R&D CBC-3D + CRP HEMATOLOGY CONTROL

K061511 · R&D Systems, Inc. · JPK · Jul 10, 2006 · Hematology

Device Facts

• Record ID: K061511
• Device Name: R&D CBC-3D + CRP HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.

Device Story

R&D CBC-3D + CRP is a hematology control; used to monitor performance of hematology analyzers. Modification involves addition of C-Reactive Protein (CRP) component and updated assay sheet parameters. Device functions as a reference material to verify analyzer accuracy/precision. Used in clinical laboratory settings by laboratory technicians. Output provides expected values for hematology parameters; assists clinicians in validating instrument performance and ensuring reliable patient test results.

Clinical Evidence

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

Technological Characteristics

Tri-level hematology quality control mixture. Designed for impedance-based hematology analyzers. Stability: 105 days closed vial, 14 days open vial at 2-8°C.

Indications for Use

Indicated for use as a tri-level quality control material to monitor performance of automated and semi-automated impedance-based hematology analyzers and manual hematology methods.

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-3D Hematology Control (K843962)

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 K061511 R&D CBC-3D + CRP

Hematology Control

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 device modifications for the addition of the new parameters to the assay sheet and device formulation modification of the addition of C Reactive Protein (CRP) component. The manufacture remains unchanged. The only labeling changes are for the inclusion of the new parameters.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and 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
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.

Leonthena R. Carrington
(Reviewer's Signature)
7/6/2006
(Date)

revised:8/1/03

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