TETRACHROME REAGENTS AND TETRACXP SYSTEM

K121445 · Beckman Coulter, Inc. · OYE · Jul 26, 2013 · Hematology

Device Facts

• Record ID: K121445
• Device Name: TETRACHROME REAGENTS AND TETRACXP SYSTEM
• Applicant: Beckman Coulter, Inc.
• Product Code: OYE · Hematology
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers. The reagents may also be used with the tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or with tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers. Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use" and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5. The tetraCXP Software for Cytomics FC 500 flow cytometry systems, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using Cytomics FC 500 flow cytometry systems with CXP Software. The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts. The system also provides the CD4/CD8 ratio. The system with CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+ (T), CD19+ (B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. This reagent reflects the distribution of the three major subsets comprising the lymphocyte population upon which other lymphocyte enumeration studies are based.

Device Story

System uses monoclonal antibody reagents labeled with fluorochromes to bind specific cell surface antigens on lymphocytes in whole blood. Samples are processed via flow cytometry; white cells analyzed using manual or automated gating. tetraCXP SYSTEM software automates cytometer standardization, compensation (via QuickCOMP 4 Cells), and analysis of lymphocyte populations. Output includes percentages and absolute counts of T, B, and NK cell subsets and CD4/CD8 ratios. Used in clinical laboratory settings by trained personnel to assist in immunological assessment. Benefits include standardized, automated enumeration of lymphocyte subsets, reducing manual variability.

Clinical Evidence

No clinical data; bench testing only. Verification and validation activities performed per design control requirements to support labeling modifications.

Technological Characteristics

Reagent system for flow cytometry. No changes to hardware, software, or reagent composition. Packaging and manufacturing processes remain identical to predicate. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to identify and enumerate lymphocyte subsets (T, B, and NK cells) and their percentages/absolute counts in whole blood samples using flow cytometry. Used for monitoring lymphocyte populations, including CD4/CD8 ratios.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• tetraCHROME Reagents (K030408)
• tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometer with CXP Software (K030828)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k121445

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:
a. Modification of specimen stability claims
b. Labeling modifications regarding quality control.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance.

Predicate(s):
K030408 tetraCHROME Reagents
K030828 tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometer with CXP Software

Similarities:
Same Intended Use,
Same operating principle,
Same design (no changes to hardware, software or reagents),
Same reagent shelf life, and
Same material packaging and processes.

Differences:
Claims made in the product labeling for reduced specimen stability.
Claims clarified in the product labeling for prepared sample stability.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). (See Section 012, Design Controls Activities page 3.)

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b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (See Section 012, Design Controls Activities page 3.)

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and (see Section 014 Declaration of Conformity and Compliance, page 1)

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (see Section 014 Declaration of Conformity and Compliance, page 1.)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.