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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the BC-5D Hematology Controls, based on the provided text, while noting limitations due to the document's nature as an FDA 510(k) summary, which often doesn't contain detailed study protocols:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states, "The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product." However, it does not explicitly list the quantitative acceptance criteria for each parameter (WBC, Neu#, Lym#, etc.) nor does it provide a table of the reported device performance values against those criteria. It only indicates that the device met the criteria.

Without the specific numerical ranges for acceptance criteria and the actual performance data, a table like the one requested cannot be constructed from the given text. The relevant section notes that an "assay range" was determined for each parameter, and subsequent validation lots "met the acceptance criteria." This implies that the acceptance criteria revolved around the ability of the control to consistently fall within these established assay ranges.

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

Sample Size (Test Set): The study involved testing "3 validation lots" of BC-5D Hematology Controls. The document does not specify the number of individual control samples tested within each lot or the number of measurements taken for each parameter.
Data Provenance: Not explicitly stated, but as a commercial product seeking FDA clearance in the U.S., it's implied that the testing was conducted in a laboratory setting. The data is prospective in the sense that these validation lots were manufactured and tested specifically for the 510(k) submission. No information is given about the country of origin of the data beyond the applicant being R&D Systems, Inc. in Minneapolis, MN, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and therefore not provided in the document because:

The device is a hematology quality control (QC) mixture, not a diagnostic device that relies on expert human interpretation of results (like an imaging device or a histological slide).
The "ground truth" for a QC material is its assayed value, typically established by the manufacturer through rigorous testing using a reference method or consensus methods, not by "experts" in the sense of clinicians or radiologists interpreting results.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for a quality control material where performance is assessed against pre-defined numerical ranges.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret data, and the effect of AI assistance on their performance is evaluated.
The BC-5D Hematology Control is a quality control material for an automated hematology analyzer. It does not involve human interpretation or AI assistance in the diagnostic process itself. Its purpose is to monitor the performance of the analyzer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable in the context of this device.

The BC-5D is a control material, not an algorithm. Its "performance" is its ability to produce consistent and accurate results within its specified assay range when run on the Mindray BC-5390 Hematology Analyzer.
The analyzer itself (Mindray BC-5390) performs in a "standalone" fashion (algorithm-only processing of samples). The control is used to verify that this standalone analyzer is functioning correctly.
The study did evaluate the performance of the control material (i.e., its own characteristics like stability and assayed values) without human intervention in the result generation, but this isn't the typical "standalone algorithm performance" evaluation for a diagnostic AI device.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for a hematology quality control material is its assayed value for each parameter. These values are established by the manufacturer through a combination of:

Reference methods: Using highly accurate and precise analytical methods.
Consensus values: Often by analyzing the control material on multiple instruments or by comparing with primary reference standards.
The document implies that an "assay range" for each parameter was determined during the "manufacture and analysis of three verification lots." This "assay range" essentially defines the expected "ground truth" for the control material when it is functioning correctly.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided.

"Training set" refers to data used to train a machine learning algorithm.
The BC-5D Hematology Control is a physical control material, not a machine learning algorithm. Therefore, there is no "training set" in this context.

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

This information is not applicable and therefore not provided for the same reasons as point 8.

Summary

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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

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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.

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Intended Use

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.

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.