CELL-CHEX AUTO

K053362 · Streck · JPK · Jan 13, 2006 · Hematology

Device Facts

• Record ID: K053362
• Device Name: CELL-CHEX AUTO
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

The Streck Cell-Chex Auto control is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

Device Story

Cell-Chex Auto is an assayed, tri-level quality control material; consists of stabilized human red blood cells and simulated white blood cells in a solution with biological salts and anti-microbial preservatives. Packaged in 4 ml plastic vials; available in three concentration levels (Level 1: very low; Level 2: low; Level 3: high). Used in clinical laboratories to evaluate accuracy and precision of hematology instruments analyzing patient body fluid samples. Healthcare providers use the control to verify instrument performance; results falling within established assay ranges confirm system reliability for patient sample testing.

Clinical Evidence

Bench testing only. Studies included closed vial stability, open vial stability, run-to-run reproducibility, and site-to-site recovery of values. Results demonstrated consistent reproducibility and stability for the claimed shelf life, confirming substantial equivalence to the predicate.

Technological Characteristics

Stabilized suspension of human red blood cells and simulated white blood cells in biological salts and anti-microbial preservatives. Packaged in 4ml plastic vials with polypropylene screw caps and polyethylene liners. Three concentration levels. Storage: 2-10°C. Stability: 75 days closed vial, 30 days open vial.

Indications for Use

Indicated for use as an assayed quality control material for hematology instruments measuring blood cell counts in patient body fluid samples.

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

• iQ® Body Fluids Control (K051706)

Submission Summary (Full Text)

{0}------------------------------------------------

K053362

# 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>Omaha, NE 68128 |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Official Correspondent: | Carol Thompson, Quality Assurance Manager<br>(402)-537-5213 |
| Date Prepared: | December 1, 2005 |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | Cell-Chex Auto<br>Hematology Control for Body Fluids<br>White and Red Blood Cell Control (864.8625) |
| Predicate Device: | iQ® Body Fluids Control (K051706) Manufactured by Streck |

### Description:

Cell-Chex Auto is a stabilized suspension of human red blood cells and simulated white blood cells in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels, Level 1 with a very low count, Level with a low count, and a Level 3 with a higher count. 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-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

#### Comparison to Predicate Device:

Like iQ Body Fluids Control, Cell-Chex Auto is an assayed control mixture of red and white blood cells set at specific concentrations. iQ Body Fluids Control and Cell-Chex Auto have a 30 day open vial stability. Both iQ Body Fluids Control and Cell-Chex Auto are automated body fluid controls.

Unlike iQ Body Fluids Control, Cell-Chex Auto has 75 days closed vial stability where iQ Body Fluids Control has 159 days closed vial stability

#### Discussion of Tests and Test Results:

Four types of studies were conducted to establish performance of Cell-Chex Auto. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values. All testing showed that Cell-Chex Auto is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

#### Conclusions Drawn From Tests:

Cell-Chex Auto is an effective quality control material for controlling hematology instruments that measure blood cell counts in body fluid samples when used as indicated on the labeling. It meets the claim of a 75 day closed vial, and a 30 day open vial stablity and consistent run-to-run performance, Reproducibility studies and Closed Vial stability results consistency in the manufacture of Cell-Chex Auto. Customers can be assured of a reliable quality control material that meets their expectations.

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures, each represented by a curved line, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kerrie Oetter Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th Street La Vista, NE 68128

JAN 1 3 2006

Re: k053362 Trade/Device Name: Cell-Chex Auto Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 1, 2005 Received: December 2, 2005

Dear Ms. Oetter:

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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.

{2}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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,

Robert Beckerh

Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

K053362

Device Name:

Cell-Chex Auto

Indications For Use:

Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

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)

Josephine Bautista

Office of In Wire Diagnostic Device Evaluation and Satury

Page 1 of 1

510(2) K053362