QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K033387 · Bio-Rad · JJY · Dec 2, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033387
• Device Name: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 2, 2003
• 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 an individual laboratory’s automated and manual testing procedures.

Device Story

Quest Diagnostics Serum Chemistry Control is a liquid, human serum-based quality control material. It contains purified biochemical materials, chemicals, preservatives, and stabilizers. The device is used in clinical laboratories to monitor the precision of automated and manual testing procedures for various serum chemistry analytes. Healthcare providers use the control results to verify the performance and accuracy of their diagnostic testing systems, ensuring reliable patient results. The product is stored frozen (-10°C to -20°C) and has a 10-day open-vial stability when refrigerated at 2-8°C.

Clinical Evidence

Bench testing only. Stability studies were performed to establish shelf life (two years at -10 to -20°C) and open-vial stability (10 days at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Liquid, human serum-based control material. Contains purified biochemical materials, chemicals, preservatives, and stabilizers. Storage: -10°C to -20°C (unopened); 2-8°C (open vial).

Indications for Use

Indicated for use as a quality control serum to monitor the precision of automated and manual laboratory testing procedures for multiple analytes.

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

• Bio-Rad Laboratories Liquid Assayed Multiqual Control (k011867)

Submission Summary (Full Text)

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K03387

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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] [phone] Fax:

# Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

October 15, 2003

# 2.0 Device Identification

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

Classifications: Class I Product Code: JJY Requlation Number: CFR 862.1660

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

Bio-Rad Laboratories Liquid Assayed Multiqual Control Irvine, California Docket Number: K011867

# 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 manualtesting procedures.

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# 6.0 Comparison of the new device with the Predicate Device

Quest Diagnostics Serum Chemistry Control claims substantial equivalence to the Liquid Assayed Multiqual Control currently in commercial distribution (K011867).

| | Quest Diagnostics<br>Serum Chemistry Control<br>(New Device) | Bio-Rad<br>Liquid Assayed Multiqual Control<br>(Predicate Device K011867) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Similarities | | |
| Intended Use | Quest Diagnostics Serum Chemistry Control is<br>intended for use as a quality control serum to<br>monitor the precision of an individual laboratory's<br>automated and manual-testing procedures. | Liquid Assayed Multiqual Control is intended for use as<br>an assayed quality control serum to monitor the<br>precision of laboratory testing procedures for analytes<br>listed in this package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Other ingredients | Stabilizers and preservatives | Stabilizers and preservatives |
| Differences | | |
| Storage<br>(Unopened Frozen) | -10 °C to -20°C<br>Until expiration date | -20°C or colder<br>Until expiration date |
| Open Vial Claim | 10 days at 2-8° C | 14 days 2-8° C |
| Storage<br>(Unopened Thawed) | No claim | 30 days at 2-8° C |
| Analytes | Contains the following analytes that are<br>equivalent to the predicate device:<br><br>ALT; Albumin; Alkaline Phosphatase; Amylase;<br>AST; Direct Bilirubin; Total Bilirubin; Blood Urea<br>Nitrogen; Calcium; Chloride; Cholesterol;<br>Cholesterol, HDL; CO2; Creatine Kinase (CK);<br>Creatinine; Gamma-Glutamyltransferase;<br>Glucose; Iron; Lactate Dehydrogenase (LDH);<br>Lipase; Magnesium; Phosphorous; Potassium;<br>Sodium; T3 Uptake; T4 Total; Total Protein;<br>Triglycerides; Iron-Binding Capacity,<br>Unsaturated (UIBC); Uric Acid. | Contains the following additional analytes not claimed<br>in the new product:<br><br>Acetaminophen; Acid Phosphatase; Amikacin;<br>Amylase, Pancreatic; Bilirubin, Neonatal; Calcium,<br>ionized; Carbamazepine; Cholesterol, HDL;<br>Cholesterol, LDL; CK-MB Isoenzyme; Cortisol; Digoxin;<br>Ethyl Alcohol; Gentamicin; a-1-Antitripsin; HBDH;<br>ApoA; ApoB; C3 Complement; C4 Complement;<br>Ceruloplasmin; Cholinesterase; Copper; Ferritin;<br>Globulin; Lithium; Osmolality; Phenobarbital;<br>Phenytoin; Phospholipids; PAP; Salicylate; T3 Free; T3<br>Uptake/T4 Uptake; T4 Free; Theophylline; TSH;<br>Tobramycin; Valproic Acid; Haptoglobin; IgA ; IgG; IgM:<br>TIBC; LAP Arylamidase; Prealbumin; Protein<br>Electrophoresis, Transferrin; Vitamin B12 Zinc. |

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

# 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:

- 7.1 Open vial: 10 days when stored tightly capped at 2-8°C.
- 7.2 Shelf Life: Two years when stored at -10 to -20 °C.
- 7.3 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 2 2003

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k033387

Trade/Device 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: October 15, 2003 Received: October 24, 2003

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 practicc requirements as set forth in the quality systems (OS) 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K033387

Device Name: Quest Diagnostics Serum Chemistry Control

Indications for Use:

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> For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use X or Over-the Counter use

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K033387