CELL-DYN 22 PLUS CALIBRATOR

K111204 · Streck · KRX · Dec 22, 2011 · Hematology

Device Facts

• Record ID: K111204
• Device Name: CELL-DYN 22 PLUS CALIBRATOR
• Applicant: Streck
• Product Code: KRX · Hematology
• Decision Date: Dec 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8150
• Device Class: Class 2

Intended Use

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (10⁹/L), RBC (10¹²/L), HGB (g/dL), MCV (fL), PLT (10⁹/L).

Device Story

CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product used to calibrate the CELL-DYN Emerald 22 hematology system. The product consists of stabilized human or mammalian red blood cells, human, mammalian, or simulated white blood cells, and a platelet component in a preservative medium. It is packaged in 2.5ml polypropylene vials. The calibrator is used by laboratory personnel in a clinical setting to ensure the accuracy of the analyzer's measurements for WBC, RBC, HGB, MCV, and PLT parameters. By providing known values for these parameters, the device allows the analyzer to adjust its internal settings, ensuring accurate patient sample analysis and supporting clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated across 7 CELL-DYN Emerald 22 instruments at 3 sites using 3 lots. All %CV values for WBC, RBC, HGB, MCV, and PLT were <10%, meeting acceptance criteria. Stability verified for 5 days (open vial) and 45 days (closed vial).

Technological Characteristics

Stabilized human/mammalian red blood cells, white blood cells, and platelets in preservative medium. Packaged in 2.5 mL polypropylene vials with screw caps. Storage at 2-10°C. Traceable to reference methods. Evaluated per CLSI EP5-A2 and CLSI H26-A2 standards.

Indications for Use

Indicated for prescription use only for the calibration of the CELL-DYN Emerald 22 hematology system.

Regulatory Classification

Identification

A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

Special Controls

*Classification.* Class II (special controls). 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

• Cal-Chex (k840261)

Submission Summary (Full Text)

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KIII204

### 510(k) Summary of Safety and Effectiveness

DEC 2 2 2011

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| 510(k) Submitter: | Streck |
|-------------------------|-------------------------------------------|
| | 7002 South 109th Street |
| | Omaha, NE 68128 |
| Official Correspondent: | Bert Moses, Director of Quality |
| | [phone] |
| Date Prepared: | April 12, 2011 |
| Name of Device: | |
| Trade Name: | CELL-DYN 22 Plus Calibrator |
| Common Name: | Assayed Hematology Calibrator |
| Classification Name: | Calibrator for Cell Indices (864.8150) |
| Predicate Device: | Cal-Chex (K840261) Manufactured by Streck |

#### Description:

CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian 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. The vials will be packaged in a four (4) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

#### Intended Use:

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.

Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)

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## Comparison to Predicate Device:

| | Cal-Chex (Predicate<br>Product) | CELL-DYN 22 Plus Calibrator |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | Cal-Chex is used to calibrate<br>multi-parameter hematology<br>analyzer | CELL-DYN 22 Plus Calibrator is<br>manufactured for calibration of the CELL-<br>DYN Emerald 22 system.<br>Assayed parameters include: WBC<br>(109/L), RBC (1012/L), HGB (g/dL), MCV<br>(fL), PLT (109/L) |
| Open Vial<br>Stability | 5 days | Same |
| Closed Vial<br>Stability | 45 days | Same |
| Reagents | The whole blood reagent may<br>contain any or all of the<br>following: stabilized human<br>or mammalian red blood cells,<br>human, mammalian or<br>simulated white blood cells<br>and a platelet component in a<br>preservative medium. | Same |
| Storage<br>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 Calibrator. The five tests conducted were Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Venfication and Calibration Equivalency. 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 Calibrator to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Calibrator is a safe and effective product, which fulfills its intended use when used as instructed in the product information sheet.

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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 2 2011

Re: k111204

Trade/Device Name: CELL-DYN 22 Plus Calibrator Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX 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 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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### Indication for Use Form

510(k) Number (if known):

Device Name: CELL-DYN 22 Plus Calibrator

Indications For Use:

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (108/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)

Prescription Use × (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)

Mana M. Chen

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

510(k) K111204

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