(183 days)
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No
The document describes a hematology control material used for quality control of a hematology analyzer, not the analyzer itself or any software within it. There is no mention of AI or ML in the description of the control material or its intended use.
No.
This device is an in vitro diagnostic reagent used as a quality control for hematology analyzers, not for treating patients.
No
The device, BC-5D Hematology Control, is used to monitor the performance of hematology analyzers, not to diagnose a patient's condition. It serves as a quality control reagent for diagnostic equipment.
No
The device description clearly states it is an "in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it is "an assayed whole blood control designed for Mindray BC-5390... Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, etc." This indicates its use in a laboratory setting to assess the performance of a diagnostic instrument.
- Device Description: It is described as "an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives." The term "in vitro diagnostic reagent" directly identifies it as an IVD. It also states its purpose is "monitoring the performance of hematology blood cell counters," which are diagnostic devices.
- Intended User / Care Setting: While the analyzer is used by trained medical professionals, the control itself is used within the laboratory setting to ensure the accuracy of the diagnostic results produced by the analyzer.
- Predicate Device: The predicate device listed (R&D Systems CBC-XE Hematology Control) is also a hematology control, which are typically classified as IVDs.
Therefore, based on the provided information, the BC-5D Hematology Control is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations.
BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
It is only to be used by trained medical professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Following the manufacture and analysis of three verification lots from which the "assay range" for each parameter was determined. 3 validation lots of BC-5D Hematology Controls were manufactured and tested. Results verified the product to have substantial equivalence in performance, precision and stability to the predicate device. The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product. Expiration dating is established at 75 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C, and handled according to instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
R&D Systems CBC-XE Hematology Control, (K042094)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, stacked on top of each other, forming a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
R&D Systems, Inc. Rachel Somsen Associate Director, Quality Assurance and Regulatory Affairs 614 McKinley Place N.E. Minneapolis, MN 55413
Re: K160606
Trade/Device Name: BC-5D Hematology Controls Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: August 3. 2016 Received: August 5, 2016
Dear Ms. Somsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kelly Oliner-S
For
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160606
Device Name BC-5D Hematology Controls
Indications for Use (Describe)
BC-5D is an assayed whole blood control designed for Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, and MPV.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter Information
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Rachel Somsen Phone: 612-851-4846 Fax: 612-379-6580 Date Prepared: August 26, 2016
Device Information
| Proprietary Name: | BC-5D Hematology Controls |
|---|---|
| Common Name: | Hematology Control |
| Classification | 21 CFR 864.8625 |
| Classification Name: | Hematology Quality Control Mixture |
| Product Code: | JPK |
| Device Class: | II |
| Panel: | Hematology (81) |
Predicate Device
R&D Systems CBC-XE Hematology Control, (K042094)
Instrument
Mindray BC-5390 Hematology Analyzer (K160429)
Description of Device
The Mindray BC-5390 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. It is only to be used by trained medical professionals to identify the normal patient, with all normal systemgenerated parameters, and to flag or identify patient results that require additional studies.
The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations.
BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.
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Intended Use
BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.
Technological Comparison to Predicate
The subject device has the same technological characteristics as the legally marketed predicate device. The BC-5D Hematology Control is intended to be used to monitor values obtained on Mindray BC-5000 series hematology analyzers. The predicate device is used to monitor values obtained on Sysmex Hematology Instruments.
The predicate device is assayed for : WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, PDW, MPV, P-LCR, IRF, NEUT#, LYMPH#, MONO#, EO#, BASO#, NRBC#, RET#, Neut%, Lymph%, Mono%, Eo%, Baso%, Nrbc%, and Ret%.
Summary of Performance Data
Following the manufacture and analysis of three verification lots from which the "assay range" for each parameter was determined. 3 validation lots of BC-5D Hematology Controls were manufactured and tested. Results verified the product to have substantial equivalence in performance, precision and stability to the predicate device. The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product. Expiration dating is established at 75 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C, and handled according to instructions for use.
Substantial Equivalence Conclusion
The data demonstrates that the BC-5D Hematology Control is substantially equivalent to the legally marketed predicate device.