(268 days)
No
The summary describes standard flow cytometry principles and software for automated analysis based on predefined algorithms and test definitions, with no mention of AI or ML.
No
The device is an in vitro diagnostic flow cytometer system used for immunophenotyping, which is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications" and is used "for the immunologic assessment of patients having, or suspected of having, immune deficiency." This directly indicates its role in diagnosing medical conditions.
No
The device description clearly states that the system is composed of multiple components including the AQUIOS CL Flow Cytometer (hardware), reagents, and software. While there is software involved, it is part of a larger hardware and reagent system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the AQUIOS CL Flow Cytometer is "intended for use with in vitro diagnostic flow cytometric applications". It also details its use with specific reagents for "immunophenotyping" of peripheral whole blood for the "immunologic assessment of patients having, or suspected of having, immune deficiency." This clearly indicates the device is used to perform tests on biological samples outside of the body to diagnose or assess a medical condition.
- Components: The "Device Description" lists several components that are typical of an IVD system, including reagents (monoclonal antibodies, lysing reagent), controls (Immuno-Trol Cells), and the instrument itself, all designed to work together for diagnostic testing.
- Performance Studies: The "Summary of Performance Studies" describes various tests performed to validate the device's performance for diagnostic purposes, such as linearity, carryover, detection capability, specimen stability, and method comparison against predicate devices. These studies are required for regulatory approval of IVD devices.
- Predicate Devices: The listing of "Predicate Device(s)" with K numbers indicates that this device is being compared to previously cleared IVD devices, which is a common pathway for regulatory submission of new IVDs.
The entire description points to a system designed and intended for use in a clinical laboratory setting to perform diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 mm) laser, two light scatter detection volume (EV). It is used in conjunction with the following reagents and software package.
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent
· Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
• CD45+ absolute count
· CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
· Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
CD45+ absolute count
· CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent -
· Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
CD45+ absolute count
CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent –
· Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
CD45+ absolute count
· CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
Product codes (comma separated list FDA assigned to the subject device)
OYE, JPK, GGK
Device Description
The AQUIOS CL Flow Cytometry System is composed of the following components:
. AQUIOS CL Flow Cytometer
AQUIOS System Software ●
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 ●
AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 ●
AQUIOS Immuno-Trol Cells ●
AQUIOS Immuno-Trol Low Cells ●
. AQUIOS Lysing Reagent Kit
The AQUIOS CL Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.
The AQUIOS System Software is designed for the AQUIOS CL flow cytometer. It includes the algorithms and test definitions that provide automated analysis and results for AQUIOS Tetra-1 and 2+ reagents; this application cannot be modified by the user.
The AQUIOS Flow Cytometry System also offers an optional standalone offline workstation. This workstation is identical to the workstation that is physically connected to the instrument and can be used for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with AQUIOS Tetra-1 and Tetra-2+ reagents and AQUIOS System software according to the product labeling.
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 reagent provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+/CD4+, CD3+/CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+, CD3-/CD19+ and CD3-/CD56+CD16+ lymphocyte percentages and absolute counts in peripheral whole blood. Additionally, both panels provide for CD45+ absolute count and CD45+ Low SS absolute count and percentage.
AQUIOS Immuno-Trol and Immuno-Trol Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
The AQUIOS CL Flow Cytometer uses on-board sample preparation as part of the overall system workflow. The AQUIOS Lysing Reagent Kit is comprised of two ready-to-use reagents: Reagent A lyses the red blood cells, Reagent B quenches the solution, slowing the lyse reaction down in preparation for analysis. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow Cytometry
Anatomical Site
Peripheral whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Fluorescence Linearity: Verify fluorescence detection is linear using standard AQUIOS Tetra settings.
Results: Linearity of fluorescence measurements was demonstrated.
Electronic Volume Linearity: Verify linearity of Electronic Volume measurements at the standard AQUIOS Tetra settings.
Results: Linearity of Electronic Volume measurements was demonstrated.
Laser Performance Characteristics: Verify stability of the laser performance of the AQUIOS CL flow cytometer over time.
Results: Analysis of the data collected demonstrates that the AQUIOS CL laser performance is stable over time.
Analyzer Carryover: To verify carryover for whole blood meets performance specifications.
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets the whole blood carryover performance requirements.
Instrument Settings Stability: Testing to demonstrate stability of the AQUIOS instrument settings to support adequacy of the quality control methodology as an indicator of instrument performance.
Results: Analysis of the data collected demonstrate that the stability of the AQUIOS CL instrument settings support the quality control methodology.
Gravimetrics: Evaluate accuracy and precision of dispensing AQUIOS lysing and antibody reagents, and specimen aspiration/dispense.
Results: Analysis of the data collected demonstrates accuracy and precision of dispensing AQUIOS lysing and antibody reagents, and specimen aspiration/dispense.
Comparability - Collection Tube Performance: Evaluate tube characteristics when used on the AQUIOS system. Study will include verification of the dispensed specimen volumes and minimum required aspiration volumes across the different tube types. Results obtained with the different tube types will be compared at the minimum and maximum number of pierces.
Results: Analysis of the data collected verified the specimen tube recommendations in product labeling.
Assay Linearity: Verify the linear range of the absolute values for each lymphocyte subset populations on the AQUIOS CL Flow Cytometry System.
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets the linearity performance requirements.
Assay Carryover: To verify carryover of whole blood and reagents on the AQUIOS CL meets performance specifications.
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets carryover performance requirements.
Detection Capability: To verify that the AQUIOS CL meets the performance requirements for Limit of Blank (LoB), Lower Limit of Detection (LLoD), Lower Limit of Quantitation (LLoQ).
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets the performance requirements for LoB, LLoD, and LLoQ in whole blood.
Specimen and Prepared Sample Stability: Stability of whole blood samples will be evaluated to verify specimen and prepared sample stability claims.
