BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402

K071141 · Bd Biosciences · GKZ · Jun 6, 2007 · Hematology

Device Facts

• Record ID: K071141
• Device Name: BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
• Applicant: Bd Biosciences
• Product Code: GKZ · Hematology
• Decision Date: Jun 6, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL.

Device Story

Reagent kit for flow cytometry; utilizes direct immunofluorescence to identify/enumerate T lymphocytes (CD3+) and T helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood. Input: blood sample; processed via flow cytometer (488 nm laser). Output: cell percentages and absolute counts (cells/µL) when used with Trucount Absolute Count Tubes. Used in clinical laboratory settings by trained technicians/physicians. Analysis performed via MultiSET, CELLQuest, CELLQuest Pro, or LYSYS II software. Output assists clinicians in monitoring autoimmune and immunodeficiency diseases (e.g., HIV). Modification extends EDTA sample stability from 48 to 72 hours.

Clinical Evidence

Bench testing only; verification and validation activities performed to support extended stability claim for EDTA whole blood samples.

Technological Characteristics

Three-color direct immunofluorescence reagent (CD3 FITC, CD4 PE, CD45 PerCP). Uses flow cytometry with 488 nm laser excitation. Detection ranges: 510-545 nm, 562-607 nm, and >650 nm. Includes Trucount Absolute Count Tubes for quantification. Compatible with various flow cytometry analysis software packages.

Indications for Use

Indicated for use with 488 nm laser flow cytometers for identifying and enumerating T lymphocytes (CD3+) and T helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole peripheral blood. Used to characterize and monitor autoimmune diseases and immunodeficiency diseases, such as HIV infection.

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.”

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K071141

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.
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.

The modification is for the extension of the whole blood sample stability claim for EDTA.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the whole blood sample stability claim for EDTA which is changed to 72 hours instead of 48 hours.

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
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
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
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.

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

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.

(Reviewer's Signature)
(Date)

Revised: 3/27/98