CD4 COUNT

K083926 · Streck · GGL · Feb 11, 2009 · Hematology

Device Facts

• Record ID: K083926
• Device Name: CD4 COUNT
• Applicant: Streck
• Product Code: GGL · Hematology
• Decision Date: Feb 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cells subsets on a flow cytometry instrument.

Device Story

CD4 Count is a stabilized whole blood control used to monitor the precision and accuracy of flow cytometry instruments. It consists of stabilized human red and white blood cells in a preservative medium, provided in 2.5 ml vials in two levels (Normal and Low). The device is used by laboratory personnel in a clinical setting. The user processes the control like a patient sample on a flow cytometer. The instrument measures the control, and the user compares the resulting values against the expected ranges provided on the assay sheet. This process confirms that the instrument is functioning correctly and provides quality control data for clinical testing protocols.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies (CV%) were within acceptable limits. Stability studies (open vial 30 days, closed vial 60 days) confirmed parameter recovery within expected ranges. Value assignment was performed via replicate analysis on BD FACSCount analyzers.

Technological Characteristics

Stabilized human red and white blood cells in preservative medium. Form factor: 2.5 ml plastic vials. Storage: 2–10°C. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as an assayed whole blood quality control for evaluating white blood cell subsets on flow cytometry instruments 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

• CD-Chex® Plus BC (K051633)

Submission Summary (Full Text)

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K083926

## 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>[phone] |
| Date Prepared: | December 30, 2008 |
| Names of Device: | |
| Trade Name: | CD4 Count |
| Common Name: | Immunophenotyping Control |
| Classification Name: | White Cell Control, 21CFR864.8625 |
| Predicate Device: | CD-Chex® Plus BC (K051633) |

# Predicate Device:

Description: CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell"

#### Intended Use: ·

box.

CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument

### Comparison with Predicate Device:

| | CD-Chex Plus BC<br>(Predicate Product) | CD4 Count |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use Statement | CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments. | CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument |
| Open Vial Stability | 30 days | Same |
| Closed Vial Stability | 90 days | 60 days |
| Reagents | Contains stabilized human blood in a preservative medium. | Same |
| Storage Conditions | 2 - 10°C | Same |

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#### Testing Performed:

Four studies of CD4 Count were conducted: 1) Run to Run Reproducibility & Whole Pour Statios of OD F Stability, 3) Closed Vial Stability, and 4) Alternate Site Testing. Study results showed CD4 Count to be consistently reproducible and stable for the entire product dating.

### Conclusions Drawn from the Tests:

Study results show CD4 Count to be consistently reproducible, substantially equivalent i to the predicate product, and stable for the entire product dating. CD4 Count is a safe lo the product, which fulfills its intended use when used as instructed in the product package insert.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Streck Inc. c/o Ms. Kerrie Oetter Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128

FEB 1 1 2009

Re: k083926

Trade/Device Name: CD4 Count Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: GGL Dated: December 30, 2008 Received: December 31, 2008

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 (OS) 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.

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#### Page 2 - Ms. Kerrie Oetter

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 Inchar

Maria M. Chan, Ph.D. Acting Division 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

K083926 510(k) Number (if known):

Device Name: CD4 Count

Indication For Use:

CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Joachim Bautista

Division Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083926