RETIC-CHEX FOR CELL-DYN

K042587 · Streck Laboratories, Inc. · JPK · Oct 19, 2004 · Hematology

Device Facts

• Record ID: K042587
• Device Name: RETIC-CHEX FOR CELL-DYN
• Applicant: Streck Laboratories, Inc.
• Product Code: JPK · Hematology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting. It is designed for use on the following automated reticulocyte counting. It is designed for use on the following reticulocyte analyzers: Abbott Cell-Dyn 4000, 3700, 3500, and 3200,

Device Story

Retic-Chex for Cell-Dyn is an in vitro diagnostic hematology control; consists of stabilized human red blood cells and simulated human reticulocytes in 1.0ml plastic vials. Used in clinical laboratory settings to validate performance of automated reticulocyte counting on Abbott Cell-Dyn analyzers. Provides two levels of reticulocyte percentage ranges (1.5-2.0% and 3.9-5.8%). Laboratory technicians process the control through the analyzer similarly to patient samples; output is a reticulocyte count value. Comparison of output against established assay ranges allows verification of instrument accuracy and precision; ensures reliable patient testing results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Suspension of stabilized human red blood cells and simulated human reticulocytes. Packaging: 1.0ml plastic vials with injection-molded polypropylene screw-top caps. Multi-level control (two levels). No electronic, software, or energy-based components.

Indications for Use

Indicated for use as an assayed quality control material for laboratories performing reticulocyte counting via automated, semi-automated, or manual methods.

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

• Retic-Chex® Linearity (K000115)

Submission Summary (Full Text)

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K042587

510(k) Summary of Safety and Effectiveness

510(k) Submitter: Streck Laboratories 7002 South 109th Street La Vista, NE 68128

Official Correspondent: Carol Thompson, Quality Assurance Manager [phone]

September 17, 2004 Date Prepared:

| Names of Device: | |
|----------------------|--------------------------------------------------------------------|
| Trade Name: | Retic-Chex for Cell-Dyn® |
| Common Name: | Hematology Reagents |
| Classification Name: | Hematology quality control mixture, 21CFR864.8625 |
| Predicate Device: | Retic-Chex® Linearity manufactured by Streck Laboratories, K000115 |

## Description:

Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.

## Intended Use:

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting. It is designed for use on the following automated reticulocyte counting. It is designed for use on the following reticulocyte analyzers: Abbott Cell-Dyn 4000, 3700, 3500, and 3200,

## Comparison with Predicate Device:

Like Retic-Chex Linearity, Retic-Chex for Cell-Dyn is a multi-level device intended for validation of reticulocyte analysis on a variety of automated hematology instruments. Both devices contain stabilized human red blood cells and simulated human reticulocytes, which properly mimic human whole blood on the intended use analyzers.

## Testing Performed:

Three studies of Retic-Chex for Cell-Dyn were conducted: 1) Closed Vial Stability: 2) Open Vial Stability; and 3) Manual Count Closed Vial Stability. Study results showed Retic-Chex for Cell-Dyn to be consistently reproducible and stable for the entire product dating.

## Conclusions Drawn from the Tests:

Study results show Retic-Chex for Cell-Dyn to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Retic-Chex for Cell-Dyn is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# OCT 1 9 2004

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

Re: k042587

> Trade/Device Name: Retic-Chex for Cell-Dyn® Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: September 17, 2004 Received: September 22, 2004

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.

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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 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., 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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510(k) Number (if known):

K042587

Device Name: Retic-Chex for Cell-Dyn®

Indications For Use:

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.

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
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD42587

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