CSF AUTOMATED CONTROL, MODELS CSF001, CSF003

K072846 · R&D Systems, Inc. · JPK · Nov 26, 2007 · Hematology

Device Facts

• Record ID: K072846
• Device Name: CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CSF Automated Control is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

Device Story

CSF Automated Control is an in vitro diagnostic reagent used to monitor the performance of hematology instruments analyzing cerebrospinal fluid (CSF). The device consists of human erythrocytes and bovine leukocytes suspended in a preservative-containing, CSF-like fluid. It serves as an assayed whole blood control, providing target values for WBC and RBC counts, as well as differential cell percentages (neutrophils, lymphocytes, monocytes, eosinophils, mononuclear, and polymorphonuclear cells). Healthcare providers use the control to verify the precision and accuracy of hematology analyzers in clinical laboratory settings. By comparing instrument results against the control's target values, clinicians ensure the reliability of patient CSF analysis, which is critical for diagnosing neurological conditions.

Clinical Evidence

No clinical data. Bench testing established stability for 105 days (closed vial) and 14 days (open vial) at 2-8° C, validated across three lots of two levels.

Technological Characteristics

In vitro diagnostic reagent; human erythrocytes and bovine leukocytes in CSF-like fluid with preservatives. Storage: 2° C to 8° C. Open vial stability: 14 days. Closed vial stability: 105 days.

Indications for Use

Indicated for use as an assayed control to monitor values obtained using hematology instruments that measure cerebrospinal fluid (CSF) samples. For in vitro diagnostic use.

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

• Bayer Diagnostics ADVIA TESTpoint™ CSF Controls (K022968)

Submission Summary (Full Text)

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K072846

# 510(k) Summary

#### Submitter Information

R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

Contact: Nancy Ring Phone: [phone] Fax: [phone]

NOV 2 6 2007

Date Prepared: 9/28/07

### Device Information

Proprietary Name: CSF AUTOMATED CONTROL Common Name: Hematology Controls Classification 21 CFR 864.8625 Classification Name: Hematology Quality Control Mixture Product Code: JPK Device Class: = Panel: Hematology (81)

#### Predicate Device

Bayer Diagnostics (now Siemens) ADVIA TESTpoint CSF Controls (K022968)

#### Description of Device

CSF AUTOMATED CONTROL is an in vitro diagnostic reagent composed of human erythrocytes and bovine leukocytes suspended in a cerebrospinal like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained using hematology instruments that measure CSF (cerebral spinal fluid) samples. It is sampled in the same manner as a patient specimen.

#### Intended Use:

CSF AUTOMATED CONTROL is an assayed whole blood control designed to monitor values obtained using hematology instruments that measure CSF samples. Refer to the assay table for specific instrument models.

#### Technological Comparison to Predicate

The new device has the same technological characteristics and intended use as the legally marketed predicate device. Both products are used to monitor values from analyzers that measure CSF samples. Both are used to perform quality control assays on the same parameters.

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# Summary of Performance Data

Laboratory testing of 3 validation lots has shown the CSF AUTOMATED CONTROL to have substantial equivalence in performance, precision and stability to the predicate device. The CSF Automated Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product.

## Substantial Equivalence Conclusion

The data demonstrates that the CSF AUTOMATED CONTROL is substantially equivalent to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 2007

R & D Systems, Inc. C/O Nancy C. Ring 614 McKinley Place, N.E. Minneapolis, Minnesota 55413

Re: k072846

Trade/Device Name: CSF Automated Control, Models CSF001, CSF003 Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: September 28, 2007 Received: October 11, 2007

Dear Ms. Ring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert K. Boetzel

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: _ CSF AUTOMATED CONTROL

Indications for Use:

CSF AUTOMATED CONTROLS is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

For in vitro Diagnostic Use Only

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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RH/Office of In Vitro Diagnostic Devices (OIVD)

Stephene Rantuter
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k).

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