LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

K091303 · Bio-Rad Laboratories · JPK · Aug 2, 2010 · Hematology

Device Facts

• Record ID: K091303
• Device Name: LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
• Applicant: Bio-Rad Laboratories
• Product Code: JPK · Hematology
• Decision Date: Aug 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).

Device Story

Liquichek Hematology-16 Control LV is an assayed quality control material used to monitor the precision of hematology analyzers. It consists of a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. The device is provided in 1.5 mL glass vials with screw caps. It is used in clinical laboratory settings by technicians or laboratory staff to verify the performance of hematology analyzers by comparing measured values against assigned ranges. The control is stored at 2°C to 8°C, with a shelf life of 160 days and an open-vial stability of 21 days. By providing an objective assessment of instrument precision, it helps ensure the reliability of patient blood cell counts and indices.

Clinical Evidence

No clinical data. Bench testing performed per CLSI EP5-A2 guidelines. Precision study conducted over 20 days (two runs/day, duplicate) across three levels of control. Total precision standard deviations were compared to instrument manufacturer claims using chi-square tests; all p-values were > 0.05, indicating no statistically significant difference in precision performance.

Technological Characteristics

Suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. 1.5 mL glass vials with screw caps. Storage: 2°C to 8°C. Shelf life: 160 days. Open vial stability: 21 days. Standard referenced: CLSI EP5-A2.

Indications for Use

Indicated for use as an assayed hematology control to monitor the precision of hematology analyzers measuring blood cell parameters (GRAN, HCT, HGB, LYMPH, MCH, MCHC, MCV, MID, MONO, MPV, PLT, RBC, RDW, WBC). No specific patient population or contraindications described.

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 Hematology-16 Control (formerly known as TRI-COUNT 16) (k902389)

Submission Summary (Full Text)

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# Bio-Rad Laboratories Liquichek Hematology-16 Control LV Premarket Notification Section 510(k)

### 1.0 Submitter

Bio-Rad Laboratories 524 Stone Road, Suite A Benicia, California 94510 Telephone: [phone] Fax: [phone]

## Contact Person

Suzanne S. Parsons Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

July 30, 2010

## 2.0 Device Identification

| Product Name: | Liquichek Hematology-16 Control LV |
|--------------------|------------------------------------------------------------------------|
| Common Name: | Hematology and Pathology Devices<br>Hematology quality control mixture |
| Classification: | Class II |
| Product Code: | JPK |
| Regulation Number: | 21 CFR 864.8625 |

### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16) Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Benicia, CA 94510

510 (k) Number: K902389

#### 4.0 Description of Device

This product is a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells and constituents of animal origin in a medium containing stabilizers and preservatives.

#### 5.0 Intended Use

Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells),

K 091303

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MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).

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

Liquichek Hematology-16 Control LV claims substantial equivalence to the Liquichek Hematology-16 Control currently in commercial distribution (K902389).

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

| Characteristics | Bio-RadLaboratories<br>Liquichek™ Hematology-16 Control LV<br>(New Device) | Bio-Rad Laboratories<br>Liquichek™ Hematology-16 Control<br>(Formerly known as TRI-COUNT 16)<br>(Predicate Device K902389) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Hematology-16 Control LV is Intended for use as<br>an assayed hematology control to monitor the precision of<br>hematology analyzers that measure the following<br>parameters: GRAN (Granulocytes), HCT (Hematocrit),<br>HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean<br>Corpuscular Hemoglobin), MCHC (Mean Corpuscular<br>Hemoglobin Concentration), MCV (Mean Corpuscular<br>Volume), MID (Mid-Sized Cells), MONO (Monocytes),<br>MPV (Mean Platelet Volume), PLT (Platelets), RBC Red<br>Blood Cells), RDW (Red Blood Cell Distribution Width),<br>and WBC (White Blood Cells). | Liquichek Hematology 16 Control is a hematology reference<br>control used in monitoring determinations of blood cell values<br>on cell counters. |
| Form | Liquid | Liquid |
| Matrix | suspension contains blood cells | suspension contains blood cells |
| Preservatives | Contains preservatives | Contains preservatives |
| Storage (Unopened) | 2°C to 8°C | 2°C to 8°C |
| Open Vial Claim | 21 days at 2 to 8°C | 21 days at 2°C to 8°C |
| Analytes | Contain the following parameters<br>GRAN (Granulocytes)<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 (Mid-Sized cells) / MONO (Monocytes)<br>MPV (Mean Platelet Volume)<br>PLT (Platelets)<br>RBC (Red Blood Cells)<br>RDW (Red Blood Cells Distribution Width)<br>WBC (White Blood Cells) | Contain the following parameters<br>GRAN (Granulocytes)<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 (Mid-Sized cells) / MONO (Monocytes)<br>MPV (Mean Platelet Volume)<br>PLT (Platelets)<br>RBC (Red Blood Cells)<br>RDW (Red Blood Cells Distribution Width)<br>WBC (White Blood Cells) |
| Differences | | |
| Fill Volume | 1.5 mL | 3.0 mL |
| Vial Type | Glass vials | Glass tubes with pearceable caps |

### 7.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:

- 7.1 Open vial Stability:
All analytes will be stable for 21 days at 2 to 8°C.

- 7.2 Shelf Life Stability: 160 days at 2-8°C

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## 8.0 Statement of Supporting Data

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

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Bio-Rad Laboratories Ms. Suzanne Parsons Regulatory Affairs Representative 9500 Jeronimo Road Irvine, California 92618

AUG 0 2 2010

Re: k091303

Trade/Device Name: Liquichek Hematology-16 Control LV Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control Regulatory Class: Class II Product Code: JPK Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. Parsons:

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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Ms. Suzanne Parsons

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 Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

m chan

Maria M. Chan, 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

# AUG 0 2 2010

# 510(k) Number (if known): K 0 9 130 3

Device Name:

Liquichek Hematology-16 Control LV

Indications For Use:

Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), WBC (White Blood Cells).

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091303

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