QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

K042446 · Bio-Rad Laboratories, Inc. · JJW · Nov 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042446
• Device Name: QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Nov 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

qUAntify® Control and qUAntify® Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. For Prescription Use Only

Device Story

qUAntify® Control and qUAntify® Plus Control are liquid matrix quality control solutions used in clinical laboratories to monitor the precision of urinalysis test procedures. The controls contain human erythrocytes, leukocytes (in Plus version only), animal-derived constituents, chemicals, and preservatives. They are provided in two levels. Laboratory personnel use these controls to verify the performance of urinalysis assays by comparing observed results against assigned values provided in the package insert. This process ensures the reliability of patient test results for various analytes, including glucose, hCG, protein, and specific gravity, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data. Stability studies performed to determine open vial stability (31 days at 2-8°C or 18-25°C) and shelf life (two years at 2-8°C).

Technological Characteristics

Liquid matrix solution containing human erythrocytes, leukocytes, animal-derived constituents, chemicals, and preservatives (<0.1%). Analytes include albumin, creatinine, bilirubin, blood, glucose, hCG, ketones, leukocytes, nitrite, protein, pH, urobilinogen, and specific gravity. Storage at 2°C to 8°C. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of urinalysis test 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

• Liquichek™ Urinalysis Control (K031231)

Submission Summary (Full Text)

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K04 2446

## NOV - 2 2004

Summary of Safety and Effectiveness qUAntify Control and qUAntify Plus 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

September 3, 2004

#### 2.0 Device Identification

| Product Trade Name: | qUAntify Control and qUAntify Plus Control |
|---------------------|---------------------------------------------|
| Common Name: | Urinalysis controls (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJW |
| Regulation Number: | 21 CFR 862.1660 |

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

Liquichek™ Urinalysis Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K031231

#### 4.0 Description of Device

These products are a liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives.

#### 5.0 Intended Use

gUAntify Control and qUAntify Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures listed in their respective package inserts.

#### 6.0 Preservatives:

qUAntify Control and qUAntify Plus Control contain preservatives in a concentration of less than 0.1%. At this low level, the 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.

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K042446

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

gUAntify Control and qUAntify Plus Control claim substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231).

| | Bio-Rad Laboratories | | Bio-Rad Laboratories |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | qUAntify Control and qUAntify Plus Control | | Liquichek™ Urinalysis Control |
| | Characteristics<br>(New Device) | | (Predicate Device -K031231) |
| Similarities | | | |
| Intended Use | [qUAntify Control ] [qUAntify Plus Control] is intended for use as an assayed quality<br>control to monitor the precision of urinalysis test procedures for the analytes listed in<br>this package insert. | | Liquichek Urinalysis Control is intended for use as an<br>assayed quality control urine to monitor the precision of<br>urinalysis test procedures for the analytes listed in the<br>package insert. |
| Form | Liquid | | Liquid |
| Storage Stability | 2°C to 8°C Until expiration date | | 2°C to 8°C Until expiration date |
| Differences | | | |
| Matrix | Liquid matrix solution | | Human Urine |
| Open Vial | 31 days at 2 to 8°C or room temperature (18 to 25°C) | | 30 days at 2 to 8° C or 7 days at room<br>temperature (18-25° C) |
| Analytes | qUAntify Control contains the<br>following analytes: | qUAntify Plus Control contains the<br>following analytes: | Contains the following analytes: |
| | Albumin<br>Albumin-to-Creatinine Ratio<br>Ascorbic Acid<br>Bilirubin<br>Blood<br>Creatinine<br>Glucose<br>hCG<br>Hemoglobin<br>Ketones<br>Leukocytes<br>Nitrite<br>Microalbumin<br>Protein-to-Creatinine Ratio<br>Protein, Total<br>pH<br>Urobilinogen<br>Specific Gravity | Albumin<br>Albumin-to-Creatinine Ratio<br>Ascorbic Acid<br>Bilirubin<br>Blood<br>Crystals<br>Casts<br>Creatinine<br>Glucose<br>hCG<br>Hemoglobin<br>Ketones<br>Leukocytes<br>Microalbumin<br>Nitrite<br>Protein-to-Creatinine Ratio<br>Protein, Total<br>pH<br>Urobilinogen<br>Red Blood Cells (RBC)<br>Specific Gravity<br>White Blood Cells (WBC) | Bilirubin<br>Blood<br>Creatinine<br>Glucose<br>hCG (also described as Pregnancy)<br>Ketones<br>Microalbumin<br>Leukocytes<br>Nitrite<br>Protein-to-Creatinine Ratio<br>Protein, Total<br>pH<br>Urobilinogen<br>Red Blood Cells (RBC)<br>White Blood Cells (WBC)<br>Crystals<br>Casts<br>Osmolality<br>Specific Gravity |
| | Does not contain:<br>Osmolality<br>Red Blood Cells (RBC)<br>White Blood Cells (WBC)<br>Crystals<br>Casts | Does not contain:<br>Osmolality | Does not contain:<br>Albumin<br>Albumin-to-Creatinine Ratio<br>Ascorbic Acid<br>Hemoglobin |

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 qUAntify Control and qUAntify Plus Control. Product claims are as follows:

- Open vial Stability: 31 days at 2 to 8°C or room temperature (18 to 25°C) . .
- Shelf Life: Two years at 2 to 8 °C

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

.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 2 2004

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

k042446 Re: Trade/Device Name: qUAntify® Control qUAntify® Plus Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassyed) Regulatory Class: Class I Product Code: JJW Dated: September 3, 2004 Received: September 9, 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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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, U.S., 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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K042446

# Indications for Use

K042446 510(k) Number (if known): qUAntify® Control Device Name: qUAntify® Control is intended for use as an assayed quality control to Indications For Use: monitor the precision of urinalysis test procedures for the analytes listed in the package insert. qUAntify® Plus Control Device Name: gUAntify® Plus Control is intended for use as an assayed quality control Indications For Use: to monitor the precision of urinalysis test procedures for the analytes

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

listed in the package insert.

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

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Division Sign-Off

of In Vitro Diagnostic

510(k) K042446

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