CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04

K072096 · R&D Systems, Inc. · JPK · Aug 20, 2007 · Hematology

Device Facts

• Record ID: K072096
• Device Name: CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Aug 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

The CBC-5D Plus Retics is a control designed to monitor values on Coulter hematology analyzers. Refer to assay sheet for specific instrument models. It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The CBC-5D Plus Retics Hematology Control is designed to document and monitor values obtained from Coulter® hematology instruments. For in vitro Diagnostic Use Only

Device Story

Modification to existing hematology analyzer; addition of Reticulocyte (RET%, RET#) parameter measurement. Device functions as automated hematology analyzer; inputs blood samples; performs analysis to quantify blood cell components; outputs hematology parameters including new reticulocyte counts. Used in clinical laboratory settings by trained technicians. Output used by clinicians for hematological assessment and patient diagnosis.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to assess impact of reticulocyte parameter addition; results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic control; human erythrocytes, simulated leukocytes, mammalian platelets in plasma-like fluid with preservatives. Liquid form factor. Designed for use with Coulter hematology analyzers. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as an in vitro diagnostic control to monitor the performance of Coulter hematology analyzers in a 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 K072096

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 change was for the addition of the Reticulocyte (RET%, RET#) parameter.

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 number of parameters available, addition of the Reticulocyte (RET) component.

4. 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.

Comments
(Reviewer's Signature)
(Date)

Revised: 3/27/98