R&D LH-NRBC HEMATOLOGY CONTROL

K061320 · R&D Systems, Inc. · JPK · Jun 2, 2006 · Hematology

Device Facts

• Record ID: K061320
• Device Name: R&D LH-NRBC HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.

Device Story

Tri-level hematology control; used to monitor performance of Coulter® hematology instruments and auxiliary methods. Product serves as reference material to verify instrument accuracy and precision. Laboratory personnel use control to ensure hematology analyzers remain within established assay ranges. Stability established at 75 days (closed vial) and 14 days (open vial) at 2-8°C.

Clinical Evidence

Bench testing only. Validation performed on 3 lots to assess performance, precision, and stability. Results confirmed device remains within assay range over product life. Precision demonstrated via small standard deviation and % CVs.

Technological Characteristics

Tri-level hematology control mixture. Liquid form factor. Designed for use with Coulter® hematology instruments. Stability: 75 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 the performance of Coulter® hematology instruments and auxiliary 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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K061320

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 Nucleated Red Blood Cell (nRBC) and nRBC% parameters.

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 nRBC components.

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