboratory and clinical findings.
• For use in children, adolescents, and
adults.
• For use with human whole blood from
fingerstick and/or venous collections in
K2 EDTA or K3 EDTA blood collection
tubes.
• Not for point-of-care use.
• For in vitro diagnostic use. |
| Feature/
Attribute | Sysmex Automated Hematology Analyzer
KX-21N (Reference Device, K981761) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
| Device
Classification
and Product
Code | Automated Cell Counter (Particle Counter)
• Regulation Number:
21 FR 864.5200
• Product Code: GKL and GKZ | Automated Differential Cell Counter
• Regulation Number:
21 FR 864.5220
• Product Code: PMG |
| Assay
Methodology | Absorbance spectrophotometry | Same |
| Assay Menu
(FDA Cleared
Assays) | Hb determination | Same |
| Results
Reporting | Total Hb concentration | Same |
| Sample Type | Whole blood | Same |
| Sample
Volume | 50 µL whole blood
40 µL pre-dilute | 1-2 drops venous or capillary whole
blood |
| Sample
Preparation | Manual placement of blood tube onto
sample aspiration arm | Manual introduction of venous or
capillary blood onto BD FACSPresto
Cartridge |
| Sample
Analysis | • Narrow-spectrum LED light is directed
through the blood sample to measure light
absorbance at a hemoglobin-absorbing
wavelength.
• Sodium lauryl sulfate lyses the blood cells
in the sample, eliminating light attenuation
caused by scatter.
• Absorbance at the LED wavelength is
used to calculate hemoglobin concentration. | • Broad-spectrum LED light is directed
through the blood sample and a
diffraction grating to create a spectrum
and measure light absorbance at 2
wavelengths: a hemoglobin isosbestic
point and a non-hemoglobin-absorbing
point.
• The light absorbance in the non-
hemoglobin-absorbing region measures
the amount of light attenuation due to
scatter.
• Absorbance at the isosbestic point is
corrected for scatter and used to calculate
hemoglobin concentration. |
| Assay
Principles | Photometric method with reagent that
releases hemoglobin from red cells and
forms a stable colored complex. | Photometric method that detects the
presence of predominant forms of Hb,
with correction for scatter. |
| Optics
Principles - Hb | Absorbance photometric method using
LED-generated monochromatic light and a
photosensor | Absorbance spectrophotometric method
using LED-generated broad spectrum
light, diffraction grating, and CCD sensor |
| Fluidics | A vacuum pump aspirates sample blood,
which passes through a rotor valve and then
to volumetric dispensing, mixing, rinsing,
and draining. Sample is flowing during
data acquisition. | Cartridge contains a microfluidic channel
through which the sample fills by
capillary action. After filling completes,
sample is static during data acquisition. |
| Instrument
Setup and
Quality | Setup: Automated startup check.
Instrument QC: Levey -Jennings control
that uses data from a single analysis of | Setup: Automated instrument setup.
Instrument QC: automated verification of |
| Feature/
Attribute | Sysmex Automated Hematology Analyzer
KX-21N (Reference Device, K981761) | BD FACSPresto System for use with
BD FACSPresto CD4/Hb Cartridge
and BD FACSPresto CD4/Hb
Cartridge Kit (Subject Device) |
| Control | control sample (Sysmex Eight-Check 3WP
X-Tra Controls). | test (POST) and during cartridge runs. |
| Software | Integrated Sysmex Software | Integrated BD FACSPresto Software |
Table 5-1: Similarities/Differences - Predicate Device (BD FACSCalibur system using Tritest) against Subject Device (BD FACSPresto System) for Absolute CD4 Count and %CD4 Assays.
10
11
12
Table 5-2: Similarities/Differences –Reference (Sysmex Automated Hematology Analyzer KX-21N) against Subject Device (BD FACSPresto System) for total Hb assay.
