STAK-CHEX PLUS RETICS

K992887 · Streck Laboratories, Inc. · GLQ · Nov 22, 1999 · Hematology

Device Facts

• Record ID: K992887
• Device Name: STAK-CHEX PLUS RETICS
• Applicant: Streck Laboratories, Inc.
• Product Code: GLQ · Hematology
• Decision Date: Nov 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

StaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.

Device Story

STaK-Chex Plus Retics is an assayed hematology control consisting of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes. Packaged in 4.5 mL glass vials with polypropylene caps. Used in clinical laboratory settings to validate performance of Beckman/Coulter GenS series hematology analyzers. Provides a stable reference material to ensure accuracy of CBC, WBC differential, and reticulocyte counts. Enables simultaneous control of all three parameters in a single device, improving workflow efficiency compared to predicate devices that lacked reticulocyte components. Healthcare providers use the output to verify instrument calibration and analytical precision, ensuring reliable patient test results.

Clinical Evidence

Bench testing only. Four studies conducted: run-to-run reproducibility, comparison to whole blood, site-to-site reproducibility, and long-term/open-vial stability. Results demonstrated consistent reproducibility and stability for the duration of product dating, confirming substantial equivalence to predicate devices.

Technological Characteristics

Suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes. Packaged in 4.5 mL glass vials with injection-molded polypropylene screw-top caps. Standalone control material for use with Beckman/Coulter GenS series hematology instruments.

Indications for Use

Indicated for use as a quality control material for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.

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

• STaK-Chex (K911582)
• Retic-Chex (K905524)

Submission Summary (Full Text)

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NOV 22 1999

## 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck Laboratories, Inc.<br>P.O. Box 45625<br>Omaha, NE 68145-0625 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Paul Kittelson<br>Quality Assurance/Regulatory Affairs<br>[phone] |
| Date Prepared: | August 25, 1999 |
| Names of Device: | |
| Trade Name: | STaK-Chex Plus Retics |
| Common Name: | Assayed hematology control |
| Classification Name: | White and red cell (and reticulocyte) control (§ 864.8625) |
| Predicate Device: | STaK-Chex (K911582) manufactured by Streck Laboratories<br>Retic-Chex (K905524) manufactured by Streck Laboratories |
| | Description: STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, human |

- D white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.5 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.

Comparison with Predicate Device: Like STaK-Chex, STaK-Chex Plus Retics is intended for CBC/WBC differential performance validation of Beckman/Coulter GenS hematology instruments. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets which properly mimic human whole blood components on Beckman/Coulter STK-S and GenS analyzers.

Unlike STaK-Chex, STaK-Chex Plus Retics contains a stabilized human reticulocyte component. This allows the GenS user to control CBC, WBC differential, and on-line reticulocyte analysis simultaneously with a single device.

- Discussion of Tests and Test Results: Four studies of STaK-Chex Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability. Study results showed STaK-Chex Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn From Tests: STaK-Chex Plus Retics is safe and effective for controlling CBC, WBC differential and reticulocyte parameters on Beckman/Coulter GenS instruments when used as instructed in the product package insert.

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NOV 22 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul Kittelson Ouality Assurance/Regulatory Affairs Streck Laboratories, Inc. 14124 Industrial Road Omaha. Nebraska 68144

Re: K992887 Trade Name: StaK-Chex® Plus Retics Regulatory Class: II Product Code: GLQ Dated: August 25, 1999 Received: August 27, 1999

Dear Mr. Kettelson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __K992887

Device Name: STaK-Chex® Plus Retics __________________________________________________________________________________________________________________________________________

Indications For Use:

StaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992887 |

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)