Results: Analysis of the data collected demonstrates that the AQUIOS CL Flow Cytometry System meets the requirements for specimen and prepared sample stability.
Method Comparison: To evaluate bias between the subject device versus the predicate.
Results: Analysis of the data collected demonstrates that the AQUIOS CL Flow Cytometry System meets the performance requirements when compared to the predicate device.
Precision - Long Term Imprecision: Demonstrate system imprecision using control material as a surrogate for a stabilized sample.
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets performance requirements for Long Term Imprecision.
Precision – Whole Blood Repeatability: Evaluate sample imprecision using a precision profile approach to estimate repeatability at various medical decision levels and data percentiles.
Results: Analysis of the data collected demonstrates that the AQUIOS CL meets performance requirements for Whole Blood Repeatability.
Comparability (Equivalency) – Anticoagulant, Sample Presentation Mode, Open and Closed Vial Sampling Modes, Test Panel Equivalency: Provide data on equivalency of anticoagulants, modes, and panels for use on AQUIOS system.
Results: For all conditions evaluated, the data collected demonstrates that the AQUIOS CL within-method comparisons are equivalent.
Adult Reference Intervals: Establish adult reference intervals for lymphocyte subset analysis on the AQUIOS system.
Results: Adult reference intervals were established and confirmed to be consistent with published values for T, B, and NK lymphocyte subsets.
Stability (AQUIOS Tetra-1 and Tetra-2+): Stability testing will demonstrate the shelf life of the reagents.
Results: Analysis of the data collected demonstrates that the AQUIOS Tetra-1 and Tetra-2+ reagents meet performance requirements in support of the product's stability claims.
Lot Variability (AQUIOS Tetra-1 and Tetra-2+): Variability of multiple lots of material was incorporated into the overall system variability assessed in the clinical testing.
Results: Analysis of the data collected demonstrates that the AQUIOS Tetra-1 and Tetra-2+ have acceptable lot variability performance.
Assay Value Assignment and Expected Ranges (AQUIOS Immuno-Trol and Immuno-Trol Low): Determine the expected ranges (count, percent, separation quotient) for both levels of control as well as the process to assign these values to each lot of material.
Results: Assay value assignment process and expected ranges were established and verified based on analysis of the data collected.
Stability (AQUIOS Immuno-Trol and Immuno-Trol Low): Stability testing will demonstrate the shelf life of the reagents.
Results: Analysis of the data collected demonstrates that the AQUIOS Immuno-Trol and Immuno-Trol Low meet performance requirements in support of the product's stability claims.
Lot Variability (AQUIOS Immuno-Trol and Immuno-Trol Low): Verify lot variability of AQUIOS Immuno-Trol and Immuno-Trol Low.
Results: Analysis of the data collected demonstrates that the AQUIOS Immuno-Trol and Immuno-Trol Low have acceptable lot variability performance.
Stability (AQUIOS Lysing Reagent Kit): Stability testing will demonstrate the shelf life of the reagents.
Results: Analysis of the data collected demonstrates that the AQUIOS Lyse reagents meet performance requirements in support of the product's stability claims.
Lot Variability (AQUIOS Lysing Reagent Kit): Variability of multiple lots of material was incorporated into the overall system variability assessed in the clinical testing.
Results: Analysis of the data collected demonstrates that the AQUIOS Tetra-1 and Tetra-2+ have acceptable lot variability performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K961623, K973483, K974360, K980858, K140911, K984216, K013842
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted in profile, with its head facing right, and its feathers are represented by a series of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
Beckman Coulter, Inc. c/o Mr. Anthony Dennis Staff Regulatory Affairs Specialist 11800 SW 147th Avenue, M/S 31-B06 Miami, FL 33196-2500
Re: K141932
Trade/Device Name: AQUIOS CL Flow Cytometry System AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents AQUIOS Lysing Reagent Kit AQUIOS Immuno-Trol and Immuno-Trol Low Cells Regulation Number: 21 CFR §864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: OYE, JPK, GGK Dated: March 5, 2015 Received: March 9, 2015
Dear Mr. Dennis:
This letter corrects our substantially equivalent letter of April 10, 2015.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809] ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 regulation (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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
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
510(k) Number (if known) K141932
Device Name AQUIOS CL Flow Cytometry System
Indications for Use (Describe)
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 mm) laser, two light scatter detection volume (EV). It is used in conjunction with the following reagents and software package.
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent
· Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
• CD45+ absolute count
-
· CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent -
· Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
-
CD45+ absolute count
-
· CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.
