R & D SYSTEMS XERET HEMATOLOGY CONTROL

K100050 · R&D Systems, Inc. · JPK · Jan 29, 2010 · Hematology

Device Facts

• Record ID: K100050
• Device Name: R & D SYSTEMS XERET HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jan 29, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers.

Device Story

XERet Hematology Control is an in vitro diagnostic reagent consisting of stabilized human and porcine cells in a plasma-like fluid with preservatives. It functions as a quality control material for monitoring reticulocyte counting methods on Sysmex® hematology analyzers. The control is sampled by laboratory personnel in the same manner as a patient specimen. By providing known values for RBC, RET%, RET#, and IRF parameters, it allows clinicians to verify the accuracy and precision of hematology analyzer performance, ensuring reliable patient test results.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures; results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Tri-level, assayed hematology control. Composition: stabilized human and porcine cells in plasma-like fluid with preservatives. Intended for use with Sysmex® hematology analyzers. Parameters: RBC, RET%, RET#, IRF.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of RBC, RET%, RET#, and IRF parameters on Sysmex XE-series automated hematology analyzers in clinical laboratory settings.

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.

Predicate Devices

• R&D Systems CBC-XE Hematology Control (K042094)

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 K100050

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 CBC-XE Hematology Control, K042094, previously cleared device.
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 to the CBC-XE Hematology Control to produce a control for the assay of RBC, RET%, RET#, and IRF parameters only.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is that the control is for RBC, RET%, RET#, and IRF parameters only.
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 (see page 19)
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. (page 19)
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 Attachment 5)
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 Attachment 5)
iii) 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.