(53 days)
Not Found
No
The device is a control reagent for hematology instruments, not a software or hardware device that would typically incorporate AI/ML. The description focuses on its composition and function as a control.
No.
This device is an in vitro diagnostic control used to monitor the performance of hematology instruments, not to directly treat or diagnose a disease in a patient.
No.
This device is a control material used to monitor the performance of hematology instruments, not to diagnose a condition in a patient. It is explicitly stated as "an assayed whole blood control designed to monitor values obtained using hematology instruments."
No
The device is described as an in vitro diagnostic reagent composed of biological materials (human erythrocytes, bovine leukocytes) and fluid, clearly indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the "Intended Use / Indications for Use" section: "For in vitro Diagnostic Use Only"
- Explicitly stated in the "Device Description" section: "CSF AUTOMATED CONTROL is an in vitro diagnostic reagent..."
- Its function is to monitor values obtained using hematology instruments that measure CSF samples: This is a diagnostic process performed outside of the body (in vitro) on a sample (CSF).
N/A
Intended Use / Indications for 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.
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
Product codes
JPK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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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