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
3
510(k) Number (if known) K141932
Device Name
AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents
Indications for Use (Describe)
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent
· Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+(ratio only) lymphocyte percentages and absolute
counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X 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
4
510(k) Number (if known) K141932
Device Name AQUIOS Lysing Reagent Kit
Indications for Use (Describe)
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells. Type of
| 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
5
510(k) Number (if known) K141932
Device Name
AQUIOS Immuno-Trol and Immuno-Trol Low Cells
Indications for Use (Describe)
AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow 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
6
510(k) Summary for AQUIOS CL Flow Cytometry System
510(k) Owner / Submitter Information
Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4509 Fax #: (305) 380-4344 Contact Person: Anthony Dennis Email Address: adennis@beckman.com Date Updated: April 9, 2015
Device Information
Trade Name: AOUIOS CL Flow Cytometry System Common Name: AQUIOS CL Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology
Trade Name: AQUIOS Tetra-1 and Tetra-2+ Monoclonal Antibody Reagents Common Name: AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: OYE Panel: Hematology
Trade Name: AOUIOS Lysing Reagent Kit
Common Name: AQUIOS Lysing Reagent Kit Classification Name: Red cell lysing reagent (21 CFR 864.8540), Automated differential cell counter (21 CFR 864.5220) Classification: Class I Non-Exempt [due to limitations of the exemptions of 21 CFR 864.9(c)(1) and (c)(3)] Product Code: GGK, OYE [as used as part of the AQUIOS flow cytometry system] Panel: Hematology
Trade Name: AOUIOS Immuno-Trol and Immuno-Trol Low Cells Common Name: AOUIOS Immuno-Trol and Immuno-Trol Low Classification Name: Hematology quality control mixture (21 CFR 864.8625) Classification: Class II Product Code: JPK Panel: Hematology
7
Predicate Device Information
| Predicate Product | 510(k)
Number | Date
Cleared | Classification | 21 CFR | Product
Code |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------|----------------|----------|-----------------|
| CaliBRITE 3 Color and
FACSComp | K961623 | 6/07/96 | Class II | 864.5220 | GKZ |
| CaliBRITE APC beads CaliBRITE
4 kit (unlabeled, FITC-, PE-,
PerCP- and APC- labeled
CaliBRITE beads), and
FACSComp software
(FACSCalibur) | K973483 | 2/17/98 | Class II | 864.5220 | GKZ |
| MultiTEST CD3/CD8/CD45/CD4 | K974360 | 03/11/98 | Class II | 864.5220 | GKZ |
| Multitest
CD3/CD16+56/CD45/CD19
Reagent and Multitest IMK Kit
Lysing Solution with BD TruCount
Tubes | K980858 | 5/22/98 | Class II | 864.5220 | GKZ |
| Unicel DxH 800 | K140911 | 09/05/14 | Class II | 864.5220 | GKZ |
| Immuno-Trol Control Cells | K984216 | 03/16/99 | Class II | 864.8625 | JPK |
| Immuno-Trol Low Cells | K013842 | 12/13/01 | Class II | 864.8625 | JPK |
Device Description
The AQUIOS CL Flow Cytometry System is composed of the following components:
- . AQUIOS CL Flow Cytometer
- AQUIOS System Software ●
- AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 ●
- AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 ●
- AQUIOS Immuno-Trol Cells ●
- AQUIOS Immuno-Trol Low Cells ●
- . AQUIOS Lysing Reagent Kit
The AQUIOS CL Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells
8
and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.
The AQUIOS System Software is designed for the AQUIOS CL flow cytometer. It includes the algorithms and test definitions that provide automated analysis and results for AQUIOS Tetra-1 and 2+ reagents; this application cannot be modified by the user.
The AQUIOS Flow Cytometry System also offers an optional standalone offline workstation. This workstation is identical to the workstation that is physically connected to the instrument and can be used for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with AQUIOS Tetra-1 and Tetra-2+ reagents and AQUIOS System software according to the product labeling.
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 reagent provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+/CD4+, CD3+/CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+, CD3-/CD19+ and CD3-/CD56+CD16+ lymphocyte percentages and absolute counts in peripheral whole blood. Additionally, both panels provide for CD45+ absolute count and CD45+ Low SS absolute count and percentage.
AQUIOS Immuno-Trol and Immuno-Trol Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
The AQUIOS CL Flow Cytometer uses on-board sample preparation as part of the overall system workflow. The AQUIOS Lysing Reagent Kit is comprised of two readyto-use reagents: Reagent A lyses the red blood cells, Reagent B quenches the solution, slowing the lyse reaction down in preparation for analysis. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.
Intended Use:
AQUIOS CL Flow Cytometry System Indications for Use:
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package.
9
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiencv. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
- CD45+ absolute count
- CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent –
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.
AQUIOS Tetra-1 and Tetra-2 Indications for Use:
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
- CD45+ absolute count
- CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent -
- · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
- CD45+ absolute count
- · CD45+ Low SS (lymphocytes) percentage and absolute count
10
AQUIOS Immuno-Trol and Immuno-Trol Low Cells Indications for Use:
AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AOUIOS CL Flow Cytometer.
AQUIOS Lysing Reagent Kit:
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
11
Technological Characteristics Comparisons to Predicate
AQUIOS CL Flow Cytometer Device Comparison Tables:
| Similarities | ||||
|---|---|---|---|---|
| Predicate | Device | |||
| FACSCalibur | ||||
| Characteristic | CaliBRITE APC beads CaliBRITE 4 | |||
| kit (unlabeled, FITC-, PE-, PE-, PerCP- | ||||
| and APC- labeled CaliBRITE beads), | ||||
| and FACSComp software | CaliBRITE 3 Color and FACSComp | AQUIOS CL Flow Cytometer | ||
| Intended Use* | For flow cytometer set up and | For flow cytometer set up and | The AQUIOS CL Flow Cytometer is | |
| monitoring of instrument | monitoring of instrument | intended for use with in vitro diagnostic | ||
| performance prior to performing | performance. | flow cytometric applications using up to | ||
| reticulocyte enumeration or | four fluorescent detection channels using | |||
| immunophenotyping applications. | a blue (488 nm) laser, two light scatter | |||
| Flow cytometry has been found | detection channels and electronic | |||
| useful in monitoring some forms of | volume (EV). It is used in conjunction | |||
| immune disease. | with the following reagents and software | |||
| package. | ||||
| AQUIOS Tetra-1 Panel and AQUIOS | ||||
| Tetra-2+ Panel monoclonal antibody | ||||
| reagents are for use on the AQUIOS CL | ||||
| Flow Cytometer with peripheral whole | ||||
