PARA TECH PLUS RETICS

K993825 · Streck Laboratories, Inc. · JCN · Nov 30, 1999 · Hematology

Device Facts

• Record ID: K993825
• Device Name: PARA TECH PLUS RETICS
• Applicant: Streck Laboratories, Inc.
• Product Code: JCN · Hematology
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Para Tech 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 Bayer Advia 120 and Technicon H-Series hematology instruments.

Device Story

Para Tech Plus Retics is an assayed hematology control used to validate performance of Bayer Advia 120 and Technicon H-Series hematology instruments. The device consists of a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes. It is packaged in 4.0 mL glass vials with polypropylene screw-top caps. Laboratory personnel use the control to verify instrument accuracy for CBC, WBC differential, and reticulocyte analysis. By mimicking human whole blood components, the control allows for simultaneous validation of multiple hematology parameters, ensuring instrument reliability and clinical decision-making accuracy for patient blood counts.

Clinical Evidence

Bench testing only. Four studies were 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 the predicate.

Technological Characteristics

Suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes. Packaged in 4.0 mL glass vials with polypropylene screw-top caps. Designed for use on Bayer Advia 120 and Technicon H-Series hematology instruments. No electronic or software components.

Indications for Use

Indicated for use as a quality control material for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-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

• Para Tech (K896154)

Submission Summary (Full Text)

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NOV 300 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: | November 8, 1999 |
| Names of Device: | |
| Trade Name: | Para Tech Plus Retics |
| Common Name: | Assayed hematology control |
| Classification Name: | White and red cell (and reticulocyte) control (§ 864.8625) |
| Predicate Device: | Para Tech (K896154) manufactured by Streck<br>Laboratories |

- Description: Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: Para Tech 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 Bayer Advia 120 and Technicon H-Series hematology instruments.
- Comparison with Predicate Device: Like Para Tech, Para Tech Plus Retics is intended for CBC/WBC differential performance validation of Bayer Advia 120 and Technicon H-Series hematology instruments. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets which properly mimic human whole blood components on Baver Advia 120 analyzers.

Unlike Para Tech, Para Tech Plus Retics contains a stabilized human reticulocyte component. This allows the Advia 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 Para Tech 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 Para Tech Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn From Tests: Para Tech Plus Retics is safe and effective for controlling CBC/Diff/Retic parameters on Bayer Advia 120 and Technicon H-Series instruments when used as instructed in the product package insert.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 30 1999

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

Re: K993825 Trade Name: Para Tech Plus Retics Regulatory Class: II Product Code: JCN Dated: November 8, 1999 Received: November 12, 1999

Dear Mr. Kittelson:

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 QS 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 Butman

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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K 993825
Not Assigned 510(k) Number (if known): __

Para Tech Plus Retics Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use: Para Tech 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 Bayer Advia 120 and Technicon H-Series hematology instruments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Set E. Maker*

(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices 14993875
510(k) Number

Prescription Use_V (Per 21CFR 801.109)

OR

Over-The-Counter Use (Optional format 1-2-96)

October 6, 1999 ---Date __