CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554

K071681 · Beckman Coulter, Inc. · GKZ · Oct 4, 2007 · Hematology

Device Facts

• Record ID: K071681
• Device Name: CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Oct 4, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Cytomics FC 500 MPL is a system for the qualitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.

Device Story

Modified flow cytometry system enabling sample introduction from multi-well microplates in addition to standard tubes. System utilizes aspiration and dispensing for sample mixing; includes external 10L sheath fluid and 20L waste containers. Operated in laboratory settings by trained personnel. Output provides analytical data for clinical decision-making. Modifications include hardware for plate sampling, software updates for 21 CFR Part 11 compliance, and revised maintenance procedures for fluid management. System lacks bar-code reading capability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flow cytometry system; hardware supports multi-well microplate and tube sampling; aspiration/dispensing mixing mechanism; external 10L sheath fluid and 20L waste containers; software supports 21 CFR Part 11 compliance.

Indications for Use

Indicated for qualitative and quantitative measurement of biological and physical properties of cells and other particles in clinical laboratory settings.

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 K071681

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 hardware, software, and labeling changes to support sample presentation/introduction from multi well plates.

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

a) The hardware and software differences are:
- Prepared sample can also be added to a multi-well microplate.
- Prepared sample is mixed using an aspiration and dispensing method.
- Multi-well plate sampler w/tube sampling capability as well.
- No bar-code reading capability.
- Some slight differences in cleaning cycles based on sampling systems.
- External 10L sheath fluid container & 20L waste container.

b) The labeling differences are:
- Updates related to the ability to sample from plates
- Description of and maintenance procedures for waste and sheath containers.
- Instructions for 21 CFR Part 11 option.
- Modified installation instructions.

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

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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)

Comments

The following information and documentation was requested and provided:

Reproducibility, carryover, and correlation testing summary and results
Verification/Validation test results of software validation

Revised: 3/27/98