| * Only similar parameters of both | blood for immunophenotyping. These | |||
| devices are presented here. Refer to | reagents are indicated for use in the | |||
| DxH 800 SE table for other | immunologic assessment of patients | |||
| parameters. | having, or suspected of having, immune | |||
| deficiency. These reagents provide | ||||
| Similarities | ||||
| Characteristic | Predicate | |||
| FACSCalibur | Device | |||
| CaliBRITE 3 Color and FACSComp | AQUIOS CL Flow Cytometer | |||
| identification and enumeration of; | ||||
| CaliBRITE APC beads CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC- labeled CaliBRITE beads), and FACSComp software | - AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent Total CD3+, | |||
| CD3+CD4+,CD3+CD8+, | ||||
| CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts. - AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent Total CD3+, CD3-CD19+, | ||||
| CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off- | ||||
| Similarities | ||||
| Predicate | ||||
| FACSCalibur | Device | |||
| Characteristic | CaliBRITE APC beads CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC- labeled CaliBRITE beads), and FACSComp software | CaliBRITE 3 Color and FACSComp | AQUIOS CL Flow Cytometer | |
| line analysis must be performed in accordance with the product labeling. | ||||
| Device Classification | Class II | |||
| 864.5220 | Same | |||
| Sample Analysis | Principle of analysis – Flow cytometricDetection hardware – Lasers, fluidics, optics, electronicsSample analysis pathway | Same | ||
| Optics | Laser light delivered by mirrors, prisms, and lenses | |||
| Emitted light delivered by mirrors | Same | |||
| Software functionality to allow – | ||||
| Workstation | Patient data management – storage, review, reporting to LISControl data management – storage, review, reportingSystem configuration managementSystem service test and adjustment procedures | Same | ||
| Differences | ||||
| Characteristic | Predicate | |||
| FACSCalibur | CaliBRITE 3 Color and | |||
| FACSComp | Device | |||
| Characteristic | CaliBRITE APC beads | |||
| CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC-labeled CaliBRITE beads), and | ||||
| FACSComp software | AQUIOS CL Flow Cytometer | |||
| Product Code | GKZ | OYE | ||
| System | ||||
| Configuration | BD FACSCalibur with FACS Loader Option and BD FACStation™ Mac Pro | |||
| computer and Cell Quest SW | AQUIOS System with Reagent Cart and | |||
| All-in-One Touch Screen Computer | ||||
| loaded with AQUIOS System Software, | ||||
| Database, and Tetra Tests (Tetra 1, Tetra | ||||
| 2, and Tetra Combo) | ||||
| Operating | ||||
| System | MAC OS 9 | Microsoft Windows 7 | ||
| Controlling | ||||
| software | FACSComp | AQUIOS System Software | ||
| Lasers | Blue - 488 nm argon ion | |||
| Red - 635 nm diode laser | Blue - 488 nm Blue Laser (20mW) | |||
| Sample | ||||
| Preparation | Manual | Automated On-board | ||
| Lyse Timing | 15 minute incubation in the dark at room temperature. | Less than or equal to 3 minutes in the | ||
| dark at room temperature | ||||
| Lyse Reagents | BD FACS lysing solution | AQUIOS Lysing Reagent Kit | ||
| Monoclonal | ||||
| Antibody | ||||
| Assay | BD Trucount tubes | |||
| Two tube antibody reagent assay: | ||||
| CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC | Two tube monoclonal antibody reagent | |||
| assay: | ||||
| o CD45-FITC/CD4-RD1/CD8- | ||||
| Differences | ||||
| Predicate | ||||
| FACSCalibur | Device | |||
| Characteristic | CaliBRITE APC beads | |||
| CaliBRITE 4 kit (unlabeled, | ||||
| FITC-, PE-, PerCP- and APC- | ||||
| labeled CaliBRITE beads), and | ||||
| FACSComp software | CaliBRITE 3 Color and | |||
| FACSComp | AQUIOS CL Flow Cytometer | |||
| ◦ CD3-FITC/CD16-PE+CD56-PE/CD45-PerCP/CD19-APC | ECD/CD3-PC5 | |||
| ◦ CD45-FITC/CD56+CD16- | ||||
| RD1/CD19-ECD/CD3-PC5 | ||||
| Specimen | ||||
| Introduction | N/A | Specimens are loaded in the Autoloader | ||
| using cassettes / or the single loader as | ||||
| single specimen tubes | ||||
| Prepared | ||||
| Sample | ||||
| Introduction | FACS Loader (K953302) | 96 well plate | ||
| Specimen | ||||
| Identification | Manual entry into Worklist | Barcode - positive sample identification | ||
| or manual entry | ||||
| Prepared | ||||
| Sample | ||||
| Identification | Worklist and Carousel position | Software tracked by well position. | ||
| Standardization | Automatic voltage/gain adjustments Compensation matrix calculation | A standardization check is performed on | ||
| each control run | ||||
| Sample | ||||
| Analysis | Manual gating of cellular populations per instrument IFU or automated gating | |||
| of cellular populations with BD Multiset software | Automated gating of cellular population | |||
| by AQUIOS System Software. The | ||||
| software only allows region | ||||
| readjustments by the user | ||||
| Count Method | Cellular events are compared to bead events. | Automated method: Absolute counts are determined by MultiSETTM software. | ||
| Manual data analysis using software such as CellQuestTM, absolute counts are | Syringe based volumetric method using | |||
| AQUIOS System Software | ||||
| Differences | ||||
| Predicate | ||||
| FACSCalibur | Device | |||
| Characteristic | CaliBRITE APC beads | |||
| CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC-labeled CaliBRITE beads), and | ||||
| FACSComp software | AQUIOS CL Flow Cytometer | |||
| determined by division of the number of positive cellular events by the | ||||
| number of bead events multiplied by the TruCOUNT bead concentration. | ||||
| Photomultipler | ||||
| Tubes (PMTs) / | ||||
| Colors | FSC Diode | |||
| SSC 488/10 | ||||
| 4 FL Detectors: | ||||
| • FL1 530/30 nm | ||||
| • FL2 585/42 nm | ||||
| • FL3 670 (LP) nm | ||||
| • FL4 661/16 nm | FS Solid State Detector | |||
| SS Solid State Detector – (488LP Dichroic) | ||||
| 4 FL Detectors: | ||||
| • 525nm BP Filter | ||||
| • 575nm BP Filter | ||||
| • 620nm BP Filter | ||||
| • 675nm BP Filter | ||||
| Detectors/ | ||||
| Parameters | Six (FS, SS, FL1-FL4) | Seven (EV, FS, SS, FL1 – FL4) | ||
| Off-line | ||||
| analysis | ||||
| software | BD Multiset and BD Cell Quest Pro | Stand-alone workstations with AQUIOS | ||
| System Software to review data offline | ||||
| Similarities | ||||
| Characteristic | Predicate | Device | ||
| MultiTEST | ||||
| CD3/CD8/CD45/CD4 | Multitest | |||
| CD3/CD16+56/CD45/CD19 | ||||
| Reagent and Multitest IMK Kit | ||||
| Lysing Solution with BD | ||||
| TruCount Tubes (PREDICATE) | AQUIOS Tetra-1 and AQUIOS Tetra-2+ | |||
| Intended Use* | The BD Multitest IMK kit is a four-color direct | |||
| immunofluorescence reagent kit for use with a suitably equipped | ||||
| flow cytometer to identify and determine the percentages and | ||||
| absolute counts of the following mature human lymphocyte | ||||
| subsets in erythrocyte-lysed whole blood: T lymphocytes | ||||
| (CD3+), B lymphocytes (CD19+), helper/inducer T lymphocytes | ||||
| (CD3+CD4+), suppressor/cytotoxic T lymphocytes | ||||
| (CD3+CD8+), and natural killer (NK) lymphocytes (CD3-CD16+ | ||||
| and/or CD56+). BD Trucount tubes are used for determining | ||||
| absolute counts. BD Multitest reagents and BD Trucount tubes | ||||
| can be used with the BD FACS Loader. |
- Only similar parameters of both devices are presented here.