13
14
Table 5-3: Similarities/Differences – Predicate Device (R&D Systems' Whole Blood Flow Control) against Subject Device (BD Multi-Check Control)
| Feature/
Attribute | R&D Systems' Whole Blood Flow
Control (aka StatusFlow)
(Predicate Device, K961610 &
BK990005) | BD Multi-Check Control
(Subject Device) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | R&D Systems' Whole Blood Flow Control
(WBFC) is a stabilized preparation of
human peripheral leukocytes and
erythrocytes to be used as a control in the
complete immunophenotyping process
which includes: antibody staining, RBC
lysis, instrument set-up and instrument
performance. | The BD Multi-Check control is intended
as a complete process control for
immunophenotyping by flow cytometry.
It is a control for antibody staining, red
blood cell (RBC) lysis, instrument setup,
instrument performance, and data
analysis.
The BD Multi-Check control is also
intended as a CD4 and %CD4 process
control for antibody staining, instrument
performance, and data analysis on the BD
FACSPresto system, an imaging
cytometer. |
| Product Code | GKZ | JPK |
| Composition | Human leukocytes and erythrocytes in a
stabilizing medium. | Same |
| Storage
Conditions | 2-8°C | Same |
| Open Vial
Stability | 9 thermal cycles | Same |
| Closed Vial
Stability | 45 days | Same |
15
Table 5-4: Similarities/Differences – Predicate Device (StatusFlow4) against Subject Device (BD Multi-Check CD4 Low Control)
| Feature/
Attribute | StatusFlowLo
(Predicate Device, K982231) | BD Multi-Check CD4 Low Control
(Subject Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | StatusFlowLo is intended as a complete
process control for immunophenotyping by
flow cytometry. It is a control for antibody
staining, RBC lysis, instrument set-up,
instrument performance and data analysis. | The BD Multi-Check CD4 low control
is intended as a complete process control
for immunophenotyping by flow
cytometry. It is a control for antibody
staining, red blood cell (RBC) lysis,
instrument setup, instrument
performance, and data analysis.
The BD Multi-Check CD4 low control is
also intended as a CD4 and %CD4
process control for antibody staining,
instrument performance, and data analysis
on the BD FACSPresto system, an
imaging cytometer. |
| Product Code | GKZ | JPK |
| Composition | Human leukocytes and erythrocytes in a
stabilizing medium. | Same |
| Storage
Conditions | 2-8°C | Same |
| Open Vial
Stability | 9 thermal cycles | Same |
| Closed Vial
Stability | 45 days | Same |
Table 5-5: Similarities/Differences – Predicate Device (Eurotrol Hb 301 Control) against Subject Device (Eurotrol FACSPresto Hb Control)
| Feature/
Attribute | Eurotrol Hb 301 Control
(Predicate Device, BK030067) | Eurotrol FACSPresto Hb Control
(Subject Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The Eurotrol 301 Hb Control is an assayed
hemoglobin control intended for
professional use in the verification of the
precision and accuracy of the HemoCue Hb
301 System. | The Eurotrol FACSPresto Hb Control is
an assayed hemoglobin control intended
for in vitro diagnostic use in the
verification of the precision and
accuracy of the BD FACSPresto
System. |
| Product Code | GGM | JPK |
| Composition | Purified bovine hemolysate | Same |
| Open Vial
Stability | 30 days at 2-30°C | 30 days at 2-8°C |
| Closed Vial
Stability | 25 months at 2-8°C | 1 month at 2-8°C |
16
5.9 Bench and Clinical Performance Data
The following bench performance data (Table 5-6) were provided in support of the substantial equivalence determination.
| Performance
| Characteristic | Standard | Results |
|---|---|---|
| Method | ||
| Comparison | Based on Method | |
| Comparison and Bias | ||
| Estimation Using Patient | ||
| Samples, CLSI document | ||
| EP9-A2-IR. | All method comparison results met study acceptance | |
| criteria. The BD FACSPresto system provided CD4 | ||
| and %CD4 results (VP, N = 107 and FS, N = 84) that | ||
| are substantially equivalent to those generated by the | ||
| predicate system. The BD FACSPresto system | ||
| provided Hb results (VP, N = 84 and FS, N = 108) that | ||
| are substantially equivalent to those generated by the | ||
| reference system. | ||
| Precision | Based on Evaluation of | |
| Precision Performance of | ||
| Quantitative Measurement, | ||
| CLSI document EP5-A2. | The BD FACSPresto system demonstrates acceptable | |
| CV and/or SD results for within-run and total precision | ||
| for CD4, %CD4, and Hb measured using Streck CD- | ||
| Chex Plus (Normal and CD4-Low) (N = 168) and | ||
| Eurotrol FACSPresto Hb Controls (Levels 1-3) (N = |
- on the BD FACSPresto system. |
| Linearity | Based on Evaluation of the
Linearity of Quantitative
Measurement Procedures: A
Statistical Approach, CLSI
document EP6-A. | The verification test results for the BD FACSPresto
system demonstrate acceptable linearity for CD4,
Lymphocyte, and Hb ranges (N = 33 for each).
