CELL-DYN 22 PLUS CONTROL

K111211 · Streck · GLQ · Dec 22, 2011 · Hematology

Device Facts

• Record ID: K111211
• Device Name: CELL-DYN 22 PLUS CONTROL
• Applicant: Streck
• Product Code: GLQ · Hematology
• Decision Date: Dec 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (10^9/L), RBC (10^12/L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10^9/L), MPV (fL), NEU (%), NEU (10^9/L), LYM (%), LYM (10^9/L), MON (10^9/L), EOS (%), EOS (10^9/L), BAS (%), BAS (10^9/L)

Device Story

CELL-DYN 22 Plus Control is an in-vitro diagnostic product used for quality control of the CELL-DYN Emerald 22 hematology system. The control consists of stabilized human red blood cells, human/mammalian/simulated white blood cells, and a platelet component in a preservative medium. It is provided in three levels (low, normal, high) in polypropylene vials. Laboratory personnel use the control to verify system performance by comparing measured values against the provided assay sheet. Consistent performance of the control ensures the accuracy and precision of patient sample analysis on the hematology analyzer. The product requires refrigerated storage (2-10°C).

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated using three lots of control material across seven CELL-DYN Emerald 22 instruments at three sites. Repeatability assessed via 10 consecutive runs per vial. All %CV values for measured parameters were within acceptable thresholds. Stability testing (open-vial 8-day and closed-vial 75-day) confirmed performance consistency over the claimed shelf life.

Technological Characteristics

Stabilized human/mammalian red blood cells, white blood cells, and platelet component in preservative medium. Polypropylene vials with polyethylene-lined caps. 2.5 mL volume. Storage 2-10°C. Designed for use with Abbott CELL-DYN Emerald 22 hematology analyzer. Complies with CLSI EP5-A2 (precision) and CLSI H26-A2 (validation/verification) guidelines.

Indications for Use

Indicated for use as an assayed hematology control to evaluate the accuracy and precision of the CELL-DYN Emerald 22 system in clinical laboratory settings.

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

• Para 12 Plus (k901875)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

DEC 2 2 2011

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Bert Moses, Director of Quality<br>(402)537- 5343 |
| Date Prepared: | April 14, 2011 |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | CELL-DYN 22 Plus Control<br>Assayed Hematology Control<br>Hematology quality control mixture (864.8625) |
| Predicate Device: | Para 12 Plus (K901875) Manufactured by Streck |

### Description:

CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

### Intended Use:

CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%),
EOS (10°/L), BAS (%), BAS (10°/L)

| | Para 12 Plus (Predicate Product) | CELL-DYN 22 Plus Control |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | Para 12 Plus is an assayed<br>hematology control for evaluating<br>the accuracy and precision of<br>hematology instruments that provide<br>a white blood cell differential. | CELL-DYN 22 Plus Control is an<br>assayed hematology control for<br>evaluating the accuracy and precision<br>of the CELL-DYN Emerald 22 system.<br><br>Assayed parameters include:<br>$WBC (10^9/L), RBC (10^{12}/L), HGB$<br>(g/dL), HCT (%), MCV (fL), MCH (pg),<br>MCHC (g/dL), RDW (%), PLT $(10^9/L)$ ,<br>MPV (fL), NEU (%), NEU $(10^9/L)$ , LYM<br>(%), LYM $(10^9/L)$ , MON (%), MON<br>$(10^9/L)$ , EOS (%), EOS $(10^9/L)$ , BAS<br>(%), BAS $(10^9/L)$ |
| Open Vial Stability | 7 days | 8 days |
| Closed Vial Stability | 75 days | Same |

### Comparison to Predicate Device:

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| Reagents | The whole blood reagent may<br>contain any or all of the following:<br>stabilized human or mammalian red<br>blood cells, human, mammalian or<br>simulated white blood cells and a<br>platelet component in a preservative<br>medium. | Same |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Storage Conditions | 2 - 10°C | Same |

### Discussion of Tests and Test Results:

Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Control. The five tests conducted were Closed-Vial Stability, Open-Vial Stability, 10-Run Reproducibility, 10-Run Reproducibility compared with Whole Blood and External Site recovery of values. All testing showed that CELL-DYN 22 Plus Control is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

## Conclusions Drawn From Tests:

Study results show CELL-DYN 22 Plus Control to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Control is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Streck Inc. c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128

DEC & 2 2011

Re: k111211

Trade/Device Name: CELL-DYN 22 Plus Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLQ Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. Kipp:

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. Deborah Kipp

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/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 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,

.maria mchen

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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### Indication for Use Form

510(k) Number (if known):

K///2//

Device Name: CELL-DYN 22 Plus Control

Indications For Use:

CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (108/L), RBC (1012/L), HGB (g/dL), HCT (%), MCV (pg), MCHC (g/dL), RDW (%), PLT (10%L), MPV (fL), NEU (%), NEU (10%L), LYM (%), LYM (109%), MON (108%), EOS (%), EOS (10°/L), BAS (%), BAS (10°/L)

Prescription Use X (Per 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 Diagnostic Devices (OIVD)

m. Chen

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

**510(k)** K111211

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