QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K073080 · Bio-Rad Laboratories · JJY · Jan 24, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073080
• Device Name: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Quest Diagnostics Serum Chemistry Control is a multi-analyte quality control material prepared from human serum supplemented with purified biochemical materials, chemicals, preservatives, and stabilizers. Provided in three levels, it serves as a reference to monitor the precision of laboratory testing procedures for a broad panel of general chemistry analytes, including enzymes, lipids, electrolytes, and metabolites. The device is intended for use in clinical laboratories using the Olympus AU5400 instrument. Healthcare providers use the control to verify the performance of their testing systems; results falling within established lot-specific ranges indicate that the laboratory's testing procedures are operating within acceptable precision limits. The product is handled as potentially infectious human-source material.

Clinical Evidence

No clinical data. Evidence consists of bench-top stability studies confirming open-vial stability (30 days at 2-8°C), closed-vial alternate storage (6 months at -10 to -20°C), and shelf life (2 years at -20 to -70°C).

Technological Characteristics

Human serum-based control material; liquid form; contains stabilizers and preservatives. Analyte list includes enzymes, lipids, electrolytes, and proteins. Storage requirements: -20°C to -70°C (shelf), -10°C to -20°C (alternate).

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specified analytes in clinical laboratory settings.

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.

Predicate Devices

• Quest Diagnostics Serum Chemistry Control (k033387)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Quest Diagnostics Serum Chemistry Control

#### 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 26, 2007

#### 2.0 Device Identification

| Product Trade Name: | Quest Diagnostics Serum Chemistry Control |
|---------------------|-------------------------------------------------|
| Common Name: | Multi-Analyte Controls, (Assayed and Unassayed) |

CFR 862.1660

Class I

JJY

Classifications: Product Code: Regulation Number:

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

Bio-Rad Laboratories Quest Diagnostics Serum Chemistry Control Irvine, California Docket Number: K033387

#### 4.0 Description of Device

Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals, preservatives, and stabilizers have been added.

#### 5.0 Statement of Intended Use

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

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

Quest Diagnostics Serum Chemistry Control claims substantial equivalence to the Quest Diagnostics Serum Chemistry Control currently in commercial distribution (K033387). The new Quest Diagnostics Serum Chemistry Control contains the claims for the same analytes as the predicate device, with the addition of new claims for LDL.

K073080

JAN 2 4 2008

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| Table 1. Similarities and Differences between new and predicate device. | | | | | | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Quest Diagnostics | | Quest Diagnostics | | | |
| Characteristics | Serum Chemistry Control<br>(New Device) | | Serum Chemistry Control<br>(Predicate Device) | | | |
| Similarities | | | | | | |
| Intended Use | Quest Diagnostics Serum Chemistry Control is intended<br>for use as a quality control serum to monitor the<br>precision of an individual laboratory's automated and<br>manual-testing procedures. | | Quest Diagnostics Serum Chemistry Control is<br>intended for use as a quality control serum to monitor<br>the precision of an individual laboratory's automated<br>and manual-testing procedures. | | | |
| Form | Liquid | | Liquid | | | |
| Matrix | Human serum based | | Human serum based | | | |
| Other ingredients | Stabilizers and preservatives | | Stabilizers and preservatives | | | |
| Open Vial Claim | 30 days at 2-8°C | | 30 days at 2-8°C | | | |
| Differences | | | | | | |
| Shelf Storage<br>Claim (Unopened) | -20°C to -70°C<br>Until expiration date | | -10°C to -20°C<br>Until expiration date | | | |
| Alternate Storage<br>Claim (Unopened) | 6 months at -10°C to -20°C | | None | | | |
| Analytes | Contains:<br>- Alanine Aminotransferase<br>- Albumin<br>- Alkaline Phosphatase (ALP)<br>- Amylase<br>- Aspartate Aminotransferase<br>(AST/SGOT)<br>- Bilirubin, Direct<br>- Bilirubin, Total<br>- Blood Urea Nitrogen<br>- Calcium<br>- Chloride<br>- Cholesterol<br>- Cholesterol, HDL<br>- CO2<br>- Creatine Kinase (CK)<br>- Creatinine<br>- Low Density Lipoprotein (LDL) | | - Gamma-Glutamyltransferase<br>- Glucose<br>- Iron<br>- Iron-Binding Capacity,<br>Unsaturated (UIBC)<br>- Lactate Dehydrogenase<br>(LDH)<br>- Lipase<br>- Magnesium<br>- Phosphorous<br>- Potassium<br>– Sodium<br>- Thyroxine (T4)<br>- T3 Uptake<br>- Total Protein<br>- Triglycerides<br>- Uric Acid | Contains:<br>- Alanine Aminotransferase<br>- Albumin<br>- Alkaline Phosphatase (ALP)<br>- Amylase<br>- Aspartate Aminotransferase<br>(AST/SGOT)<br>- Bilirubin, Direct<br>- Bilirubin, Total<br>- Blood Urea Nitrogen<br>- Calcium<br>- Chloride<br>- Cholesterol<br>- Cholesterol, HDL<br>- CO2<br>- Creatine Kinase (CK)<br>- Creatinine | | - Gamma-Glutamyltransferase<br>- Glucose<br>- Iron<br>- Iron-Binding Capacity,<br>Unsaturated (UIBC)<br>- Lactate Dehydrogenase<br>(LDH)<br>- Lipase<br>- Magnesium<br>- Phosphorous<br>- Potassium<br>- Sodium<br>- Thyroxine (T4)<br>- T3 Uptake<br>- Total Protein<br>- Triglycerides<br>- Uric Acid<br>Does not contain:<br>- LDL |

## 7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Serum Chemistry Control. Product claims are as follows:

- . Open vial: 30 days when stored tightly capped at 2-8°C.
- . Alternate Stability (Closed vial): 6 months when stored at -10 to -20°C.
- . Shelf Life: Two years when stored at -20 to -70°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.

08_SSE_Quest Serum Chemistry_591 10/07

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping, curved lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JAN 2 4 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bio-Rad Laboratories c/o Ms. Maria Zeballos Regulatory Affairs Specialist 9500 Jeronimo Road Irvine, CA 92618-2017

k073080 Re:

> Trade Name: Quest Diagnostics Serum Chemistry Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 10, 2007 Received: December 17, 2007

Dear Ms. Zeballos:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., 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):

Ko73080

Device Name:

Indications For Use:

Quest Diagnostics Serum Chemistry Control

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

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)

Carol C. Benson
Sign-Off

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Of In Vitro Diagnostic Device ation and Safety

K073080