AUTION CHECK PLUS

K142262 · Quantimetrix Corp. · JJW · Apr 10, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142262
• Device Name: AUTION CHECK PLUS
• Applicant: Quantimetrix Corp.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The AUTION™ CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

Device Story

AUTION CHECK Plus is a two-level liquid quality control material derived from human urine with added stabilizers and preservatives. It serves as a control for Arkray urine test strips and analyzers. The device is used in clinical laboratory settings to verify the performance of urinalysis testing. Operators (laboratory technicians) dispense the control into a sample tube and process it through Arkray urinalysis analyzers. The device provides known values for analytes including glucose, protein, bilirubin, urobilinogen, pH, blood, ketone, nitrite, leukocytes, and specific gravity. By comparing analyzer results against established control ranges, healthcare providers ensure the accuracy and reliability of patient urinalysis testing, thereby supporting clinical decision-making and diagnostic confidence.

Clinical Evidence

Bench testing only. Accelerated and real-time stability studies were conducted to establish shelf-life and open-vial stability claims. Value assignment was confirmed via laboratory analysis using three operators and three Arkray urinalysis analyzers, with results required to fall within pre-defined specification ranges.

Technological Characteristics

Liquid control material derived from human urine; contains stabilizers and preservatives. Packaged in 25 mL plastic squeezable bottles with dropper tips. Requires refrigerated storage (2-8°C). Shelf life of 18 months; open-vial stability of 30 days at 2-8°C. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic quality control procedures using Arkray urine test strips and analyzers.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2015

QUANTIMETRIX CORP. KALYNA SNYLYK 2005 MANHATTAN BEACH BLVD. REDONDO BEACH CA 90278-1205

Re: K142262

Trade/Device Name: AUTION CHECK Plus Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJW Dated: March 09, 2015 Received: March 09, 2015

Dear Kalyna Snylyk:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stayce Beck -S

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

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142262

Device Name AUTION CHECK Plus

#### Indications for Use (Describe)

The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed announg the and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## 510(k) Summary AUTION CHECK Plus (K142262)

#### Submitter:

Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278

#### Contact person:

Kalyna Snylyk Director Regulatory Affairs and Quality Assurance Telephone: [phone] Fax: [phone]

#### Date Summary prepared:

April 10th, 2015

## Device identification:

Product Trade name: AUTION CHECK Plus Common name: Urinalysis Controls, (Assayed) Clinical Chemistry and Clinical Toxicology Devices Review Panel: Classifications: Class I, reserved Product code: JJW Regulation number: 21 CFR 862.1660

#### Device to which substantial equivalence is claimed

Dropper Urine Dipstick Control Ouantimetrix Corporation Redondo Beach, CA 90278

510(k) number K874890

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Image /page/4/Picture/0 description: The image shows the word "Quantimetrix" in a bold, sans-serif font. To the left of the word is a symbol that looks like two interlocking letter C's. The symbol and the word are both in black, and the background is white. The image is a logo for the company Quantimetrix.

## Description of Device

The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.

The urine donors are screened for HBs antigen , HCV, HIV1, and HIV2, and found to be negative by US FDA accepted methods. human source material used to manufacture this control was tested by FDA accepted methods

#### Value Assignment

The value assignment of each lot of AUTION CHECK Plus control is confirmed by laboratory analysis prior to release. Value assignment confirmation is performed by the Quality Control group in the laboratories of Quantimetrix Corporation. The testing is performed by three different operators using three different Arkray urinalysis analyzers. Each operator and analyzer performs a total of four tests on the control product. For each of the operators and analyzers, the mean of these four test results is then calculated. The means from all three operators and analyzers must fall within the specification range for the lot to be released.

#### Intended use

The AUTION™ CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

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

The new AUTION CHECK Plus claims substantial equivalence to the Dropper Urine Dipstick Control currently in commercial distribution (K874890). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

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Image /page/5/Picture/0 description: The image shows the word "Quantimetrix" in a sans-serif font, with a stylized logo to the left. The logo consists of two interlocking shapes that resemble the letter "C". The text is in black and the background is white.

# Table 1: Similarities and Differences between new and predicate device:

| Characteristics | AUTION CHECK Plus<br>(New device) | Dropper Urine Dipstick Control<br>(Predicate Device K874890) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Same | Is intended as a control for urinalysis<br>reagent strips and analyzers. |
| Vial | Same | Twenty Five mL plastic squeezable<br>bottle with dropper tip. |
| Kit | Same | Each kit contains package insert<br>instructions and 4 x 25 mL Control<br>bottles, 2 Level 1 and 2 Level 2. |
| Storage Condition | Same | Refrigerated (2-8°C) |
| Testing Procedure | Same | Remove the control from the refrigerator and leave it the temperature of 18-25°C for at least 15 minutes Mix by Inversion Return to the refrigerator upon completion of testing |
| Form | Same | Liquid |
| Matrix | Same | Human Urine |
| Closed Vial Shelf Life | Same | At 2-8° C until the expiration date of<br>18 months |
| Differences | | |
| Storage and Stability | Open Vial Stability<br>Once opened, AUTION CHECK Plus<br>can be used for 30 days as long as the<br>unopened expiration date has not passed. | Open Vial Stability<br>When stored at 2-8°C the opened Urine<br>Dipstick Control bottles are stable until<br>the expiration date stated on the label. |
| Testing Procedure | Dispensing of the Control<br>Dispense the required volume of control<br>into a sample tube. Wipe the tip of the<br>control bottle and cap the bottle after<br>dispensing. | Dispensing of the Control<br>Remove cap and invert bottle. While<br>holding dipstick, gently squeeze the<br>sides of the dropper bottle, and touch the<br>tip of the bottle to the dipstick. Draw<br>across all of the reagent pads,<br>thoroughly saturating each pad. |
| Analyte(s) | Glucose, Protein, Bilirubin,<br>Urobilinogen, pH, Blood, Ketone,<br>Nitrite, Leukocytes, Specific Gravity | Glucose, Protein, Bilirubin,<br>Urobilinogen, pH, Blood, Ketone,<br>Nitrite, Leukocytes, Specific Gravity,<br>Albumin, Creatinine, hCG |
| Intended Use | Arkray does not make confirmatory tests<br>so results are not included in the package<br>insert. | Can be used as a control for<br>confirmatory tests such as Acetest,®<br>Clinitest,® and Ictotest® reagent<br>tablets, and for hCG methods. |
| Open vial Stability: | 30 days at 2 to 8°C | |
| Closed vial Stability: | 18 months at 2 to 8°C | |
| Shelf life Stability: | 18 months at 2 to 8°C | |

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Image /page/6/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two interlocking circles on the left, followed by the word "Quantimetrix" in a bold, sans-serif font. The interlocking circles are a stylized design element, and the text is clear and legible.

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Image /page/7/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two interlocking circles on the left, followed by the word "Quantimetrix" in a sans-serif font. The logo is black and white.

#### Statement of Supporting Data:

Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims as follows:

Real time stability studies are ongoing and performed for every lot.

#### Conclusion:

Based on the performance characteristics indicated above, the Aution Check Plus is substantially equivalent to the predicate device Dropper Urine Dipstick Control, reference 510(k) K874890