MODIFICATION TO PARA 5X

K021922 · Streck Laboratories, Inc. · JPK · Jun 25, 2002 · Hematology

Device Facts

• Record ID: K021922
• Device Name: MODIFICATION TO PARA 5X
• Applicant: Streck Laboratories, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.

Device Story

Para 5X is a tri-level hematology control consisting of stabilized human red blood cells, human white blood cells, and simulated platelets. It is packaged in 3 ml glass vials with pierceable polypropylene screw caps. The device is used in clinical laboratory settings to verify the accuracy and precision of ABX Pentra 60 C+ and Beckman Coulter AcT hematology analyzers. By providing known assay values for CBC/Diff parameters, the control allows laboratory personnel to monitor the performance of counting procedures and ensure the reliability of patient test results.

Clinical Evidence

Bench testing only. Studies conducted to establish performance of Baso % and # addition, including open vial stability, long-term shelf-life stability, and alternate/off-site testing. Results confirmed the device is reproducible and performs within established claims.

Technological Characteristics

Tri-level multi-parameter hematology control; stabilized human red blood cells, human white blood cells, and simulated platelets; packaged in 3 ml glass vials with pierceable polypropylene screw caps. No changes to formulation or intended use; device provides stable Baso information for specific hematology analyzers.

Indications for Use

Indicated for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter AcT hematology analyzers to monitor the performance of CBC/Diff parameters.

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)

Submission Summary (Full Text)

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K021922

## JUN 2 5 2002

### Special 510(k): Device Modification Para® 5X - K011410

#### Summary of Safety and Effectiveness

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

Official Carol Thompson Quality Assurance/Regulatory Affairs Manager Correspondent: [phone]

Date Prepared: June 5, 2002

- Names of Device: Trade Name: Para® 5X Assayed hematology control Common Name: Classification Name: Hematology Quality Control Mixture
Predicate Device: STaK-Chex (K911582), manufactured by Streck Laboratories, Inc.

Description: Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.

Intended Use: Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.

Design Control Activities: Para 5X has not undergone a formulation or intended use change. Para 5X was evaluated on instrumentation for the ability to provide stable Baso information.

Testing Performed: Studies were conducted to establish performance of Para 5X Baso % and # addition; Open Vial Stability, Long-Term Stability (Shelf Life) and Alternate/Off-Site testing. All testing showed that Para 5X is consistently reproducible and performs within the claims.

Conclusions Drawn from the Tests: Para 5X is a safe and effective product useful for controlling the counting procedures of ABX Pentra 5X C+ and Beckman Coulter AcT hematology analyzers. It will perform as claimed when used in accordance with the package insert instructions.

The brand and product names of the instruments are trademarks of their respective holders

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 2 5 2002

Mr. Paul Kittelson Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th Street La Vista. Nebraska 68128

k021922 Re: Trade/Device Name: Para® 5X Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: JPK Dated: June 5, 2002 Received: June 11, 2002

Dear Mr. Kittelson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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| | CALLERS POST PARTICULAR |
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PARA® 5X

510(k) Number:

Device Name:

Indications For Use:

Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcTTM hematology analyzers. It includes assay values for CBC/Diff parameters.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Date: Date:

Amorphine Bautié

(Division Sidn-Off) Division of Clinical Laboratory Devices

510(k) Number.