LIQUICHEK HEMATOLOGY CONTROL (A)

K041457 · Bio-Rad · JPK · Jun 28, 2004 · Hematology

Device Facts

• Record ID: K041457
• Device Name: LIQUICHEK HEMATOLOGY CONTROL (A)
• Applicant: Bio-Rad
• Product Code: JPK · Hematology
• Decision Date: Jun 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Liquichek™ Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology instruments that provide a WBC differential.

Device Story

Liquichek™ Hematology Control (A) is a tri-level, liquid, whole blood hematology control; used in clinical laboratories to evaluate the precision of automated hematology instruments. Composition includes stabilized human white cells, lysable human red cells, and simulated human platelets of animal origin, plus stabilizers and preservatives. Device is processed on Abbott Cell-Dyn 3200, 3500, and 3700 instruments. Healthcare providers use the control to verify instrument performance by comparing measured values against assigned ranges; ensures accuracy and reliability of patient hematology results (WBC, RBC, PLT, etc.).

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated across 4 labs using 2 Abbott Cell-Dyn instruments; results for all parameters (BASO, EOS, HCT, HGB, LYMPH, MCH, MCHC, MCV, MONO, MPV, NEU, PLT, RBC, RDW, GRAN, MID, WBC) showed CVs ranging from 0–10%.

Technological Characteristics

Tri-level liquid control; matrix consists of stabilized human white cells, lysable human red cells, and simulated human platelets of animal origin. Designed for use on Abbott Cell-Dyn 3200, 3500, and 3700 instruments. Open-vial stability is 7 days at 2–8°C.

Indications for Use

Indicated for use as an assayed whole blood control to evaluate the precision of hematology instruments providing white blood cell differentials. Intended for professional clinical laboratory use.

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

• Tri-Count 20 Hematology Whole Blood Control (K960471)

Submission Summary (Full Text)

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K041457

Summary of Safety and Effectiveness Liguichek Hematology Control (A)

## 1.0 Submitter

JUN 2 8 2004

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

## Contact Person

Maria Zeballos Requiatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

May 28, 2004

## Device Identification 2.0

| Product Trade Name: | Liquichek Hematology 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 |

## Device to Which Substantial Equivalence is Claimed 3.0

Tri-Count 20 Hematology Whole Blood Control Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Plano, Texas 75074

510 (k) Number: K960471

## Description of Device 4.0

Liquichek Hematology Control (A) is a suspension of stabilized human white colls, simulated Liquichek Hernalorogy Continer (A) is a suspention of cells. This product onnains soluble human plateles of animal ongin, and lifestablity of the cellular components. This product is provided in liquid form.

### Intended Use 5.0

Liquichek Hematology Control (A) is an assayed whole blood control for evaluating Liquichek Hematology Oonaor (rt) 16- an accurity blood cell differential.

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

Liquichek Hematology Control (A) claims substantial equivalence to the Tri-Count 20 Hematology Whole Blood Control currently in commercial distribution (K960471).

# Table 1. Similarities and Differences between new and prodicate device.

| Characteristics | Bio-Rad<br>Liquichek™ Hematology Control (A)<br>(New Device) | Bio-Rad Laboratories<br>(formerly known as Hematronix, Inc.)<br>Tri-Count 20 Hematology Whole Blood Control<br>(Predicate Device K942295) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology instruments that provide a white blood cell differential | TRI-COUNT 20 is a hematology reference control used in monitoring determination of blood cell values on COULTER STKS, MAXM and other analyzers. |
| Form | Liquid | Liquid |
| 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 | 7 days at 2 to 8°C | 14 days at 2°C to 8°C |
| Analytes | Contain the following parameters same as the predicate:<br>BASO (Basophils)<br>EOS (Eosinophils)<br>HCT (Hematocrit)<br>HGB (Hemoglobin)<br>LYMPH (Lymphocytes)<br>MCH (Mean Corpuscular Hemoglobin)<br>MCHC (Mean Corpuscular Hemoglobin Concentration )<br>MCV (Mean Corpuscular Volume)<br>MID/MONO (Monocytes Mid-Sized Cells)<br>MPV (Mean Platelet Volume)<br>NEU (Neutrophils)<br>PLT (Platelets)<br>RBC (Red Blood Cells)<br>RDW (Red Blood Cell Distribution Width)<br>GRAN (Granulocytes)<br>Does not contain the following parameters:<br>• PDW (Platelet Distribution Width)<br>• PCT (Platelecrit) | Contain the following parameters:<br>BASO (Basophils)<br>EOS (Eosinophils)<br>HCT (Hematocrit)<br>HGB (Hemoglobin)<br>LYMPH (Lymphocytes)<br>MCH (Mean Corpuscular Hemoglobin)<br>MCHC (Mean Corpuscular Hemoglobin Concentration)<br>MCV (Mean Corpuscular Volume)<br>MONO (Monocytes)<br>MPV (Mean Platelet Volume)<br>NEUT (Neutrophils)<br>PLT (Platelets)<br>RBC (Red Blood Cells)<br>RDW (Red Blood Cell Distribution Width)<br>PDW (Platelet Distribution Width)<br>PCT (Platelecrit)<br>Does not contain the following parameters:<br>GRAN (Granulocytes)<br>MID (Mid-Sized Cells) |

## Statement of Supporting Data 7.0

Stability studies have been performed to determine the open vial stability and shelf life for Stablify studies have been performed to estoluct claims are as follows:

- Open vial: All analytes will be stable for 7 days when stored at 2 to 8°C. 7.1
- Shelf Life: 60 days at 2 to 8°C. 7.2

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

JUN 2 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k041457 Re:

Trade/Device Name: Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: May 28, 2004 Received: June 1, 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).

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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.

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,

S. Antman

Robert I.. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology 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): | K041457 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Device Name: | Liquichek Hematology Control (A) | |
| Indications For Use: | Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology Instruments that provide a white blood cell differential. | |
| | The following parameters are listed in the package insert: | |
| • BASO (Basophils) | • MCV (Mean Corpuscular Volume) | • RDW (Red Cell Distribution Width) |
| • EOS (Eosinophils) | • MCHC (Mean Corpuscular Hemoglobin Concentration ) | • RBC (Red Blood Cells) |
| • GRAN (Granulocytes) | • MCH ( Mean Corpuscular Hemoglobin) | • WBC (White Blood Cells) |
| • HGB (Hemoglobin) | • MONO/MID (Monocytes/Mid-Sized Cells) | - NOC (Nucleated Optical Count) |
| • HCT (Hematocrit) | • NEU (Neutrophils) | - WIC (White Impedance Count) |
| • LYMPH (Lymphocytes) | • PLT (Platelets) | - WOC (White Optical Count) |

• MPV (Mean Plateiet Voluma)

Performance claims were established using the Abbott Cell-Dyn 3000.

Prescription Use × (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)

Joachin-Rantala

Office of In Vitro Diagnostic Device Evaluanon and Safe

510(k) K041452

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