IQ BODY FLUIDS CONTROL

K051706 · Streck · JPK · Aug 17, 2005 · Hematology

Device Facts

• Record ID: K051706
• Device Name: IQ BODY FLUIDS CONTROL
• Applicant: Streck
• Product Code: JPK · Hematology
• Decision Date: Aug 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.

Device Story

iQ® Body Fluids Control is a stabilized suspension of human red blood cells and simulated white blood cells in a solution with biological salts and antimicrobial preservatives. Packaged in 8 ml glass vials with polypropylene screw caps; provided in two levels (low and high cell counts). Used in clinical laboratory settings by trained technicians to verify performance of the iQ® Series analyzers equipped with the iQ® Body Fluids Module. The control is processed like a patient sample; the analyzer provides RBC and nucleated cell counts. Technicians compare these results against expected ranges provided on the assay sheet to ensure system accuracy. Benefits include standardized verification of instrument performance for body fluid analysis, ensuring reliable clinical decision-making for patient samples.

Clinical Evidence

Bench testing only. Studies conducted included closed vial stability, open vial stability, alternate site testing, and run-to-run reproducibility. Results demonstrated consistent reproducibility and stability within the claimed parameters.

Technological Characteristics

Stabilized suspension of human red blood cells and simulated white blood cells in biological salts/preservatives. Packaged in 8 ml glass vials with polypropylene screw caps and polyethylene liners. Storage at 2–10°C. Designed for use with iQ® Series analyzers (automated microscopy/imaging).

Indications for Use

Indicated for use as a quality control material for evaluating red blood cell and nucleated cell counts in cerebrospinal and serous fluids when using the iQ® Series analyzers with the iQ® Body Fluids Module.

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

• Cell-Chex (K000076)

Submission Summary (Full Text)

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K051706

# AUG 1 7 2005

## 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: | June 14, 2005 |
| Name of Device: | |
| Trade Name: | iQ® Body Fluids Control |
| Common Name: | Hematology Control for Body Fluids |
| Classification Name: | White and Red Blood Cell Control (864.8625) |
| Predicate Device: | Cell-Chex (K000076) Manufactured by Streck |

### Description:

iQ Body Fluids Control 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 glass vials containing 8ml. The closures are polypropylene screw caps with polyethylene liners. Four vials are included in a set. Two vials are level 1 with a low cell count and the other two vials are level 2 with a higher concentration of cells. The vials are further packaged in a six (6) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 – 10°C.

#### Intended Use:

iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.

#### Comparison to Predicate Device:

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

Unlike Cell-Chex, iQ Body Fluids Control is used for the Iris Diagnostics' iQ Body Fluids Module. Cell-Chex is used with manual diagnostic methods, and Cell-Chex has a 6 (six) month closed vial stability where iQ Body Fluids Control has a 40 day closed vial stability.

#### Discussion of Tests and Test Results:

Four types of studies were conducted to establish performance of iQ Body Fluids Control, closed vial stability, open vial stability, alternate site testing, and run to run reproducibility. All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim.

#### Conclusions Drawn From Tests:

iQ Body Fluids Control is a safe and effective product useful for controlling the Iris Diagnositc Body Fluid Module. It will perform as claimed when used in accordance with the package insert.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 7 2005

Mr. Mark Lewallen Quality Assurance Coordinator Streck 7002 South 109th Street La Vista, Nebraska 68128

k051706 Re:

Trade/Device Name: iQ® Body Fluids Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: August 10, 2005 Received: August 11, 2005

Dear Mr. Lewallen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave a nowe 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 for assession 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.

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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 or questions on the promie Evaluation and Safety at [phone]. Also, please note the vitro Diagnostic D' Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other generers, 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,

lobatz Beckerh

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

Enclosure

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510(k) Number (if known):

Device Name:

Indications For Use:

Kosi706

iQ® Body Fluids Control

iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.

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)

Josephine Buatta

Division

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K051706