LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

K123198 · Bio-Rad Laboratories · JJY · Nov 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123198
• Device Name: LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Ethanol/Ammonia Control is an assayed quality control serum used in clinical laboratories to monitor the precision of testing procedures for ethanol and ammonia. The device is prepared from bovine serum albumin with added chemicals, stabilizers, and preservatives. It is provided in a liquid form. Laboratory personnel use the control to verify the performance of their testing instrumentation and reagents by comparing observed results against the provided mean values and ±3SD ranges. This monitoring helps ensure the accuracy and reliability of patient test results, allowing clinicians to make informed diagnostic and treatment decisions based on valid laboratory data.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were performed to validate shelf life (24 months at 2-8°C) and open vial stability (20 days at 2-8°C on Siemens Dimension Vista instrument).

Technological Characteristics

Bovine serum albumin matrix with added chemicals, stabilizers, and preservatives. Liquid form. Storage at 2-8°C. Analyte content: Ethanol and Ammonia. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for ethanol and ammonia. No specific patient population is described as this is an in vitro diagnostic control product.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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K1231'98

Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Ethanol/Ammonia Control

Page 1 of 3

## Summary of Safety and Effectiveness Liquichek Ethanol/Ammonia Control

#### 1.0 Submitter

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

### Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

November 15, 2012

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Ethanol/Ammonia Control |
|---------------------|---------------------------------------------|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
| Classifications: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

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

| Predicate Device Information | |
|------------------------------|--------------------------------------------|
| Device Name: | Liquichek Ethanol/Ammonia Control |
| Applicant: | Bio-Rad Laboratories |
| 510(k) Number: | K955024 |
| Product Code: | JJY |
| Regulation #: | 862.1660 |
| Device Classification Name: | Multi-analyte Controls. All Kinds(Assayed) |

#### 4.0 Description of Device

Liquichek Ethanol/Ammonia Control is prepared from bovine serum albumin with chemicals, stabilizers and preservatives added. This control is provided in liquid form for convenience.

#### 5.0 Intended Use

Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

NOV 2 0 2012

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#### 6.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as quides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications

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

Liquichek Ethanol/Ammonia Control claims substantial equivalence to the Liquichek Ethanol/Ammonia Control currently in commercial distribution under 510(k)K95024. Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

| Characteristics | Liquichek Ethanol/Ammonia Control<br>(New Device) | Liquichek Ethanol/Ammonia Control<br>(Predicate Device under K955024) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Ethanol/Ammonia Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for the<br>analytes listed in this package insert. | Liquichek Ethanol/Ammonia Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for the<br>analytes listed in this package insert. |
| Matrix | This product is prepared from bovine<br>serum albumin with added chemicals,<br>stabilizers and preservatives. | This product is prepared from bovine<br>serum albumin with added chemicals,<br>stabilizers and preservatives. |
| Form | Liquid | Liquid |
| Storage unopened<br>(Shelf life) | Until the expiration date when stored at<br>2 to 8°C | Until the expiration date when stored at<br>2 to 8°C |
| Analytes | Ethanol<br>Ammonia | Ethanol<br>Ammonia |
| Differences | | |
| Fill Size | 2.5 mL | 3 mL |
| Open Vial Stability | 20 days at 2 to 8°C on board Siemens<br>Dimension Vista instrument | 20 days at 2 to 8°C |

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

#### 8.0 Statement of Supporting Data

Stability studies have been performed and met the acceptance criteria for Liquichek Ethanol/Ammonia Control (New Device) to determine the open vial and shelf life claims. Product claims are as follows:

Open Vial Stability:

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## Sheif Life Stability

24 Months at 2 to 8°C

#### 9.0 Conclusion

Liquichek Ethanol/Ammonia Control (New Device) is intended to be used for the same intended use as the predicate. It has bovine serum albumin matrix and performs similarly as the predicate device

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

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## DEPARTMENT OF HEALTH & HUM AN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2012

Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k123198

Trade/Device Name: Liquichek Ethanol/Ammonia Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJY Dated: October 8, 201-2 Received: October 25, 2012

Dear Ms. Suzanne 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 either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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## Page 2 - Suzanne Parsons

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 Diagnostics and Radiological Health 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,

## Carol C. Benson

for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

123198 510(k) Number (if known):

Liquichek Ethanol/Ammonia Control Device Name:

Indications for Use:

Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The following analytes are included in the package insert:

1. Ethanol 2. Ammonia

X Over-The-Counter Use Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung. Chan

Division/Sign-Office of In Vitro Diagnostics and Radiological Health

510(k) k123i98