LIQUID ASSAYED MULTIQUAL CONTROL

K043208 · Bio-Rad · JJY · Jan 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043208
• Device Name: LIQUID ASSAYED MULTIQUAL CONTROL
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquid Assayed Multiqual 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.

Device Story

Liquid Assayed Multiqual is a quality control serum derived from human serum supplemented with purified biochemical materials, chemicals, drugs, preservatives, and stabilizers. It is used by laboratory technicians to verify the performance of clinical chemistry instruments. The device serves as a control material to monitor the accuracy and precision of laboratory testing procedures. The current submission introduces Lactic acid as an additional analyte to the existing formulation. The product is provided in liquid form and is stored at 2 °C to 8 °C. Stability is verified through open-vial aging and accelerated stability testing to ensure analyte concentration remains within specified limits over time.

Clinical Evidence

Bench testing only. Stability studies were performed to determine open vial stability (14 days at 2-8°C, with exceptions) and shelf life (3 years at -20°C or colder).

Technological Characteristics

Quality control serum prepared from human serum, purified biochemical materials (human/animal tissue extracts), chemicals, drugs, preservatives, and stabilizers. Liquid form. Stability verified via open-vial aging and accelerated temperature testing.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for various analytes in human serum samples.

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

• Liquid Assayed Multiqual (K011867)

Submission Summary (Full Text)

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K043208

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## Summary of Safety and Effectiveness Liquid Assayed Multiqual

JAN - 7 2005

#### 1.0 Submitter

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

November 16, 2004

#### 2.0 Device Identification

| Product Trade Name: | Liquid Assayed Multiqual |
|---------------------|-------------------------------------------------|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

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

Liquid Assayed Multiqual Bio-Rad Laboratories Irvine, California

510 (k) Number: K011867

#### 4.0 Description of Device

Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.

. . . . . . . . . .

#### 5.0 Intended Use

Liquid Assayed Multiqual 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.

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

Liquid Assayed Multiqual claims substantial equivalence to the Liquid Assayed Multiqual currently in commercial distribution (K011867). Both of these are liquid, human serum based controls. The new Liquid Assayed Multiqual contains the same analytes as the predicate device with the addition of Lactic Acid.

| Characteristics | Bio-Rad Laboratories<br>Liquid Assayed Multiqual Control<br>(New Device) | | Bio-Rad Laboratories<br>Liquid Assayed Multiqual Control<br>(Predicate Device K011867) | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Similarities | | | |
| Intended Use | Liquid Assayed Multiqual is intended for use as an assayed<br>quality control serum to monitor the precision of laboratory<br>testing procedures for the analytes listed in this package insert. | | Liquid Assayed Multiqual is intended for use as an assayed<br>quality control serum to monitor the precision of laboratory<br>testing procedures for the analytes listed in this package insert. | |
| Form | Liquid | | Liquid | |
| Matrix | Human serum based | | Human serum based | |
| Storage (Unopened) | -20°C or colder Until expiration date | | -20°C or colder Until expiration date | |
| Open Vial Claim | 14 days at 2 to 8°C, with the following exception: LAP<br>Arylamidase will be stable for 3 days. | | 14 days at 2 to 8°C, with the following exception: LAP<br>Arylamidase will be stable for 3 days. | |
| | Differences | | | |
| Analytes | Contains: | | Contains:<br>Same analytes as the new device with the exception of Lactic Acid. | |
| | Acetaminophen<br>Alpha-1-Antitripsin<br>αHBDH<br>Apolipoprotein A-1<br>Apolipoprotein B<br>Alkaline Phosphatase (ALP)<br>ALT/SGPT<br>Amikacin<br>Amylase<br>Amylase, Pancreatic<br>AST/SGOT<br>Acid Phosphatase<br>Albumin<br>Bilirubin, Direct<br>Bilirubin, Neonatal<br>Bilirubin, Total<br>C3 Complement<br>C4 Complement<br>Ceruloplasmin<br>Cholinesterase<br>Calcium, Ionized<br>Copper<br>Calcium, Total<br>Carbamazepine<br>Carbon Dioxide (CO2)<br>Chloride<br>HDL<br>LDL<br>Cholesterol, Total<br>CK-MB Isoenzyme<br>Cortisol<br>Creatinine<br>Creatine Kinase (CK)<br>Ferritin<br>Ethanol<br>Digoxin<br>GGT<br>Gentamicin<br>Globulin<br>Glucose | Iron<br>Immunoglobulin A (IgA)<br>Immunoglobulin G (IgG)<br>Immunoglobulin M (IgM)<br>TIBC<br>UIBC<br>Lactate (Lactic Acid)<br>LDH<br>LAP Arylamidase<br>Lipase<br>Lithium<br>Magnesium<br>Osmolality<br>Phenobarbital<br>Phenytoin<br>Phospholipids<br>Phosphorus<br>Potassium<br>Prealbumin<br>PAP<br>Protein Electrophoresis<br>Protein, Total<br>Salicylate<br>Sodium<br>T3 Free<br>T3 Total<br>T3 Uptake/T-Uptake<br>T4 Total<br>T4 Free<br>Theophylline<br>TSH<br>Tobramycin<br>Transferrin<br>Triglycerides<br>Urea<br>Urea Nitrogen (BUN)<br>Uric Acid<br>Valproic Acid<br>Vitamin B12<br>Zinc | | |

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

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#### Statement of Supporting Data 7.0

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

| 7.1 | Open vial | 14 days at 2 to 8°C, with the following exception: LAP Arylamidase will be stable for 3 days. |
|-----|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2 | Thawed and Unopened: | 30 days at 2 to 8°C, with the following exceptions: Total Bilirubin values may decrease, Alkaline Phosphatase activity may rise. The control must be stored frozen when using AST methods without pyridoxal-5-phosphate. |
| 7.3 | Shelf Life Stability | 3 Years at -20°C or colder |

・・・・・

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

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・・・・・

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DEPARTMENT OF HEALTH & HUMAN 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 stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 7 2005

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

Re: k043208

> Trade/Device Name: Liquid Assayed Multiqual Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 16, 2004 Received: November 19, 2004

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) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally preshand nedicate 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/industry/support/index.html

Sincerely yours,

Carelia B. Looks

Cornelia B. Rooks, MA Acting 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):

510(k) Number (if known): K043208

Device Name:

Liquid Assayed Multiqual

Indications For Use:

Liquid Assayed Multiqual 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.

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
acting

Office of In Vitro Diagnostic Device Evaluation and S

510(k) KD43208

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