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.
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

Device Description

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.

AI/ML Overview

The provided text describes a medical device, the "CSF AUTOMATED CONTROL," which is an in vitro diagnostic reagent used as a hematology control. The document focuses on demonstrating its substantial equivalence to a predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Remaining within the assay range over the stated life of the product.	The CSF Automated Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product.
Substantial equivalence in performance, precision, and stability to the predicate device.	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.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Laboratory testing of 3 validation lots has shown the CSF AUTOMATED CONTROL to have substantial equivalence..." However, it does not specify the sample size within these lots (i.e., how many individual control samples were tested, or how many measurements were taken from each lot).

The data provenance is presented as "laboratory testing," implying it was conducted under controlled conditions, likely by the manufacturer R&D Systems, Inc. There is no information provided regarding the country of origin of the data, nor whether it was retrospective or prospective. Given the nature of a control reagent, it would typically involve prospective testing in a lab setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The CSF AUTOMATED CONTROL is a quality control reagent designed to monitor the performance of hematology instruments. Its "ground truth" is its own established assay range and its consistency, not a diagnostic interpretation that would require expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods are relevant for studies where human interpretation or diagnosis is being evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC study was not conducted and is not applicable here. This device is a quality control reagent, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable in the context of this device. The CSF AUTOMATED CONTROL is a physical reagent. Its "performance" is its ability to consistently produce results within a defined range when run on an instrument, not an algorithm's output. The study described focuses on the intrinsic properties of the reagent (performance, precision, stability) relative to a predicate.

7. Type of Ground Truth Used

The "ground truth" for this device is its established assay range and its inherent stability, precision, and performance characteristics. This is determined through internal laboratory testing and characterization of the control material itself, rather than expert consensus, pathology, or outcomes data, which are relevant for diagnostic devices.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this physical control reagent. Training sets are used for machine learning algorithms. The study involved "3 validation lots," which served as the test material, not a training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set in the context of this device, this question is not applicable. The "ground truth" for the behavior of the control (its assay range) would have been established through extensive characterization by the manufacturer during its development and manufacturing process, independent of this specific substantial equivalence study.

Summary

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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: 612-656-4533 Fax: 612-379-6580

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

Intended Use:

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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Page 2 – R & D Systems, Inc.

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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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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Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
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).(b)
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.