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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AUTION CHECK Plus device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Value Assignment	For each of the three operators and three Arkray urinalysis analyzers, the mean of four test results must fall within the "specification range for the lot."	Confirmed by laboratory analysis prior to release. "The means from all three operators and analyzers must fall within the specification range for the lot to be released."
Open Vial Stability	30 days at 2 to 8°C	Established through accelerated stability studies.
Closed Vial Stability	18 months at 2 to 8°C	Established through accelerated stability studies.
Shelf Life Stability	18 months at 2 to 8°C	Established through accelerated stability studies.
Human Source Material Screening	Urine donors 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"

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For value assignment, the testing involves three operators and three analyzers, with each performing four tests on the control product. This means 3 operators * 3 analyzers * 4 tests = 36 individual tests per lot for value assignment.
Data Provenance: The data is prospective, generated by Quantimetrix Corporation's Quality Control group in their laboratories. The document doesn't specify the country of origin, but given the FDA submission, it's presumably US-based.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three different operators were used for the value assignment process.
Qualifications of Experts: The document does not explicitly state the qualifications of the operators beyond them being "operators" in the Quality Control group.

4. Adjudication Method for the Test Set

Adjudication Method: The value assignment process uses a consensus approach where "The means from all three operators and analyzers must fall within the specification range for the lot to be released." This implies a form of consensus-based adjudication, where all operators/analyzers must agree within a specified range for the lot to be accepted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic device intended for human interpretation or a device designed to assist human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a quality control material; therefore, the concept of an "algorithm" or "human-in-the-loop" performance doesn't directly apply in the same way it would for an AI diagnostic tool. The performance evaluation is based on the chemical properties and stability of the control material, and its ability to produce expected results on Arkray analyzing equipment. The "standalone" performance here refers to the intrinsic characteristics of the control material.

7. Type of Ground Truth Used

For the value assignment (which serves as the "ground truth" for the control material's expected performance), the ground truth is established by internal laboratory analysis, comparing the control material's results against a pre-defined "specification range for the lot." This effectively establishes a known, expected range for the control.
For the stability studies, the "ground truth" is the performance of the device over time compared to its initial established values, under various storage conditions.

8. Sample Size for the Training Set

This product is a quality control material, not an AI or machine learning model that requires a "training set." Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for this device, this question is not applicable.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

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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: (310) 536-0006 Fax: (310) 536-9977

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

Characteristics	AUTION CHECK Plus(New device)	Dropper Urine Dipstick Control(Predicate Device K874890)
Similarities
Intended Use	Same	Is intended as a control for urinalysisreagent strips and analyzers.
Vial	Same	Twenty Five mL plastic squeezablebottle with dropper tip.
Kit	Same	Each kit contains package insertinstructions and 4 x 25 mL Controlbottles, 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 of18 months
Differences
Storage and Stability	Open Vial StabilityOnce opened, AUTION CHECK Pluscan be used for 30 days as long as theunopened expiration date has not passed.	Open Vial StabilityWhen stored at 2-8°C the opened UrineDipstick Control bottles are stable untilthe expiration date stated on the label.
Testing Procedure	Dispensing of the ControlDispense the required volume of controlinto a sample tube. Wipe the tip of thecontrol bottle and cap the bottle afterdispensing.	Dispensing of the ControlRemove cap and invert bottle. Whileholding dipstick, gently squeeze thesides of the dropper bottle, and touch thetip of the bottle to the dipstick. Drawacross all of the reagent pads,thoroughly saturating each pad.
Analyte(s)	Glucose, Protein, Bilirubin,Urobilinogen, pH, Blood, Ketone,Nitrite, Leukocytes, Specific Gravity	Glucose, Protein, Bilirubin,Urobilinogen, pH, Blood, Ketone,Nitrite, Leukocytes, Specific Gravity,Albumin, Creatinine, hCG
Intended Use	Arkray does not make confirmatory testsso results are not included in the packageinsert.	Can be used as a control forconfirmatory tests such as Acetest,®Clinitest,® and Ictotest® reagenttablets, 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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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

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.