Refer to DxH 800 SE table for other parameters. | | AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel
monoclonal antibody reagents are for use on the
AQUIOS CL Flow Cytometer with peripheral whole
blood for immunophenotyping. These reagents are
indicated for use in the immunologic assessment of
patients having, or suspected of having, immune
deficiency. These reagents provide identification and
enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody
Reagent
• Total CD3+, CD3+CD4+,CD3+CD8+,
CD3+CD4+/CD3+CD8+ (ratio only)
lymphocyte percentages and absolute
counts. - AQUIOS Tetra-2+ Panel Monoclonal
Antibody Reagent
• Total CD3+, CD3-CD19+, CD3-CD56+ | |
| Similarities | | | | |
| | Predicate | | Device | |
| Characteristic | MultiTEST
CD3/CD8/CD45/CD4 | Multitest
CD3/CD16+56/CD45/CD19
Reagent and Multitest IMK Kit
Lysing Solution with BD
TruCount Tubes (PREDICATE) | AQUIOS Tetra-1 and AQUIOS Tetra-2+ | |
| Device
Classification | Class II | | Same | |
| Reagent Assay | BD Multitest
CD3/CD8/CD45/CD4
reagent provided in 1 ml of
buffered saline with 0.1%
sodium azide | BD Multitest
CD3/CD16+CD56/CD45/CD19
reagent provided in 1 ml of
buffered saline with 0.1% sodium
azide | Two test monoclonal antibody reagent assay:
o CD45/CD4/CD8/CD3
o CD45/CD56+CD16/CD19/CD3 | |
12
13
14
15
510(k) Submission for AQUIOS CL Flow Cytometry System Section 5: 510(k) Summary
16
17
AQUIOS Tetra-1 and Tetra-2+ Device Comparison Tables:
18
19
| Differences | |||
|---|---|---|---|
| Predicate | Device | ||
| Characteristic | MultiTEST | ||
| CD3/CD8/CD45/CD4 | Multitest | ||
| CD3/CD16+56/CD45/CD19 | |||
| Reagent and Multitest IMK Kit | |||
| Lysing Solution with BD | |||
| TruCount Tubes (PREDICATE) | AQUIOS Tetra 1 and AQUIOS Tetra-2+ | ||
| Product Code | GKZ | OYE | |
| Instrument | |||
| Quality Control | |||
| Techniques | BD Multi-Check control, BD Multi-Check CD4 Low control and | ||
| CaliBRITE Beads | AQUIOS Immuno-Trol and AQUIOS Immuno-Trol | ||
| Low | |||
| Antibody | |||
| Incubation | |||
| Time | 15 minutes in the dark at room temperature | 15-45 minutes in the dark at room temperature |
20
| Similarities | |||
|---|---|---|---|
| Characteristic | Predicate | ||
| UniCel DxH 800 | Device | ||
| AQUIOS Tetra 1 and AQUIOS Tetra-2+ | |||
| Intended Use* | The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. |
The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types:
Whole Blood (Venous) WBC, LY%, LY# * Only similar parameters of both devices are presented here | AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of ;
AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent CD45+ absolute count CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent CD45+ absolute count CD45+ Low SS (lymphocytes) percentage and absolute count | |
| Device
Classification | Class II | Same | |
| Specimen Age
Claim | 24 hours room temperature | Same | |
| Similarities | | | |
| Characteristic | Predicate
UniCel DxH 800 | Device
AQUIOS Tetra 1 and AQUIOS Tetra-2+ | |
| Sample
Preparation | Whole blood sample diluted with reagents | Same | |
| Quality Control
Techniques | Daily Instrument Checks
Commercial Controls
Inter-laboratory Quality Assurance Program (IQAP) | Daily Instrument Checks
Commercial Controls
Inter-laboratory Quality Assurance Program (IQAP) | |
| Sampling
Mechanism | Single aspiration probe used for all sampling.
Single-tube presentation – open and closed vial sampling – specimen manually mixed
Automated presentation – closed vial sampling from five-position cassette accepting a variety of defined specimen tubes. Cassette containing specimens mixed prior to starting sampling and between specimens. | Same | |
| Mechanisms
for Processing | Mechanisms to achieve process of :
- automated cassette transportation and specimen mixing (by rocking)
- sample aspiration
- sample preparation
- sample and reagent presentation to analytical modules
- sample analysis
- raw data collection
- algorithmic processing
- data reporting | Same | |
| Differences | | | |
| Characteristic | Predicate | Device | |
| Intended Use | The UniCel® DxH 800 Analyzer is a quantitative multi-
parameter, automated hematology analyzer for in vitro
diagnostic use in screening patient populations found in
clinical laboratories.
