R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL

K091433 · R&D Systems, Inc. · JPK · Oct 28, 2009 · Hematology

Device Facts

• Record ID: K091433
• Device Name: R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

Device Story

R&D Systems Retic-I Plus Hematology Control is an in vitro diagnostic reagent; composed of human and avian erythrocytes in plasma-like medium with preservatives. Device provides stabilized material to monitor automated reticulocyte counting methods; sampled identically to patient specimens. Available in three levels (Low, Normal, High) in 4 mL tubes. Stored at 2°–8°C. Used by laboratory personnel to verify instrument performance; output is a control value compared against established ranges to ensure accuracy of patient testing.

Clinical Evidence

Bench testing only. Stability studies (open vial 14 days, closed vial 75 days) confirmed performance within established acceptance criteria (mean ± 0.20 for Level 1; mean ± 0.10 for Levels 2 and 3). Precision/reproducibility data provided for three lots across three levels, showing CV% ranging from 0.71% to 7.58%. Value assignment validated using Coulter LH750 and GENS instruments.

Technological Characteristics

Tri-level assayed hematology control; human and avian erythrocytes in plasma-like medium with preservatives. 4 mL tube packaging. Storage 2°–8°C. Analytes: IRF, Retic%, Retic#, RBC, MCVr. No electronic or software components; purely chemical/biological reagent.

Indications for Use

Indicated for use as an in vitro diagnostic hematology control to monitor automated reticulocyte counting methods. No specific patient population or contraindications described.

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 Advia Retic Plus Hematology Control (K010461)

Submission Summary (Full Text)

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KO91433

# 510(k) Summarv

## Submitter Information

R&D Systems. Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Nancy Ring Phone: [phone] Fax: [phone] Date Prepared: 10/05/09

OCT 2 8 2009

## Device Information

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

Retic-I Plus Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture JPK = Hematology (81)

#### Predicate Device

R&D Systems Advia Retic Plus Hematology Control, (K010461) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.

### Description of Device

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

#### Intended Use:

R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

#### Technological Comparison to Predicate

The new 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 automated reticulocyte counting methods. The R&D Retic-1 Plus Hematology Control is assayed for additional parameters.

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## Summary of Performance Data

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

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

R & D Systems, Inc c/o Ms. Nancy Ring Sr. Quality Assurance/Regulatory Affairs Specialist 614 McKinley Place, N.E. Minneapolis, MN 55413

OCT 2 8 2009

Re: k091433

Trade/Device Name: R&D Systems Retic-I Plus Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: September 16, 2009 Received: September 17, 2009

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 - Ms. Ring

will allow you to begin marketing your device as described in your Section 510(k) premarket 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m. Chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices 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: R&D Retic-1 Plus Hematology Control

Indications for Use:

R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

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)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) 091433