BC-5D Hematology Control

K160606 · R&D Systems, Inc. · JPK · Sep 1, 2016 · Hematology

Device Facts

• Record ID: K160606
• Device Name: BC-5D Hematology Control
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

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.

Device Story

BC-5D is a stabilized in vitro diagnostic quality control product; consists of three levels (Low, Normal, High). Composed of human erythrocytes, mammalian leukocytes, and platelets in plasma-like fluid with preservatives. Used in clinical laboratory settings to monitor performance of Mindray BC-5390 Auto Hematology Analyzer. Healthcare providers analyze control samples alongside patient samples; results compared against assigned assay ranges to verify instrument accuracy and precision. Benefits patient by ensuring reliability of complete blood count and 5-part leukocyte differential results.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated via multisite study (80 measurements per lot/level over 20 days). Stability verified via real-time studies for 14-day open-vial and 75-day closed-vial claims per CLSI EP05-A3 and EP25-A.

Technological Characteristics

Stabilized in vitro diagnostic product; human erythrocytes, mammalian leukocytes, and platelets in plasma-like fluid. Three levels (Low, Normal, High). Designed for Mindray BC-5390 Auto Hematology Analyzer. Standards: CLSI EP05-A3 (precision), CLSI EP25-A (stability).

Indications for Use

Indicated for use as an assayed whole blood control to monitor the accuracy and precision of the Mindray BC-5390 Auto Hematology Analyzer. For prescription use only.

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

• R&D Systems CBC-XE Hematology Control (K042094)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Fax: [phone] 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.