The UniCel® DxH 800 Analyzer identifies and enumerates
the parameters indicated below on the following sample
types:
Whole Blood (Venous and Capillary) RBC, HGB, HCT, MCV, MCH, MCHC, RDW,
RDW-SD, PLT, MPV, NE%, NE#, MO%,
MO#, EO%, EO#, BA%, BA#, NRBC%,
NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) WBC, RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) TNC and RBC | AQUIOS Tetra-1 and AQUIOS Tetra-2+
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel
monoclonal antibody reagents are for use on the
AQUIOS CL Flow Cytometer with peripheral whole
blood. These reagents are indicated for use in the
immunologic assessment of patients having, or suspected
of having, immune deficiency. These reagents provide
identification and enumeration of;
AQUIOS Tetra-1 Panel Monoclonal Antibody
Reagent Total CD3+, CD3+CD4+,CD3+CD8+,
CD3+CD4+/CD3+CD8+ (ratio only)
lymphocyte percentages and absolute counts. AQUIOS Tetra-2+ Panel Monoclonal Antibody
Reagent percentage and absolute count Total CD3+, CD3-CD19+, CD3-CD56+
and/or CD16+ lymphocyte percentages and
absolute counts. AQUIOS Flow Cytometry Software may be run on an
independent computer workstation for off-line analysis
of results generated by the AQUIOS CL Flow Cytometer
with the monoclonal antibody reagents listed above. The
off-line analysis must be performed in accordance with
the product labeling. | |
| Differences | | | |
| | Predicate | Device | |
| Characteristic | UniCel DxH 800 | AQUIOS Tetra-1 and AQUIOS Tetra-2+ | |
| Product Code | GKZ | OYE | |
| Specimen Age
Claim | 48 hours refrigerated | Should not be refrigerated. | |
| WBC, RBC,
MCV, Plt, TNC | Aperture impedance (Coulter® Principle) | Aperture impedance (Coulter® Principle) and flow
cytometry analysis | |
| Performance
Characteristics | Quantitative test for RBC, HGB, HCT, MCV, MCHC,
RDW, RDW-SD, PLT, MPV, NE%, NE#, MO%, MO#,
EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#,
MRV, IRF, TNC | Total CD3+, CD3+CD4+,CD3+CD8+,
CD3+CD4+/CD3+CD8+ (ratio only),
CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte
percentages and absolute counts. | |
| Reagents to
determine
Lymphocytes | Coulter® DxH Diluent
Coulter® DxH Diff Pack | AQUIOS Tetra-1 - CD45-FITC, B3821F4A; CD4-RD1,
SFCI12T4D11; CD8-ECD, SFCI21Thy2D3; CD3-PC5,
UCHT1
AQUIOS Tetra-2+ - CD45-FITC, B3821F4A; CD3-PC5,
UCHT1; CD56+CD16-RD1, N901/NKH-1;CD19-ECD,
J3-119
AQUIOS Lysing Reagent Kit
AQUIOS Sheath | |
| Reagents to
determine WBC | Coulter® DxH Diff Pack
Coulter® DxH Cell Lyse | AQUIOS Tetra-1 - CD45-FITC, B3821F4A; CD4-RD1,
SFCI12T4D11; CD8-ECD, SFCI21Thy2D3; CD3-PC5,
UCHT1
AQUIOS Tetra-2+ - CD45-FITC, B3821F4A; CD3-PC5,
UCHT1; CD56+CD16-RD1, N901/NKH-1;CD19-ECD,
13-119
AQUIOS Lysing Reagent Kit
AQUIOS Sheath | |
| Controls | Coulter® 6C Cell Control | AQUIOS Immuno-Trol Cells | |
| Calibrators | Coulter® Latron™ CP-X Control
Coulter® S-CAL® Calibrator Kit | AQUIOS Immuno-Trol Low Cells
Factory/Service calibrated | |
| Similarities | | | |
| | Predicate | Device | |
| Characteristic | Immuno-Trol Control Cells
(Predicate) | Immuno-Trol Low Cells
(Predicate) | AQUIOS Immuno-Trol and Immuno-
Trol Low |
| Intended Use | IMMUNO-TROL™ Control Cells
(Immuno-Trol) is an assayed,
lysable whole blood quality
control product for
immunophenotyping analysis
using monoclonal antibody
reagents and flow cytometry. It
provides a positive cell control
that is processed in the same
manner as a whole blood sample.
This allows verification of reagent
performance and the methods
used for staining targeted cells,
lysing erythrocytes, and analyzing
samples by flow cytometry. | IMMUNO-TROL™ Low Cells is an
assayed, lysable whole blood quality
control product for
immunophenotyping analysis using
monoclonal antibody reagents and
flow cytometry. It provides a positive
cell control that is processed in the
same manner as a whole blood
sample. | AQUIOS Immuno-Trol
AQUIOS IMMUNO-TROL™ Cells are
assayed, lysable whole blood quality
control product for immunophenotyping
analysis using monoclonal antibody
reagents and flow cytometry. It provides a
positive cell control that is processed in the
same manner as a whole blood sample.
This allows verification of instrument and
reagent performance. It also verifies the
methods used for staining targeted cells,
lysing erythrocytes, and analyzing samples
by the AQUIOS CL Flow Cytometer.
