R&D CBC-XE HEMATOLOGY CONTROL

K042094 · R&D Systems, Inc. · JPK · Sep 1, 2004 · Hematology

Device Facts

• Record ID: K042094
• Device Name: R&D CBC-XE HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to the assay sheet for specific instrument models.

Device Story

R&D CBC-XE Hematology Control is a tri-level control mixture used to monitor the performance of Sysmex hematology instruments. It serves as a quality control tool for laboratory professionals to verify instrument accuracy and precision. The control is processed by the hematology instrument similarly to a patient sample; the instrument measures the control and provides output values for various hematology parameters. Clinicians and laboratory staff compare these output values against established assay ranges provided in the product documentation. If the results fall within the expected range, the instrument is considered to be performing correctly, ensuring reliable patient test results. The control is stored at 2-8°C and has a shelf life of 75 days (closed) or 14 days/14 samplings (open).

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; results met predetermined acceptance criteria.

Technological Characteristics

Tri-level hematology control mixture. Designed for use with Sysmex hematology instruments. Stability: 75 days closed vial, 14 days/14 samplings open vial at 2-8°C. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as a tri-level quality control material to monitor the accuracy and precision of Sysmex hematology instruments in a clinical laboratory setting.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K042094

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. This change is for the addition of new parameters.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The control contains the addition of new parameters; NRBC#, NRBC%, RET%, RET#, and IRF. In addition, the control formulation includes the addition of porcine reticulocytes.

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.

5. 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