R&D 5D RETIC HEMATOLOGY CONTROL

K130962 · R&D Systems, Inc. · JPK · Jul 24, 2013 · Hematology

Device Facts

• Record ID: K130962
• Device Name: R&D 5D RETIC HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jul 24, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

The CBC-5D Plus Retics is a tri-level hematology control intended for use in clinical laboratories to monitor the precision of hematology analyzers for the parameters listed in the expected values table.

Device Story

R&D 5D Retic Hematology Control is an in vitro diagnostic reagent; composed of stabilized human cells in plasma-like fluid with preservatives. Used as a quality control material to monitor reticulocyte counting methods (RET%, RET#, IRF, MRV) on Coulter® hematology analyzers. Sampled identically to patient specimens. Used in clinical laboratory settings by laboratory personnel. Provides verification of analyzer performance; ensures accuracy of patient test results.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) and ISO 14971 risk management. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Tri-level, assayed hematology control. Composition: stabilized human cells in plasma-like fluid with preservatives. Form factor: liquid reagent. Intended for use on Coulter® hematology analyzers. No electronic or software components.

Indications for Use

Indicated for use in clinical laboratories as a tri-level hematology control to monitor the precision of hematology analyzers for reticulocyte parameters.

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-5D Plus Retics Hematology Control (K072096)

Submission Summary (Full Text)

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K130962

R & D Systems, Inc. R&D 5D Retic Hematology Control June 26, 2013

## 510(k) Summarv

JUL 2 4 2013

#### Submitter Information

R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Ambreen Athar Phone: [phone] (ext. 4136) Fax: [phone] Date Prepared: June 26, 2013

#### Device Information

Proprietary Name: Common Name: Classification Classification Name: Product Code: Device Class: Panel:

R&D 5D Retic Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture льк 11 Hematology (81)

#### Unmodified Predicate Device

R&D Systems CBC-5D Plus Retics Hematology Control, (K072096) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.

#### Description of Device

The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.

#### Intended Use:

R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.

#### Technological Comparison to Predicate

The modified device has the same technological characteristics as the legally marketed predicate device. Both are used to perform quality control assays and both products are used to monitor values obtained from Coulter® hematology analyzers. The predicate device is assaved for WBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, MPV, NEUT #, LYMPH #, MONO #, EO #, BASO #, NEUT%, MONO%, LYMPH%, E0%, BASO%, NRBC#, NRBC%, RBC, RET%, RET%, and IRF whereas the R&D 5D Retic Hematology Control is assayed for only RET%, RET#, IRF, and MRV parameters.

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### Summary of Performance Data

Laboratory testing of 3 validation lots has shown the R&D 5D Retic Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 105 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 demonstrate that the R&D 5D Retic Hematology Control is substantially equivalent to the legally marketed predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2013

R&D SYSTEMS, INC. c/o MS. AMBREEN ATHAR QA/RA SPECIALIST 614 MCKINLEY PLACE, N.E. MINNEAPOLIS MN 55413

Re: K130962

Trade/Device Name: R&D 5D Retic Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: June 26, 2013 Received: July 12, 2013

Dear Ms. Athar:

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 (sec above) into cither 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 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); 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

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Page 2-Ms. Ambreen Athar

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 regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/default.htm for the CDRI-1'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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Maria M. Chan -S

Maria M. Chan. Ph.D. 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): K130962

Device Name: R&D 5D Retic Hematology Control

Indications for Use:

R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.

For in vitro Diagnostic Use Only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Leonthena R. Carrington -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): K130962