LIQUICHEK WHOLE BLOOD VOLATILES CONTROL

K041561 · Bio-Rad · DIF · Jul 6, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041561
• Device Name: LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jul 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Whole Blood Volatiles Control is a liquid, human blood-based quality control material; used in clinical laboratories to monitor precision of toxicology testing procedures. Device contains specific analytes: Acetone, Ethanol, Isopropanol, Lead, and Methanol. Laboratory personnel use the control to verify performance of analytical test systems. By comparing measured values against expected ranges, clinicians ensure accuracy and reliability of patient test results. Product is stored at 2°C to 8°C; stable for 5 days after opening.

Clinical Evidence

No clinical data. Bench testing only; stability studies performed to validate shelf life (2 years at 2-8°C) and open-vial stability (5 days at 2-8°C).

Technological Characteristics

Human blood-based matrix; liquid form; contains broad-spectrum anti-microbial cocktail (<0.1% concentration); no sodium azide. Analytes: Acetone, Ethanol, Isopropanol, Lead, Methanol. Storage: 2°C to 8°C.

Indications for Use

Indicated for use as a quality control material to monitor the precision of laboratory testing procedures for specific analytes (Acetone, Ethanol, Isopropanol, Lead, Methanol) in human whole blood samples.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Whole Blood Tox Control (K821975A)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Liquichek Whole Blood Volatiles Control

#### 1.0 Submitter

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist [phone] Telephone:

## Date of Summary Preparation

June 08, 2004

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Whole Blood Volatiles Control |
|---------------------|-----------------------------------------|
| Common Name: | Clinical Toxicology Control Material |
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |

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

Whole Blood Tox Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K821975A

#### 4.0 Description of Device

This product is prepared from human blood with chemicals and preservatives added. The control is provided in liquid form for convenience.

#### 5.0 Intended Use

Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

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### 6.0 Preservatives:

The Liquichek Whole Blood Volatiles Control does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.

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

Liquichek Whole Blood Volatiles Control claims substantial equivalence to Whole Blood Tox Control currently in commercial distribution (K821975A).

| Characteristics | Bio-Rad Laboratories<br>Liquichek Whole Blood Volatiles Control<br>(New Device) | Bio-Rad Laboratories<br>Whole Blood Tox Control<br>(Predicate Device K821975A) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Whole Blood Volatiles Control is intended for use<br>as a quality control material to monitor the precision of<br>laboratory testing procedures for the analytes listed in the<br>package insert. | Use Whole Blood Tox quality control material, assayed, to<br>monitor the precision of whole blood toxicology test<br>procedures. |
| Form | Liquid | Liquid |
| Matrix | Whole Blood | Whole Blood |
| 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 |
| Open Vial | 5 days at 2°C to 8°C | 5 days at 2°C to 8°C |
| Differences | | |
| Analytes | Contains the following analytes:<br>● Acetone<br>● Ethanol<br>● Isopropanol<br>● Lead<br>● Methanol<br>Does not contain:<br>● Phenylalanine | Contains the following analytes:<br>● Ethanol<br>● Isopropanol<br>● Lead<br>● Methanol<br>● Phenylalanine<br>Does not contain:<br>● Acetone |

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

### 8.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Whole Blood Volatiles Control. Product claims are as follows:

- 8.1 Open Vial Stability: 5 days at 2 to 8°C.
- 8.2 Shelf Life: 2 years at 2 to 8°C.

Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

**JUL - 6 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

k041561 Re: Trade/Device Name: Liquichek Whole Blood Volatiles Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 8, 2004 Received: June10, 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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## Page 2

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,

Jean M. Cooper MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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):

K04156/

Device Name:

Liquichek Whole Blood Volatiles Control

Indications For Use:

Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Prescription Use V (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)

Alberts Caz
Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041561