AQUIOS Immuno-Trol Low
AQUIOS IMMUNO-TROL™ Low Cells
are assayed, lysable whole blood quality
control product for immunophenotyping
analysis using monoclonal antibody
reagents and flow cytometry. It provides a
|
21
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23
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510(k) Submission for AQUIOS CL Flow Cytometry System Section 5: 510(k) Summary
25
| Similarities | |||
|---|---|---|---|
| Predicate | Device | ||
| Characteristic | Immuno-Trol Control Cells | ||
| (Predicate) | Immuno-Trol Low Cells | ||
| (Predicate) | AQUIOS Immuno-Trol and Immuno-Trol Low | ||
| Device | |||
| Classification | |||
| and Product | |||
| Code | Class II, JPK | Same |
| Differences | ||
|---|---|---|
| Characteristic | Predicate | Device |
| Immuno-Trol Control Cells | ||
| (Predicate) | AQUIOS Immuno-Trol and Immuno-Trol Low | |
| Immuno-Trol Low Cells | ||
| (Predicate) | ||
| Assay | ||
| Parameters | CD3+ count, % | Same except with the addition of; |
| CD3+/CD4+ count, % | CD3-/(CD56+16)+ count, % | |
| CD3+/CD8+ count, % | CD45+ count | |
| CD3-/CD56+ count, % | CD45+ Low SS count, % | |
| CD19+ count, % | CD3 Separation Quotient | |
| CD4 Separation Quotient | ||
| CD8 Separation Quotient | ||
| CD56+16 Separation Quotient | ||
| CD19 Separation Quotient | ||
| CD45 Lymph/High SS Cells Separation | ||
| Quotient | ||
| SS Lymph/High SS Cells Separation | ||
| Quotient | ||
| FS Lymph/High SS Separation Quotient |
26
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluorescence
Linearity | Verify fluorescence
detection is linear using
standard AQUIOS Tetra
settings. | None | None | Linearity of fluorescence measurements
was demonstrated. |
| Electronic
Volume
Linearity | Verify linearity of
Electronic Volume
measurements at the
standard AQUIOS Tetra
settings. | None | None | Linearity of Electronic Volume
measurements was demonstrated. |
| Laser
Performance
Characteristics | Verify stability of the
laser performance of the
AQUIOS CL flow
cytometer over time. | None | None | Analysis of the data collected
demonstrates that the AQUIOS CL laser
performance is stable over time. |
| Analyzer
Carryover | To verify carryover for
whole blood meets
performance
specifications. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Carryover
(Section 12) | CLSI H26-A2; FDA Standards
Recognition #7-210 | Analysis of the data collected
demonstrates that the AQUIOS CL
meets the whole blood carryover
performance requirements. |
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
| Instrument
Settings Stability | Testing to demonstrate
stability of the AQUIOS
instrument settings to
support adequacy of the
quality control
methodology as an
indicator of instrument
performance. | None | None | Analysis of the data collected
demonstrate that the stability of the
AQUIOS CL instrument settings
support the quality control
methodology. |
| Gravimetrics | Evaluate accuracy and
precision of dispensing
AQUIOS lysing and
antibody reagents, and
specimen
aspiration/dispense. | None | None | Analysis of the data collected
demonstrates accuracy and precision of
dispensing AQUIOS lysing and
antibody reagents, and specimen
aspiration/dispense. |
| Comparability -
Collection Tube
Performance | Evaluate tube
characteristics when used
on the AQUIOS system.
Study will include
verification of the
dispensed specimen
volumes and minimum
required aspiration
volumes across the
different tube types.
Results obtained with the
different tube types will
be compared at the
minimum and maximum
number of pierces. | None | CLSI EP15-A2, User
Verification of Performance
for Precision and Trueness;
Approved Guideline – Second
Edition. (FDA Recognition
Number 7-153) | Analysis of the data collected verified
the specimen tube recommendations in
product labeling. |
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
| Assay Linearity | Verify the linear range of
the absolute values for
each lymphocyte subset
populations on the
AQUIOS CL Flow
Cytometry System. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Linearity
(Section 11) | Evaluation of the Linearity of
Quantitative Measurement
Procedures: A Statistical
Approach; Approved
Guideline; April 2003. CLSI
EP06-A; FDA Standards
Recognition #7-193 | Analysis of the data collected
demonstrates that the AQUIOS CL
meets the linearity performance
requirements. |
| Assay Carryover | To verify carryover of
whole blood and reagents
on the AQUIOS CL meets
performance
specifications. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Carryover
(Section 12) | Validation, Verification, and
Quality Assurance of
Automated Hematology
Analyzers, Approved Standard
- 2nd Edition; June 2010;
CLSI H26-A2; FDA Standards
Recognition #7-210 | Analysis of the data collected
demonstrates that the AQUIOS CL
meets carryover performance
requirements. |
| Detection
Capability | To verify that the
AQUIOS CL meets the
performance requirements
for Limit of Blank (LoB),
Lower Limit of Detection
(LLoD), Lower Limit of
Quantitation (LLoQ). | None | Evaluation of Detection
Capability for Clinical
Laboratory Measurement
Procedures; Approved
Guideline - Second Edition;
CLSI EP17-A2; FDA
Standards Recognition #7-233 | Analysis of the data collected
demonstrates that the AQUIOS CL
meets the performance requirements for
LoB, LLoD, and LLoQ in whole blood. |
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
| Specimen and
Prepared Sample
Stability | Stability of whole blood
samples will be evaluated
to verify specimen and
prepared sample stability
claims. | None | None | Analysis of the data collected
demonstrates that the AQUIOS CL
Flow Cytometry System meets the
requirements for specimen and prepared
sample stability. |
| Method
Comparison | To evaluate bias between
the subject device versus
the predicate. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Accuracy
(Section 8) | Validation, Verification, and
Quality Assurance of
Automated Hematology
Analyzers, Approved Standard
– 2nd Edition; June 2010;
CLSI H26-A2; FDA Standards
Recognition # 7-210
CLSI EP09-A3, Method
Comparison and Bias
Estimation Using Patient
Samples; Approved Guideline-
-Second Edition (Interim
Revision) | Analysis of the data collected
demonstrates that the AQUIOS CL
