LIQUICHEK RETICULOCYTE CONTROL (A)

K042836 · Bio-Rad · JPK · Nov 5, 2004 · Hematology

Device Facts

• Record ID: K042836
• Device Name: LIQUICHEK RETICULOCYTE CONTROL (A)
• Applicant: Bio-Rad
• Product Code: JPK · Hematology
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

Device Story

Liquichek Reticulocyte Control (A) is a stabilized human red blood cell product suspended in buffered fluid with animal-derived constituents and preservatives. Supplied in three levels, it serves as an assayed quality control material for clinical laboratories. It is used by laboratory technicians to verify the precision of automated hematology analyzers. By providing known mean values for reticulocyte counts, the control allows laboratories to monitor instrument performance and ensure the accuracy of patient test results over time. The product is stored at 2-8°C and has an open-vial stability claim of 21 days.

Clinical Evidence

No clinical data. Stability studies were performed to establish shelf life (110 days at 2-8°C) and open vial stability (21 days at 2-8°C).

Technological Characteristics

Stabilized human red blood cells in buffered fluid with animal-derived constituents and preservatives. Liquid form. Supplied in three levels. Storage at 2-8°C. Open-vial stability of 21 days at 2-8°C.

Indications for Use

Indicated for use as an assayed whole blood control to evaluate the precision of automated reticulocyte counting methods in clinical laboratory settings.

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

• Liquichek Reticulocyte Control (K993496)

Submission Summary (Full Text)

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K042836
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### Bio-Rad Laboratories NOV - 5 2004 Liquichek Reticulocyte Control (A) Summary of Safety and Effectiveness

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] Fax: [phone]

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

October 11, 2004

#### 2.0 Device Identification

| Product Name: | Liquichek Reticulocyte Control (A) |
|--------------------|-------------------------------------------------------------------------|
| Common Name: | Hematology and Pathology Devices<br>Hematology quality control mixture) |
| Classifications: | Class II |
| Product Code: | JPK |
| Regulation Number: | 21 CFR 864.8625 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Reticulocyte Control Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Benicia, California 94510

510 (k) Number: K993496

#### 4.0 Description of Device

This is a liquid product composed of stabilized human red blood cells suspended in a buffered fluid with added constituents of animal origin and preservatives.

#### 5.0 Intended Use

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

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#### 6.0 Comparison of the new device with the Predicate Device

Liquichek Reticulocyte Control (A) claims substantial equivalence to the Liquichek Reticulocyte Control currently in commercial distribution (K993496). Both of these are liquid, whole blood based controls for evaluating precision of reticulocyte counting.

| Characteristics | Bio-Rad Laboratories<br>Liquichek™ Reticulocyte Control (A)<br>(New Device) | Bio-Rad Laboratories<br>(formerly known as Hematronix, Inc.)<br>Liquichek Reticulocyte Control<br>(Predicate Device K993496) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Reticulocyte Control (A) is an assayed whole blood<br>control for evaluating precision of automated methods of<br>reticulocyte counting. | Liquichek Reticulocyte Control is a whole blood reference control<br>material designed to verify the precision of COULTER<br>instruments equipped with reticulocyte measuring capabilities<br>using VCS technology, and New Methylene Blue Stain. |
| Form | Liquid | Liquid |
| Analytes | Reticulocyte | Reticulocyte |
| Matrix | Human Whole Blood based | Human Whole Blood based |
| Preservatives | Contains preservatives | Contains preservatives |
| Storage (Unopened) | 2°C to 8°C<br>Until expiration date | 2°C to 8°C<br>Until expiration date |
| Differences | | |
| Open Vial Claim | 21 days at 2°C to 8 °C | 31 days at 2 to 8°C |

| | | | | Table 1. Similarities and Differences between new and predicate device. |
|--|--|--|--|-------------------------------------------------------------------------|
|--|--|--|--|-------------------------------------------------------------------------|

#### 7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek Elevated Immunosuppressant Control. Product claims are as follows:

- . Open vial Stability: 21 days at 2 to 8°C.
- . Shelf Life: 110 days at 2 to 8 °C

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017

NOV - 5 2004

Re: k042836

Trade/Device Name: Liquichek Reticulocyte Control (A) Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: October 11, 2004 Received: October 14, 2004

Dear Ms. Platt:

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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# Indications for Use

510(k) Number (if known):

K042836

Device Name:

Liquichek Hematology Control (A)

Indications For Use:

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

Prescription Use _ X (Part 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**

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042836