The dynamic range of the BD FACSPresto system is
established to be linear within $42-4872$ CD4 cells/ $µL$ .
The dynamic range of the BD FACSPresto system is
established to be linear within $124-10,713$ Lymphocyte
cells/ $µL$ .
The dynamic range of the BD FACSPresto system is
established to be linear within $2-26$ Hb g/dL. |
| Hemoglobin
Assay
Traceability | Based on Reference and
Selected Procedures for the
Quantitative Determination
of Hemoglobin in Blood,
CLSI document H15-A3 | This study concludes that the BD FACSPresto system
Hb assay is traceable to the HiCN method for
hemoglobin determination (N = 4-20 depending on
bin). The Hb assay is linear and accurate across the
reported linear range (2-20 g/dL) as compared to the
HiCN method. |
| Analytical
Sensitivity | Based on Protocols for
Determination of Limits of
Detection and Limits of
Quantitation, CLSI document
EP17-A | From this CD4 evaluation, the LoD is determined to be
$22$ cells/ $uL$ (N = 60) and the LoQ is determined to be
$35$ cells/ $uL$ (N=180). This LoD value is below the
system's claimed range for CD4. From this Hb
evaluation, the LoD is determined to be $0.91$ g/dL
(N=300) and the LoQ is determined to be $2$ g/dL (N =
60), which supports the claimed range of 2-20 g/dL. |
Table 5-6: Bench Performance Summary
17
| Performance
| Characteristic | Standard | Results |
|---|---|---|
| Interference | Based on Interference | |
| Testing in Clinical | ||
| Chemistry , CLSI document | ||
| EP7-A2. | Of the 34 analytes tested, there was no clinically | |
| significant interference at the maximum concentrations | ||
| tested for 33 of them. One analyte (Gamma Globulin) | ||
| demonstrated interference at the maximum | ||
| concentration, but not the mid and low concentrations. | ||
| None of the analytes caused a bias of > 15% with CD4, | ||
| %CD4, and Hb assays in the BD FACSPresto | ||
| Cartridge at the concentrations to be reported. | ||
| Specimen | ||
| Stability - Age | ||
| of Blood / Age | ||
| of Stain | Based on Procedures and | |
| Devices for the Collection of | ||
| Diagnostic Capillary Blood | ||
| Specimens , CLSI document | ||
| H04-A6 | The acceptance criteria were met for all parameters. | |
| The Stability Evaluation study supports one (1) hour | ||
| stain for both venous and capillary blood, and the 22- | ||
| hour age of blood for venous blood only (N = 70). | ||
| Biocompatibility | • ANSI/AAMI/ISO 10993- | |
| 5:2009, Biological | ||
| Evaluation of Medical | ||
| Devices-Part 5: Test for in | ||
| vitro cytotoxicity | ||
| • ASTM F2148:2007 – | ||
| Standard Practice for | ||
| Evaluation of Delayed | ||
| Contact hypersensitivity | ||
| using the Murine Local | ||
| Lymph Node Assay | ||
| (LLNA) | ||
| • ANSI/AAMI/ISO 10993- | ||
| 10:2010, Biological | ||
| Evaluation of Medical | ||
| Devices-Part 10: Tests for | ||
| irritation and skin | ||
| sensitization | In the 48-hour titration cytotoxicity / elution test, the | |
| test article passed based on reactions observed. The | ||
| test article met the requirements of the test, since the | ||
| cultures treated with the extract showed no reactivity. | ||
| In the murine local lymph node assay, the group | ||
| treated with the test article elutes showed a Stimulation | ||
| Index |