Flow Cytometry System meets the
performance requirements when
compared to the predicate device. |
| Precision - Long
Term
Imprecision | Demonstrate system
imprecision using control
material as a surrogate for
a stabilized sample | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Precision
(Section 9) | CLSI EP5-A2, Evaluation of
Precision Performance of
Quantitative Measurement
Methods; Approved Guideline
– Second Edition. | Analysis of the data collected
demonstrates that the AQUIOS CL
meets performance requirements for
Long Term Imprecision. |
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
| Precision –
Whole Blood
Repeatability | Evaluate sample
imprecision using a
precision profile approach
to estimate repeatability at
various medical decision
levels and data
percentiles. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Precision
(Section 9) | CLSI H26-A2, Validation,
Verification, and Quality
Assurance of Automated
Hematology Analyzers | Analysis of the data collected
demonstrates that the AQUIOS CL
meets performance requirements for
Whole Blood Repeatability. |
| Comparability
(Equivalency) –
Anticoagulant,
Sample
Presentation
Mode, Open and
Closed Vial
Sampling Modes,
Test Panel
Equivalency | Provide data on
equivalency of
anticoagulants, modes,
and panels for use on
AQUIOS system. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells - Accuracy
(Section 8) | CLSI EP09-A3, Method
Comparison and Bias
Estimation Using Patient
Samples; Approved Guideline-
-Second Edition (Interim
Revision) | For all conditions evaluated, the data
collected demonstrates that the
AQUIOS CL within-method
comparisons are equivalent. |
| Adult Reference
Intervals | Establish adult reference
intervals for lymphocyte
subset analysis on the
AQUIOS system. | Special Controls
Guidance Document:
Premarket Notifications
for Automated
Differential Cell
Counters for Immature
or Abnormal Blood
Cells – Reference
Values (Section 14) | C28-A3c, Defining,
Establishing, and Verifying
Reference Intervals in the
Clinical Laboratory | Adult reference intervals were
established and confirmed to be
consistent with published values for T,
B, and NK lymphocyte subsets. |
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
| Stability | Stability testing will
demonstrate the shelf life
of the reagents. | None | CLSI EP25-A - Evaluation of
Stability of In Vitro Diagnostic
Reagents. Approved Guideline | Analysis of the data collected
demonstrates that the AQUIOS Tetra-1
and Tetra-2+ reagents meet performance
requirements in support of the product's
stability claims. |
| Lot Variability | Variability of multiple
lots of material was
incorporated into the
overall system variability
assessed in the clinical
testing. | None | CLSI EP5-A2, Evaluation of
Precision Performance of
Quantitative Measurement
Methods; Approved Guideline - Second Edition. | Analysis of the data collected
demonstrates that the AQUIOS Tetra-1
and Tetra-2+ have acceptable lot
variability performance. |
Summary of AQUIOS CL Flow Cytometer Performance Testing
27
28
29
30
31
Summary of AQUIOS Tetra-1 and Tetra-2+ Performance Testing:
Summary of AQUIOS Immuno-Trol and Immuno-Trol Low Performance Testing:
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Assay Value
Assignment and
Expected Ranges | Determine the expected
ranges (count, percent,
separation quotient) for
both levels of control as
well as the process to
assign these values to
each lot of material. | None | None | Assay value assignment process and
expected ranges were established and
verified based on analysis of the data
collected. |
| Stability | Stability testing will
demonstrate the shelf life
of the reagents. | None | CLSI EP25-A – Evaluation of
Stability of In Vitro Diagnostic
Reagents. Approved Guideline | Analysis of the data collected
demonstrates that the AQUIOS
Immuno-Trol and Immuno-Trol Low
meet performance requirements in |
32
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
|-----------------|-------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | support of the product's stability claims. |
| Lot Variability | Verify lot variability of
AQUIOS Immuno-Trol
and Immuno-Trol Low. | None | CLSI EP5-A2, Evaluation of
Precision Performance of
Quantitative Measurement
Methods; Approved Guideline
- Second Edition. | Analysis of the data collected
demonstrates that the AQUIOS
Immuno-Trol and Immuno-Trol Low
have acceptable lot variability
performance. |
Summary of AQUIOS Lysing Reagent Kit Performance Testing:
| Study | Testing Approach | FDA Guidance
Documents | Standards/ References | Testing Results |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Stability testing will
demonstrate the shelf life
of the reagents. | None | CLSI EP25-A - Evaluation of
Stability of In Vitro Diagnostic
Reagents. Approved Guideline | Analysis of the data collected
demonstrates that the AQUIOS Lyse
reagents meet performance requirements
in support of the product's stability
claims. |
| Lot Variability | Variability of multiple
lots of material was
incorporated into the
overall system variability
assessed in the clinical
testing. | None | CLSI EP5-A2, Evaluation of
Precision Performance of
Quantitative Measurement
Methods; Approved Guideline
- Second Edition. | Analysis of the data collected
demonstrates that the AQUIOS Tetra-1
and Tetra-2+ have acceptable lot
variability performance. |
33
Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:
The AQUIOS CL Flow Cytometry System, that is the subject of this submission, in concert with the conclusions drawn from the performance testing discussed above demonstrate that when compared to the predicate device is as safe, as effective, and meets the performance acceptance criteria.
In summary, the AQUIOS CL Flow Cytometry System as described in this submission is substantially equivalent in terms of safety and effectiveness to its predicate devices.
- . The AQUIOS CL Flow Cytometer and AQUIOS Tetra-1 and Tetra-2+ reagents are substantially equivalent to the FACSCalibur CaliBRITE 4 kit and FACSComp Software as well as the UniCel DxH 800, where applicable.
- The AQUIOS Immuno-Trol and Immuno-Trol Low are substantially equivalent to Immuno-Trol Cells and Immuno-Trol Low Cells.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.